Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?
Phase: NA
Conditions: Post Traumatic Stress Disorders
Sponsor: VA Office of Research and Development

NCT02039843 
Can Service Dogs Improve Activity and Quality of Life in Veterans with PTSD? 
Version date:  05/14/2018 
 

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Table of Contents 
 
 
I. 
INTRODUCTION and BACKGROUND .......................................................................... 1 
• 
Significance of Study and Relevance to Veterans: ............................................................. 1 
• 
Overview of PTSD:............................................................................................................. 1 
1. 
How PTSD is Assessed ................................................................................................... 2 
• 
Overview of the Human-Animal Bond: Dogs as Human Companions .............................. 3 
• 
Overview of Emotional Support and Service Dogs ............................................................ 5 
• 
Getting Dogs Partnered with Humans ................................................................................ 6 
• 
Research Completed on Service Dogs ................................................................................ 8 
• 
How Service Dogs can Impact Work and Productivity .................................................... 10 
• 
Cost and Service Dogs ...................................................................................................... 10 
• 
Impact of Service Dogs on Mental Health Characteristics ............................................... 10 
II. 
OVERVIEW OF ORIGINAL STUDY ............................................................................ 12 
• 
Background ....................................................................................................................... 12 
• 
Methods............................................................................................................................. 12 
• 
Enrollment Holds .............................................................................................................. 12 
• 
Current Status.................................................................................................................... 13 
• 
Lessons learned from the original study ........................................................................... 13 
III. 
STUDY OBJECTIVES ..................................................................................................... 16 
• 
Primary Objectives............................................................................................................ 16 
• 
Secondary Objectives........................................................................................................ 16 
IV. 
STUDY OUTCOME MEASURES .................................................................................. 18 
V. 
SUMMARY OF STUDY DESIGN .................................................................................. 19 
• 
Inclusion Criteria .............................................................................................................. 22 
• 
Exclusion Criteria ............................................................................................................. 23 
• 
Safety Monitoring of Children in the Home ..................................................................... 24 
• 
Recruitment ....................................................................................................................... 25 
VI. 
HUMAN RIGHTS ISSUES AND INFORMED CONSENT ........................................... 27 
VII. 
EVALUATION PROCEDURES...................................................................................... 28 
• 
Screening Phase ................................................................................................................ 37 
1. 
Preliminary Screening:.................................................................................................. 37 
2. 
Activities prior to Clinic Qualifying Visit. ................................................................... 37 
3. 
Clinic Qualifying Visit at VA study site. ...................................................................... 38 
4. 
Home Qualifying Visit and Baseline Assessments ....................................................... 38 
• 
Observation Phase ............................................................................................................. 39 
VIII. 
RANDOMIZATION......................................................................................................... 41 
• 
Randomization .................................................................................................................. 41 
• 
Baseline 2 and Home Clearing Visits. .............................................................................. 41 
IX. 
TREATMENT REGIMENS ............................................................................................. 44 
• 
Service Dogs and Emotional Support Dogs...................................................................... 44 
• 
Contract Training Requirements for All Dogs.................................................................. 45 

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• 
Emotional Support Dog Specific Training ....................................................................... 47 
• 
Service Dog Specific Training .......................................................................................... 49 
1. 
PTSD Specific Tasks .................................................................................................... 49 
2. 
Public Access Test (ADI, Public Access test, 2013) .................................................... 51 
• 
Issues related to the dogs: Dog Health and Behavioral Standards for Service Dogs and 
Emotional Support Dogs. .................................................................................................. 53 
• 
Breed, Sex, Weight, and Height Requirements ................................................................ 53 
• 
Medical Requirements ...................................................................................................... 54 
• 
Standards ........................................................................................................................... 55 
• 
Proofing of Dogs ............................................................................................................... 56 
X. 
FOLLOW-UP ASSESSMENTS ....................................................................................... 58 
• 
Pairing Dates: .................................................................................................................... 58 
• 
Week 1 post-pairing visit: ................................................................................................. 58 
• 
Week 2 post-pairing contact: Home visit or telephone call .............................................. 58 
• 
Month 1 visit: .................................................................................................................... 59 
• 
Month 2 contact: ............................................................................................................... 59 
• 
Months 3, 9 and 15 clinic visits and associated telephone calls: ...................................... 59 
• 
Months 6 and 12 home visits: ........................................................................................... 60 
• 
Month 17: .......................................................................................................................... 60 
• 
Month 18 home visit: ........................................................................................................ 60 
1. 
Transfer of Dog Ownership .......................................................................................... 60 
• 
Veterinarian checks ........................................................................................................... 61 
• 
Public observation of study dogs ...................................................................................... 62 
• 
Ad Hoc study Visits .......................................................................................................... 62 
• 
Participant Study Completion ........................................................................................... 63 
XI. 
DOG REMOVALS ........................................................................................................... 64 
• 
Removal and replacement of the study dog. ..................................................................... 64 
1. 
Temporary removals resulting in the return of the same study dog ............................. 64 
2. 
Temporary removals resulting in the pairing of a replacement study dog ................... 65 
• 
Permanent removal of a study dog (Cessation of Intervention) ....................................... 66 
XII. 
STUDY WITHDRAWAL & TERMINATION ............................................................... 68 
1. 
Pre-pairing Terminations .............................................................................................. 69 
2. 
Post-Pairing Terminations ............................................................................................ 69 
3. 
Lost to follow-up: ......................................................................................................... 69 
4. 
Study Withdrawal/Termination Procedures. ................................................................. 70 
XIII. 
MONITORING AND REPORTING ADVERSE EVENTS ............................................ 71 
• 
Importance of Adverse Event Reporting .......................................................................... 71 
• 
Role of the Site Investigator in Adverse Event Monitoring ............................................. 71 
• 
Collection of Safety Information ...................................................................................... 71 
1. 
Adverse Events ............................................................................................................. 71 
2. 
Adverse Event Definitions for Animals ........................................................................ 72 
• 
Adverse Event Follow-Up ................................................................................................ 73 
• 
Serious Adverse Events .................................................................................................... 74 
1. 
Definition of Serious Adverse Event (SAE) ................................................................. 74 
2. 
Serious Adverse Event Monitoring ............................................................................... 74 

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3. 
Expedited Reporting of Serious Adverse Events .......................................................... 74 
4. 
SAE Follow-up Reporting ............................................................................................ 75 
• 
Reporting Adverse Events and Serious Adverse Events to the VA Central IRB ............. 75 
• 
Reporting Adverse Events and Serious Adverse Events to the Study DMC and other 
Oversight Bodies ............................................................................................................... 75 
• 
Reporting Adverse Events and Serious Adverse Events to the IACUC ........................... 76 
• 
Additional Safety Concerns .............................................................................................. 76 
1. 
Unmasking the study treatment .................................................................................... 76 
2. 
Discontinuation of treatment (removal of dog) ............................................................ 76 
• 
Risks to subject ................................................................................................................. 76 
• 
Benefits for study .............................................................................................................. 78 
XIV. HEALTHCARE UTILIZATION & EMPLOYMENT/PRODUCTIVITY ANALYSIS . 79 
• 
Activities of Economic Team ........................................................................................... 80 
1. 
Activities prior to start-up ............................................................................................. 80 
2. 
Activities after study enrollment begins ....................................................................... 80 
3. 
Activities after study follow-up is complete ................................................................. 81 
XV. 
QUALITY CONTROL PROCEDURES .......................................................................... 82 
• 
Standardization/Validation of Measurements ................................................................... 82 
• 
Protocol Violations ........................................................................................................... 82 
• 
Probation/Termination of Participating Centers ............................................................... 82 
• 
Plan to be implemented if enrollment goals are not met .................................................. 83 
XVI. DATA MANAGEMENT.................................................................................................. 84 
• 
Data Security at the VA .................................................................................................... 84 
• 
Data Security for Vendors: ............................................................................................... 85 
• 
Data from pilot study on Service Dogs ............................................................................. 85 
• 
Data Collection and Data Entry ........................................................................................ 85 
• 
Study Documentation and Records Retention .................................................................. 86 
XVII. 
GOOD CLINICAL PRACTICES ................................................................................. 88 
• 
Good Clinical Practices (GCP) ......................................................................................... 88 
• 
GCP Training .................................................................................................................... 88 
• 
Animal Training ................................................................................................................ 88 
• 
Summary of Monitoring and Auditing Plans .................................................................... 89 
XVIII. 
BIOSTATISTICAL CONSIDERATIONS ................................................................... 90 
• 
Study Design and Outcome Measures .............................................................................. 90 
• 
Statistical Methods ............................................................................................................ 93 
• 
Primary Outcome Measures .............................................................................................. 93 
• 
Secondary and Tertiary Outcome Measures ..................................................................... 94 
• 
Economic Outcome Measures .......................................................................................... 95 
• 
Missing Data ..................................................................................................................... 96 
• 
Interim Monitoring............................................................................................................ 96 
• 
Criteria for Study Termination.......................................................................................... 96 
XIX. STUDY ORGANIZATION AND ADMINISTRATION ................................................ 97 
• 
Requirements for Participating Medical Centers .............................................................. 97 
• 
Number of Participating Medical Centers ........................................................................ 98 

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• 
Available Participants at each of the three proposed sites ................................................ 98 
• 
Study Management ........................................................................................................... 99 
• 
Monitoring of the Study .................................................................................................. 100 
1. 
Monitoring bodies ....................................................................................................... 100 
• 
Monitoring participant intake and probation or termination of participating sites ......... 102 
• 
Monitoring data quality and protocol adherence ............................................................ 102 
• 
Monitoring of safety, efficacy and futility ...................................................................... 103 
XX. 
PUBLICATIONS ............................................................................................................ 104 
• 
Publication of Research Results...................................................................................... 104 
• 
Planned Publications ....................................................................................................... 104 
XXI. REFERENCES ............................................................................................................... 106 
 

 
Can Service Dogs Improve Activity and Quality of Life in Veterans with PTSD? 
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I. 
INTRODUCTION and BACKGROUND 
 
In this section we present an overview of the significance and background of dogs for mental 
health conditions.  
 
• Significance of Study and Relevance to Veterans: 
The number of Veterans with post-traumatic stress disorder (PTSD) within the VA population 
has increased dramatically in the past years, largely due to Operation Enduring Freedom and 
Operation Iraqi Freedom (OEF/OIF), but also due to increasing numbers of Veterans from all 
eras seeking treatment and disability claims. PTSD is associated with increased disability and 
decreased mental and health functioning (Gellis et al, 2010; Magruder et al., 2004). Most 
treatments are designed to reduce symptoms, with the expectation that improvements in 
functioning and decrease in disabling health conditions will naturally result; however, for many 
Veterans, PTSD is chronic, and symptom management is the best hope. As with many illnesses, 
which cannot be cured, strategies to decrease limitations on activity and improve quality of life 
are important. The use of Service dogs is a potential strategy that has successfully decreased 
limitations and increased quality of life for individuals with a variety of chronic and disabling 
conditions, including sensory impairments (visual and auditory), seizures, mobility, and mental 
health conditions. 
 
Case studies demonstrate that Service Dogs trained for persons with mental health disabilities 
may fill a need for people with PTSD. As part of the National Defense Authorization Act of 
2010, , Congress enacted a law that stated, “a pilot study would be completed” to determine the 
benefits of Service Dogs in helping individuals with mental and physical disabilities. As a result, 
the following study is proposed. Results of the proposed study are expected to inform future 
medical benefits policy for use of Service Dogs for Veterans with mental health diagnoses, 
specifically PTSD.   
 
• Overview of PTSD:  
PTSD is in the family of trauma and stressor-related disorders in the newly released DSM-V 
(APA, 2013).  The definition requires that a person has experienced a traumatic event and has 
met symptom criteria in 4 clusters: intrusion, avoidance, negative alterations in cognitions and 
mood, and alterations in arousal and reactivity.  Though not codified as an official psychiatric 
disorder until 1980 in the DSM-III, there have been a number of epidemiologic studies over the 
past 30 years – especially among Veterans. 
 
These studies have established that the lifetime prevalence of PTSD in the US population is 7.8% 
(Kessler et al. 1995).  That study also found that the prevalence is about twice as high among 
women as men (5.0% vs. 10.4%), and this has been a consistent finding across a variety of 
populations and methods (Tolin & Foa, 2008).  In US military Veterans, prevalence estimates 
have varied, depending on many factors, including war era, service branch, and deployment 
status.  A recent meta-analysis showed that the odds of PTSD for deployed versus non-deployed 
Veterans varied from 1.42 (for OIF/OEF era) to 3.58 (for Vietnam era) (Magruder and Yeager, 
2009).  New CSP studies demonstrate that: 1) the prevalence of PTSD remains high in male 

 
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Vietnam Veterans (Goldberg et al., in review, a); 2) delayed onset PTSD is not uncommon 
(Magruder et al., in review); and 3) those with PTSD have significantly decreased functioning 
and increased disability (Goldberg et al., in review, b).  The recent doubling of PTSD cases 
among Vietnam-era Veterans seeking VA mental health treatment supports this.  
 
With our better understanding of PTSD in the last 35 years, there have been a number of 
advances in treatment.  In addition to medications (including SSRI’s, sleep medications, 
prazosin), there are a number of successful psycho-social approaches.  These include cognitive 
behavioral treatment, exposure therapy, and eye movement desensitization and reprocessing (or 
EMDR) treatment. 
 
The measure of success for PTSD treatments is reduction in specific symptoms.  As with many 
illnesses, symptoms may abate or be controlled, but functioning may still be affected and 
improvements in quality of life may lag far behind symptom reduction.  Needed are approaches 
for improving functioning and quality of life that can be implemented in concert with existing 
treatments. 
 
In fact, the United Nations published data on PTSD worldwide using disability adjusted life 
years (DALYs) as the metric (WHO, 2004).  These data show that the US was near the top of all 
countries and that PTSD “costs” 58 DALYs per 100,000 population -- the same rate as for 
Parkinson’s disease in the US. 
 
1. 
How PTSD is Assessed 
In 2013, the American Psychiatric Association revised the diagnostic criteria for PTSD in the 
DSM-5 (revision of DSM-4).  Diagnostic criteria include history of a qualifying traumatic event 
and a combination of symptoms from each of the four symptom clusters (intrusion, avoidance, 
negative alterations in cognitions and mood, and alterations in arousal and reactivity) (National 
Center for PTSD, 2013). There are many accepted measures used to assess PTSD symptoms.  Of 
note, several validated measurement instruments are in the process of revision to align with the 
new DSM-5 criteria. 
 
Structured interviews or self-report formats are both acceptable means of PTSD assessment 
and/or diagnosis.  There is a wide range of information included in individual measures, from 
general inclusion of symptoms to very focused measurement of each of the 17 PTSD symptoms 
(National Center for PTSD, 2013).  Information regarding stressful life events in the past and 
about factors involved with past and current adjustment is needed for a thorough assessment. 
This can be accomplished by using multiple sources of assessment data.  This will increase the 
validity of diagnostic classification and treatment planning (Keane, et al, 1987, Litz et al, 1992).  
There is not a “best” measure to assess PTSD although interviews are generally more 
comprehensive assessments. Interviews can help create a link between a traumatic event and the 
development of PTSD symptoms (Litz, et al, 1992).  
 
There are advantages to using self-report formats for PTSD assessments.  These measures are 
less time consuming and thereby less burdensome to both subjects and the research team.  It is 
also noted that obtaining data using a multi-method approach, and incorporating information 

 
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obtained from a variety of sources has been advocated to establish a PTSD diagnosis (Lyons et 
al, 1989; Kulka, et al, 1988, Litz et al 1992).  For purposes of this study, it is felt this multi-
method approach will yield the most comprehensive assessment of PTSD symptoms. 
 
• Overview of the Human-Animal Bond: Dogs as Human Companions 
According to the U.S Census Bureau in 2011 there were more animals living in the United States 
than people. A composition of human-animal companionship in the modern world represents 
various factors that characterize a human-animal bond from demographic, inter-species, and 
economic perspectives. 
 
 
 
Although many animals, including exotic ones, can be defined as human companions, dogs 
predominately build a foundation of what is called a human-animal bond. The originator of the 
modern zoopsychology, or anthrozoology, Dr. Konrad Lorenz, coined this term. Dr Lorenz was 
the co-recipient of the 1973 Nobel Prize for Physiology or Medicine "for their discoveries 
concerning organization and elicitation of individual and social behaviour patterns."A Lorenz 
believed that there is a basic psychosocial mechanism that is responsible for cooperation between 
humans and animals described through the process of trustworthiness occurring when an animal 
learns to recognize another person as trustworthy, and vice versa A. 
 
Research suggests that dogs may have developed the ability to read person’s behavioral and 
communicative cues through a process known as convergent evolution (Hare, 2005) resulting in 
two biological species sharing a similar trait or ability. According to a study published in 2013 
by an international group of scientists (Wang et al., 2013), convergent evolution shaped genes in 
humans and dogs that correspond to diet, behavior, and disease. Most importantly for the 
proposed study is that as a result of more than 32,000 years of cooperation with human beings 
(Ovodov, et al., 2013 ), dogs have developed enhanced social skills that allow them to interact 
with their human companions on many levels, from tactile-kinesthetic to communications 
occurring in complex social situations (Libin, 2006; 2008).   
 
Table 1:  Companion animals 
  
Dogs 
Cats 
Birds 
Horses 
Percent of households owning 
36.5% 
30.4% 
3.1% 
1.5% 
Number of households owning 
43,346,000 
36,117,000 
3,671,000 
1,780,000 
Average number owned per household 
1.6 
2.1 
2.3 
2.7 
Total number in United States 
69,926,000 
74,059,000 
8,300,000 
4,856,000 
Veterinary visits per household per year 
(mean) 
2.6 
1.6 
0.3 
1.9 
Veterinary expenditure per household 
per year (mean) 
$378 
$191 
$33 
$373 
Veterinary expenditure per animal 
(mean) 
$227 
$90 
$14 
$133 

 
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Animal social cognition studies show that dogs adapt to their human companions using cue-
reading abilities allowing them to interpret adequately such complex social interaction cues as 
cross-pointing, reverse directions, and different arm extensions (Soproni et al, 2002; Miklósi, 
2006). Both dogs and humans are predisposed through their tactile-kinesthetic, visual, auditory, 
and communication abilities to pay attention to others in social interactions. Even when a person 
is unaware of his or her involuntary movements, that are part of any human verbal or non-verbal 
communication, the dog is watching the signals and considers those cues a priority before a 
consciously spoken word or manifested gesture (McConnell, 2003). Research also shows that 
dogs, compared to wolves, have a genetically predetermined willingness to observe human faces 
and make eye contact (Miklósi, 2003). 
 
Popular belief holds that pet owners, especially dog owners, enjoy better health than their peers 
who do not own pets. Indeed, exposure to animals, especially dogs, has been shown to have 
positive physiological consequences (Vormbrock et al, 1993; Lynch, 1974). These researchers 
suggest that it could lead to decreased health care utilization. Simply stroking a dog decreases 
physiological arousal, including lowering blood pressure (Vormbrock et al, 1993; Lynch, 1974; 
Schuelke, 1991/1992), decreasing heart rate, and slowing respiration (Friedman, 1980), as well 
as increasing finger temperature (Thoma, 1984). Anderson et al. (1992) examined a large sample 
of healthy clinic patients (n=5,741) in Australia and found that compared to individuals who did 
not own pets, pet owners (primarily dog owners) also had lower triglyceride and cholesterol 
levels, in addition to lower blood pressures. In a national probability sample from Australia 
(N=1011) pet owners were found to have better health and decreased health care utilization as 
measured by number of doctor visits and medication use (Anderson, 1992). According to other 
studies, individuals with companion animals visited the physician less often and used less 
medication (Seigel, 1990; Headey, 1998; Aiyama et al, 1986; McHarg et al, 1995 
 
Friedman et al.’s (1980) landmark study showed that in a population of individuals who had a 
myocardial infarction, pet owners were significantly more likely to survive the first year than 
non-pet owners.  Additional research has shown that petting dogs can lower blood pressure and 
stress levels (Friedmann, 1984). Herzog (2011) sites several studies that have been unable to 
reproduce the earlier positive findings, and suggests that positive effects as a result of pets could 
be questioned. Despite this, dogs continue to be used in a variety of settings to help individuals 
deal with stressful events. Dellinger reported (2009) on the use of dogs for emotional support 
when traumatized witnesses testified in court. Animal assisted therapy (AAT) has shown positive 
results when used with hospitalized children (Tsai et al, 2010), adolescents hospitalized in 
psychiatric units (Bardill & Hutchinson, 1997), and adults on psychiatric units diagnosed with 
borderline anxiety (Barker & Dawson, 1998).  In addition, use of dogs has been beneficial in the 
mental health and well-being of wounded warriors (Beck et al., 2012).  Additionally, a secondary 
data analysis of hospital records indicated that patients who participated in AAT had reduction of 
pain, increased relaxation and calmness, and improvement in attitude during the AAT sessions. 
(Stoffel & Braun, 2006)  
 
Clearly, these collective findings are provocative and raise important questions.  If touching a 
dog can have such a remarkable impact, what might be the long-term effects of human-dog 

 
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interaction, specifically partnership with a Service Dog trained to recognize the needs of its 
human partner?   
 
• Overview of Emotional Support and Service Dogs  
In 1929, Seeing Eye, Inc was the first program, which trained dogs for the blind (Sachs-Ericcson 
et al., 2002).  Since that time, additional companies have been created which train dogs to help 
individuals with a variety of disabilities.  The manner in which the dog assists individuals varies 
and is a function of the needs of the individual. Table 2 provides an overview of the different 
types of dogs utilized by people with disabilities and the dog’s purpose. 
 
 
 
Table 2: Types of Dogs for People with Disabilities 
 
Type of dog 
Purpose 
Guide dog 
Helps visually impaired with navigation  
Hearing dog 
Alerts individuals with hearing impairments to different sounds, 
such as phone ringing, doorbell, approaching traffic 
Seizure alert dog 
Signals the onset of seizures, stays with individual during seizures, 
may go for help or call 911 
Mobility dog 
Retrieves objects, braces during transfers, pulls wheelchairs, acts 
as stabilizer 
Mental health dog 
Tasks vary depending on source accessed, but may include: 
reminding the handler to take medicine, providing safety checks or 
room searches, interrupting self-mutilation, and removing 
disoriented individuals from dangerous situations (Working like 
dogs, 2013). Mental health dogs are known under different names 
including Psychiatric Service Dogs. In this study, ‘Service Dogs’ 
are synonymous for mental health dogs. 
Emotional Support Dog 
Provide emotional support for people with disabilities. Unlike the 
dog types listed above, these are not considered service dogs.  
 
Dogs trained to perform tasks that assist a person’s disability are considered “Service Dogs.” 
Tasks can include alerting and protecting a person who is having a seizure, guiding a person who 
is blind, or helping an individual with PTSD to integrate into society by doing tasks such as 
block (stand in front of handler to give space) or watch (stand behind handler to give space). 
Service Dogs work, thus are not considered pets. The task a dog has been trained to perform 
must be directly related to the person’s disability. Service Dogs are protected under the 
Americans with Disabilities Act (ADA). This Act states that a protected animal is entitled to 
enter any public building, that the management of the business may ask what tasks the dog 
performs, but not what the disability is that the person has. In addition, only if the animal is 
misbehaving (i.e., dog is out of control and cannot be brought under control by handler or is not 
housebroken) can the management of that business request the dog and handler to leave (ADA, 
2011). 
 

 
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In contrast, Emotional Support Dogs are accurately characterized as pets. The term itself, 
Emotional Support Animal, is a Department of Justice term for a pet that provides therapeutic 
benefit to its owner with a disability through companionship and affection. Not specifically 
trained to help with a person’s disability, Emotional Support Dogs are expected to be well 
behaved including being house trained and not posing a danger to others.  Dogs whose sole 
function is to provide comfort or emotional support do not qualify as service animals under the 
ADA and thus are not allowed in public buildings. However, Emotional Support Dogs, a type of 
Emotional Support Animal, are protected under the US Department of Justice, Civil Rights 
Division (DRC, 2011). In the U.S., the Fair Housing Act and the Air Carrier Access Act of 1986 
are two federal laws that grant special privileges to owners of Emotional Support Animals. The 
Fair Housing Act has a provision, which allows individuals with disabilities to live in housing 
with their Emotional Support Animal without being charged additional rent. The Air Carrier 
Access Act provides a process in which a person with a disability may travel with his/her animal, 
as long as it has been prescribed and the owner has appropriate documentation (DRC, 2011). 
Table 3 provides summary information on the two types of dogs (DRC, 2011).  
 
Table 3: Allowable Accommodations for Service and Emotional Support Dogs  
 
Accommodation 
Service Dog 
Emotional Support Dog 
Housing  
 
Yes. Documentation of 
disability may be needed.  
Yes. Documentation of disability may 
be needed. 
Public Space 
 
Yes.  
No.  
Airline Travel  
Yes.  
 
Yes. Recent (within one year) 
documentation needed from a licensed 
mental health professional regarding 
the need for the dog. 
 
 
• Getting Dogs Partnered with Humans  
For the person who wants a Service Dog, it most often begins with an application process.  This 
process varies depending on the vendor providing the dog. Most vendors request documentation 
of need from the person’s healthcare provider. This documentation of need provides the vendor 
with guidance as to the disabilities that the individual has and what tasks the dog should be 
trained to do. The recipient of the dog usually undergoes an extensive interview process, 
potentially a home visit, and is expected to attend intensive training with his/her Service Dog, 
which can last upwards of three weeks.  Training approaches vary by vendors.  Many conduct 
group training, while others prefer one-on-one training. 
 
After the intensive training with their Service Dog, the individual will return to their normal 
schedule and begin to work as a team with their Service Dog. Many vendors conduct a follow up 
review at approximately one year to ensure that the dog has maintained an acceptable level of 
performance and remains healthy. Additional training may be done if the needs of the individual 
change due to their disability or social need.  

 
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The type of dog used varies among vendors because of the types of tasks the dog may be asked 
to perform. For example, hearing dogs tend to be small to medium sized dogs that are energetic 
and attentive to sounds.  Bigger dogs (such as Retrievers and Labradors) are often used in 
situations where physical stability of an individual is needed. The most commonly used multi-
purpose Service Dogs are Golden Retrievers, Labrador Retrievers, and crosses of these two.  
These breeds are popular as Service Dogs because they are typically good-natured dogs that are 
of adequate size to perform mobility tasks but not so large they are difficult to accommodate in 
public settings (i.e., restaurants and public transportation) (ADI- breeds, 2013).   
 
Larger vendors who produce Service Dogs have extensive breeding programs, whereas smaller 
vendors will use animals rescued from shelters. Regardless of where the dog comes from, 
temperament is essential to having a well-trained, calm dog to complete the tasks required. Many 
of the vendors producing dogs use ‘puppy raisers’ which provide initial care, obedience training, 
and socialization for the dogs when they are young. The puppy raising stage lasts upwards of 12-
14 months, at which point the dog returns to the vendor for more advanced training. It is at the 
advance training stage that the dog will learn the tasks specific to the individual in need.  
 
Providers of Emotional Support Dogs may range from local animal shelters to vendors of Service 
Dogs.   In either case, the provider has determined that these animals are best suited to 
be companion (pet) animals.  Similar to the Service Dog application process, the person will be 
asked to provide information about their personality, lifestyle, and ability to care for the dog.  A 
mental healthcare professional may provide a letter indicating that the person would benefit from 
the companionship and affection.  Emotional Support Dogs do not receive any specific training 
that would benefit the recipient; they are expected to be well-behaved pets in the home and 
public settings that allow dogs on the premises.  For the purposes of this study, all Emotional 
Support Dogs will have earned American Kennel Club Canine Good Citizen (CGC) certification, 
both basic and advanced tests.  Based on the information obtained during the application process, 
the provider will identify a dog that is suitable for the person based on their personality and 
lifestyle.  The Emotional Support Dog assigned by the provider to a given person will be shipped 
to a VA designated holding facility at or near the VA study site; once received a study dog 
trainer will introduce the dog to the recipient.   A study dog trainer will conduct a one-day 
(hands-on) training session with the Emotional Support Dog and the recipient to ensure the 
recipient is prepared to accept the dog, understands the obedience commands, and is competent 
to control the dog. Additional instruction or support will be available from the trainer as needed.  
 
For this study, the Emotional Support Dogs will be purchased from the same vendors as the 
Service Dogs.  These dogs will of the same breed(s) and have undergone the same socialization 
and basic obedience training (CGC basic certified) as the Service Dogs.  In addition, the 
Emotional Support Dogs will pass the advanced version of the CGC certification, termed the 
“AKC Community Canine Test (CGC Advanced, or CGCA).   Generally, an initial follow-up 
review is conducted by the provider organization within the first month of placement. To prevent 
bias from being introduced into the study, VA personnel will provide post-placement support 
instead of the dog vendors. The purpose of this assessment is to determine if bonding of the 

 
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recipient with their Emotional Support Dog has been successful and to address any outstanding 
issues. Annual follow-up reviews are typically not performed.    
 
Although the use of Service Dogs has been around for years, evidence based research is 
limited to show the impact that dogs have on their human partners.  
 
• Research Completed on Service Dogs 
As previously stated, Service Dogs are trained to assist people with disabilities to accomplish 
tasks which permit the individual to be more functional in their home and social environment. 
Often the dogs are trained to help in completion of activities of daily living and instrumental 
activities of daily living (Camp, 2000, Duncan, 1998). Basic activities of daily living (ADL) 
refer to all self-care activities such as mobility, transfers, and dressing. Instrumental activities of 
daily living (IADL) are those tasks beyond self-care that encompass “interaction with the 
physical and social environment” such as shopping, cleaning, and using transportation (Trombly, 
1995). 
 
Much of the research conducted on Service Dogs has had small sample sizes and is observational 
in nature, with few randomized clinical trials. Use of pre-post designs have been common 
(Rintala, 2008; Collins, 2006), trying to capture aspects of the participant’s life prior to receipt of 
the dog and compare it to after.  Winkle et al.’s (2011) literature review of Service Dogs for 
individuals with mobility disorders sited 371 papers that discussed the topic. Of those, only 12 
met a higher level of evidence using the American Academy of Cerebral Palsy and 
Developmental Medicine 5 level evaluation system (Darrah et al, 2008). Of those 12 papers, only 
one randomized clinical trial exists (Allen et al., 1996). Unfortunately, there has been much 
debate about the study, and several researchers (Eames et al., 1996; Rowan, 1996) have criticized 
it. Study concerns included the source of dogs, the lack of attrition, and the high rate of study 
participants returning to work (82 %) -- surprising given the high rate of unemployment of 
individuals with severe disabilities (CDC, 2008). 
 
Despite the limitations, work completed has encompassed a variety of topics. Table 4 provides a 
small summary of studies to date conducted with Service Dogs followed by specific examples of 
outcomes from the studies.  
 
Table 4: Summary of Service Dog Research 
 
Author 
Type of Dog 
Sample 
Size 
Study Design 
Allen, 1996 
Mobility 
N=50 
RCT 
Collins, 2006 
Mobility 
N=152 
Cross-sectional*/four groups 
Eddy, 1988 
Mobility 
N=20 
Prospective/two groups 
Hart, 1996 
Hearing 
N=54 
Cross-sectional/two groups 
Milan, 2004 
Mobility 
N=130 
Cross-sectional*/two groups 
Mowry, 1994 
Hearing 
N=455 
Retrospective 
Valentine, 1993 
Mobility & Hearing N=24 
Retrospective 

 
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Fairmen, 2000 
Mobility 
N=202 
Cross-sectional/no control 
Rintala, 2002 
Mobility 
N=22 
Pre-Post test/no control 
Rintala, 2008 
Mobility 
N=33 
Pre-Post test/two groups 
Lane, 1998 
Mobility 
N=57 
Cross-sectional/no control 
Shintani, 2010 
Mobility 
N=38 
Cross-sectional/two groups 
Groer, 2003 
Mobility & Hearing N=100 
Cross-sectional 
Groer, 2006 
Mobility 
N=123 
18 month follow up 
 
The goal of rehabilitation is to aid those with disabilities and chronic conditions to return 
successfully to life at home and the community. Sayer et al. (2010) reports that 49% of Veterans 
returning from OEF/OIF have problems participating in community type activities. For other 
disabilities, Service Dogs have proven to be instrumental in helping those individuals regain 
independence and live successfully in the community. Collins et al. (2006) presented cross-
sectional findings using data from a large prospective study (Groer, 2006) to ascertain the impact 
on psychosocial well-being and community participation across four groups – people recently 
paired with a Service Dog, people on a wait list to receive a dog, those with a pet and those with 
no pet. Collins’ (2004) results found no significant differences across groups with respect to 
community participation. Groer’s (2006) study, which was a longitudinal assessment of the same 
group of participants, indicated that those subjects on the waiting list to receive a dog had greater 
decreased social interaction than the other three groups (paired with Service Dog, owns a pet, no 
dog).  
 
Eddy et al. (2008) observed the public’s behavior toward individuals using wheelchairs with and 
without their Service Dogs. When an individual had his/her dog, an increased number of 
strangers smiled and initiated conversations compared to when the dog was not present. These 
results were noted first with children and then with adults in a variety of settings (Eddy et al., 
2008; Mader, 1989). Fairman et al. (2000) also reported that those with dogs were more likely to 
engage in society, and they were approached more in public. Hart et al. (1987) reported more 
community participation as measured by shopping trips and more approaches that are social. 
Others have reported similar findings with respect to social interaction and participation in 
leisure activities (Lane, 1998; Rintala, 2002). In converse, Milan (2004) showed that although 
individuals with dogs scored higher on social integrations measured by the Craig Handicap 
Reporting Technique, the difference was not significant.  
 
Some research has indicated that part of why community participation increases is because the 
individual feels safer (Sachs-Ericcsson, 2004). Serpell (1991) showed that the population in 
general feels safer with the presence of a dog. Studies conducted by Fairman (2000), Hart 
(1987), and Valentine (1993) all reported that those with Service Dogs reported feeling safer or 
willing to go out at night by themselves.  Another study reported that the majority of subjects 
(91%) indicated their hearing dog helped with making the participant feel safe and secure in 
his/her environment (Mowry et al, 1994). 
 
Studies cited in Table 4 have also examined quality of life. Shintani (2010) study included 38 
subjects, 10 of whom had Mobility Service Dogs. SF-36 measured quality of life. Significantly 
higher scores (indicating higher quality of life) were seen in the Physical Functioning and Role 

 
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Emotional subscales of the SF-36. The Mental Component Summary score was also significantly 
higher in those who had the Service Dogs. Other studies have shown improved quality of life 
when an individual has a Service Dog (Rintala, 2002).  
 
• How Service Dogs can Impact Work and Productivity 
The Center for Disease Control estimates that 22% of the United States population has a 
disability (CDC, 2008). The CDC also estimates that 84% of the general population is employed. 
Of those with severe disabilities, only 30% are employed. Family income has been correlated 
with activity limitations, as income loss often occurs as a result of disability. Median monthly 
income decreases dramatically with the presence of a disability (e.g., $2250 median income for 
those with no disability compared to $1458 median monthly income for those with a severe 
disability) (CDC, 2008). Developing methods to make it possible for individuals with disabilities 
to work is important.  Several studies (Fairman et al., 2000; Allen et al., 1998) have examined 
Service Dogs and employment with several studies showing that those who are partnered with a 
dog are more likely to be employed (Hart et al., 1996; Groer, 2003; Allen, 1998). Rintala et al. 
(2002) showed non-significant increases in employment after receipt of a Service Dog.  
 
• Cost and Service Dogs 
Some studies have examined cost from the perspective of caregiver needs. Service Dogs can help 
reduce some of the work of caregivers by performing tasks tailored to meet the particular needs 
of their partners (Duncan, 1998). For example, dogs can be trained to brace or provide support 
during transfers, retrieve items, and summon help should it be needed, thus reducing the need for 
a caregiver to be present (Camp, 2000; Fairman, 2000; Lane, 1998). Fairman et al.’s (2000) 
cross-sectional survey reported Service Dog partners used 2.1 less hours of paid and 5.9 less 
hours of unpaid assistance each week after receipt of their Service Dogs. The estimated cost 
savings due to decreased paid assistance hours was $600 per year. Based on the previously 
mentioned estimate of 16,000 Service Dog users in the United States, this represents a potential 
savings of $9.6 million per year due to decreased reliance on paid assistance. Limitations in these 
studies include cross-sectional design resulting in recall bias of previous events and controversial 
studies (e.g. Allen et al’s findings). Others have shown similar findings (Rintala, 2008; Allen et 
al.; 1996).   
 
• Impact of Service Dogs on Mental Health Characteristics 
Research has shown that Service Dogs can be beneficial in helping individuals deal with other 
mental health conditions. Loneliness has been correlated with a greater incidence of anxiety, 
fatigue, and depression (Katcher, 1985). Pet ownership alone was found to reduce loneliness by 
facilitating social interaction and providing constant companionship according to several 
researchers (Vombrock et al., 1988; Lynch et al., 1974; Schuelke et al., 1991). The first study to 
demonstrate the protective effect of pet ownership explored one-year survival of 92 individuals 
who had suffered myocardial infarcts (MIs) (Friedmann et al., 1980). Only three of 53 
individuals who owned pets (six percent) had died at one-year post MI, compared to 11 out of 39 
individuals who did not own pets (28%). All 10 individuals who owned pets other than dogs had 
survived the year. Although some work has shown that  loneliness and depression is not affected 
by the presence of a Service Dog (Collins et al., 2006; Groer, 2006), others have found 

 
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improvements in both constructs when a Service Dog is present (Valentine et al,, 1993; Mowry, 
1994).  
 
Limited published research exists on the benefits of dogs as a treatment for PTSD. Much of what 
has been reported consists of anecdotal reports published online and in lay journals. These 
reports have anecdotally reported on dogs helping individuals with panic disorders (Fields-
Meyer, 2006), bipolar disorder (Smith, 2003), symptoms of PTSD including overcoming 
flashbacks, reduction of nightmares, anxiety, as well as  medication use (Kime, 2012; 
McLaughlin, 2012; Ruiz, 2012; VOA, 2013; News 10, 2013). One study (published online) 
sampled 71 individuals who self-reported information on their demographics, mental health care 
and diagnosis, and information regarding using a Service Dog for help. All but six participants 
were either partnered with a Psychiatric Service Dog or were in the process of receiving one. The 
authors acknowledge that the sample was convenience based, drawn from individuals who are 
members of a psychiatric dog listserve. Based on self-report, in this cross-sectional study, 84% 
of the study population stated their symptoms decreased as a result of having the dog (Esnayra, 
2008).  
 
To our research team’s knowledge, there have been no scientific studies completed on the 
benefits of Service Dogs for Veterans with PTSD. As shown in the literature presented in this 
background section, Service Dogs are efficacious for individuals with other types of disabilities, 
such as spinal cord injury and hearing problems. In addition, some mental health outcomes have 
improved with the introduction of a Service Dog. Given this, further research should be 
conducted to assess the benefit of Service Dogs on individuals with mental health challenges, 
such as Post Traumatic Stress Disorder (PTSD).

 
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II. 
OVERVIEW OF ORIGINAL STUDY 
• Background  
The National Defense Authorization Act of 2010 mandated that a pilot study be conducted to 
examine the efficacy of Service Dogs for Veterans with PTSD. Investigators at the James A 
Haley Veterans Hospital (PI: Shirley Groer) were invited to submit a proposal. After review for 
scientific merit and revised accordingly, the study was approved for funding in April 2011 with 
enrollment of the first subject in June 2011. 
 
• Methods 
Designed as a three-year longitudinal study, Veterans were recruited to determine if Service 
Dogs improve mental health over time compared to Veterans without Service Dogs, and to 
determine the impact of Service Dogs on healthcare costs. Specific outcomes included PTSD 
symptoms, community participation, and health care utilization. What follows is a brief summary 
of events regarding the study along with reasons why this redesign of the study is occurring.  
 
Recruitment of Veterans occurred several ways. Study staff educated Mental Health providers in 
outpatient clinics in the hospital as well as community based outpatient clinics and vet centers.  
Service Dog vendors also referred Veterans to the study team. Many potential participants heard 
about the study by word of mouth from other Veterans.  Once Veterans contacted the study team, 
enrollment into study occurred with eligibility criteria confirmed.  Eligible Veterans were then 
referred to the Service Dog vendors to proceed with their application process.  Veterans 
approved by both the study team and the vendor were placed on a waiting list to receive a dog.  
Once a dog was available, Veterans went to the vendor facility for training. Depending on 
vendor, the training could take three days to three weeks. After pairing, the Veteran went home, 
partnered with their Service Dog. 
 
In the original protocol, two groups of Veterans are followed: Veterans paired with a Service 
Dog (treatment group), and Veterans not paired with a Service Dog (control group).  Please note 
that the original protocol is ongoing. The protocol and measures were identical for both groups 
except for home visits for Service Dog group.  Once consented, Veterans complete surveys every 
three months until paired with a Service Dog. After pairing, Veterans complete the same 
measures at months 3, 6, 9, 12, 18, and 24.  In addition, paired Veterans and their dog are visited 
in the home by the study team and a VA contracted dog trainer.  These visits are done to ensure 
the pairing is successful, to make sure dogs and Veterans are safe and healthy, and to see that the 
training is being maintained at a level necessary for a dog to be considered a Service Dog.  A dog 
trainer is available to paired Veterans for assistance with any behavioral or training issues that 
arise. Veterans in the control group are followed for two years.   
 
• Enrollment Holds 
In January 2012 after two dog bites and a dog death, an administrative hold was instated which 
resulted in no new enrollment of Veterans to the study.  At that time, three vendors (one in 
Colorado and two in Florida) were participating. After intensive site visits, one vendor in Florida 
was awarded a contract. A Data Safety and Monitoring Board was instituted and additional 
safety and monitoring procedures/practices were put into place.  This included additional more 

 
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intensive phone follow up after pairing and the addition of separate quarterly home visits by both 
the study team and vendor.  The study was restarted in June 2012.  
 
Additional vendor issues identified within a month of re-starting the study resulted in a second 
administrative hold.  These issues dealt with the health and wellbeing of the dogs in training. 
Ultimately, discontinuation of the remaining contract occurred.  The study remains on enrollment 
hold, with no new pairings occurring. Additional site visits have taken place to vendors who train 
Service Dogs and to vendors who train working dogs (e.g., TSA, bomb-dogs, and police dogs). 
 
• Current Status 
Currently there are 20 Veterans enrolled in the study. Of those, 13 are paired with Service Dogs.  
There were 40 additional Veterans enrolled at some point but that have dropped from the study 
for various reasons.  There have been nine Veterans paired with Service Dogs who have 
withdrawn.  Of those nine, one Veteran’s dog died, four Veterans returned the dog to the vendor, 
and four dogs remain with their Veteran. Recruitment of control subjects was largely 
unsuccessful, as most Veterans interested in participating wanted a dog.  
 
The 13 paired participants are predominantly Caucasian (92%), male (n=10), with a mean age of 
52, SD=10; range 34-66.  Overall it took an average of 3 months (range=0-10) from enrollment 
before participants were placed with their Service Dog. At enrollment 31% (n=4) reported 
having mobility problems and having children in the home full or part time. Two subjects will 
have completed the 24-month follow up by the end of July 2013. No data has been analyzed at 
this time.  
 
• Lessons learned from the original study 
The original study taught the research team a great deal about what should be considered in 
future research when examining humans paired with dogs. This section addresses some of the 
challenges and helps to provide justification of why the proposed study has been designed 
accordingly. 
 
• Study design: Over the course of the development of the original study to the methods of 
the proposed study, the design has always been challenged. Included in this has been the 
desire for a randomized design, inclusion of a usual care arm, and the amount to time to 
follow Veterans after the receipt of a dog. It is not practical to randomize Veterans to 
receiving a dog, if in fact they do not want a dog. Thus, the typical randomized clinical 
trial (e.g. all individuals with a given diagnosis) would not be appropriate for this study. 
It would only be appropriate if those with a given diagnosis also want a dog. In the 
proposed study, all subjects, at time of recruitment will indicate an interest in owning a 
dog. Also, there have been suggestions to have a waitlist group of Veterans who would be 
randomized as to how long they would be on the waitlist (short versus long). Because 
dogs are not readily available, all Veterans will be waiting at least three months and 
most likely longer. Even the largest dog vendor seldom places more than 200 dogs in a 
given year. Thus, the research team fully expects that the Veterans will be waiting longer 
than three months to obtain their dog.  

 
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• Comparison/control group:  Due to the nature of the intervention, a dog, one cannot blind 
the intervention (e.g., placebo versus intervention), so the question arises as to what is the 
best comparison. Some suggestions have included having a group of Veterans who are 
part of the study and followed, but do not have a dog. Based on experience with the pilot 
study, recruitment of that group will likely be challenging.  Even when Veterans who 
were part of the original study stated they no longer wanted a dog, were not willing to be 
followed.  Additional suggestions for a control condition include letting Veterans be their 
own controls, with a series of pre-measurements prior to receipt of intervention. The 
proposed study includes this feature. Veterans enrolled will be followed at least three 
months prior to receipt of the dog (this is similar to the original study). Most likely it will 
be longer than three months, as the procurement of appropriate dogs will take time. This 
will enable a comparison pre and post randomization (and receipt of the intervention), 
allowing for measurement of a usual care state. In addition, we have added a group of 
Veterans who will receive an Emotional Support Dog for comparison with Veterans who 
receive the more highly trained Service Dogs.  
 
• Participant burden: Throughout the original study, there have been numerous complaints 
about the length of the survey instrument. In 2008, the Department of Veterans Affairs in 
collaboration with the National Institute on Mental Health and Department of Defense 
recommended to keep the survey instruments to a minimum to reduce burden on the 
subject (page 8, 12). For this reason, we have carefully considered the length of each 
questionnaire and are making efforts to ensure that information is not duplicative.  
 
• Information captured: Throughout the course of the original study, subjects have noted 
repeatedly that the measures used to monitor symptom status and community 
participation miss what the dogs are really doing to help them. In the original study, the 
Community Reintegration of Injured Service members (CRIS) were used as a measure of 
community participation. We have chosen not to use the CRIS this time, as the Veterans 
complained about the length of the questionnaire and about the content of the questions. 
Subsequently the Community Integration Questionnaire (CIQ) was used which asks how 
many times a month the individual participates in leisure activities.  The subjects 
complained that the measure did not give them the option to answer the question in a way 
that gives the full picture.  The number of times they participated may not have changed, 
but their dog has allowed them to be less angry or anxious during outings and has made 
them much more enjoyable.  Just asking who cares for the children does not get at the 
heart of whether having the dog has allowed interactions with the children to be less 
stressful and tense, or that the dog keeps the subject from losing their temper and reacting 
the way they typically would have prior to receiving the dog.  Feedback from study 
subjects overall is that the key elements of how the dogs help with PTSD related 
challenges are not being captured by quantitative measures. For this reason, we have 
added some open-ended questions to the post evaluation (e.g., Service Dog/Emotional 
Support Dog Post-Pairing Evaluation). 
 

 
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• Dogs:  Dogs are dogs, and even the most trained dog, if provoked may lash out to protect 
itself. Although the original study had safety measures included, in moving forward, the 
study team has made numerous site visits to dog vendors who supply service animals 
(e.g., mobility dogs) as well as working dog vendors (e.g., supply police dogs). Based on 
the information gained from those site visits, we have written a new Statement of Work 
(SOW). New vendors to supply dogs will use the new SOW.  An approved protocol is 
needed in order to administer a contract; therefore, vendors are unknown at this time. The 
dogs that we will use for the proposed study will be purpose bred (no rescue dogs), have 
an extensive medical work up to ensure well-being, and will be trained to complete 
specific tasks (for the Service Dog group). All dogs (both Service Dog group and 
Emotional Support Dogs) will have completed the Canine Good Citizen test. The Study 
team will include a national dog trainer with extensive experience in providing dogs to 
individuals with PTSD, and a local dog trainer (one per  site).   
  
• Knowledge of dogs: Over the course of the study, the research team has discovered that 
the knowledge of dogs varies across individuals. Ability to know what to look for when 
the dog is ill, taking care of the dog appropriately, and an understanding of dog expenses 
is crucial to health and well-being of the dog. For this reason, we have added a dog care 
course into this new proposal.  
 
In summary, although the original study was reviewed, initiated, successfully recruited Veterans, 
and ultimately paired them with dogs, problems occurred that were beyond the control of the 
research team. Because of the high profile nature of this study, the research team approached the 
Cooperative Studies Program. Subsequently, what follows is the new research design with 
additional safety measures in place to protect Veterans and dogs.

 
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III. 
STUDY OBJECTIVES  
 
The objectives and hypotheses proposed for this study include: 
 
• Primary Objectives 
Objective 1: To examine how limitations on activity and quality of life in Veterans with 
PTSD are impacted by the provision of a Service Dog versus an Emotional Support Dog.  
  
Limitation on activity is defined as the inability to fully engage in important life domains, such 
as cognition, mobility, self-care, and participation in society. For all the hypotheses listed below 
we will examine change over the 18 month intervention period between the two groups of 
participants with PTSD: those who are assigned to receive a Service Dog and those who are 
assigned to receive an Emotional Support Dog.  
  
Hypothesis 1a:  Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive Service Dogs will have improved ability to fully engage in important life domains over 
time as measured by the WHO-DAS 2.0 domain scores and the WHO-DAS 2.0 total score. 
  
Hypothesis 1b:  Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive Service Dogs will have improved quality of life, as measured by the global mental and 
physical health component scores of the VR-12.  
  
• Secondary Objectives 
Objective 2: To examine how mental health is impacted by the provision of a Service Dog 
versus an Emotional Support Dog. 
 
Hypothesis 2a:  Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive a Service Dog will have reduced PTSD symptom severity, as assessed by the PCL-5 
 
 Hypothesis 2b: As compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive a Service Dog will have decreased thoughts of suicide, as assessed by the Columbia-
Suicide Severity Rating Scale (C-SSRS). 
 
Hypothesis 2c:  Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive a Service Dog will have a decrease in depression as assessed by the PHQ-9. 
 
Hypothesis 2d:  Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive a Service Dog will have improved sleep outcomes as measured by the Pittsburgh Sleep 
Quality Index (PSQI) 
 
Objective 3:  To characterize and compare how health care utilization and costs are 
affected by the provision of a Service Dog or Emotional Support Dog. 
  

 
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Hypothesis 3a:  Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive a Service Dog will have lower health care utilization as quantified by inpatient and 
outpatient visits to healthcare providers and to mental health providers.   
 
Hypothesis 3b: Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive a Service Dog will have decreased medication usage as assessed by the medical record.  
 
Hypothesis 3c: Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive a Service Dog will have decreased use of sleep medications as assessed by the medical 
record. 
 
Objective 4:  To characterize and compare how employment and productivity are affected 
by the provision of a Service Dog or Emotional Support Dog. 
 
Hypothesis 4a:  Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive a Service Dog will be more likely to be employed at follow-up. 
 
Hypothesis 4b: Compared to Veterans who receive an Emotional Support Dog, Veterans who 
receive a Service Dog will have greater work productivity as quantified by the Work Productivity 
and Activity Impairment Questionnaire: General Health Problem V2.0.

 
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IV. 
STUDY OUTCOME MEASURES 
 
Primary Outcomes: The primary outcome measures are limitations of activities and quality of 
life.  
 
Hypothesis 1a:  The total score and six domain scores as measured by the World Health 
Organization Disability Assessment Scale II (WHO-DAS 2.0) will define activity limitations.  
The WHO-DAS 2.0 is a structured 36-item instrument, which assesses difficulties in six domains 
of life during the last 30 days.  The domains include:  
 
 
1. Cognition: understanding and communicating with the world  
 
2. Mobility: moving and getting around  
 
3. Self-care: attending to one’s hygiene, dressing, eating and staying alone  
 
4. Interpersonal interactions: getting along with people  
 
5. Life activities: domestic responsibilities, leisure, and work  
 
6. Participation in society: joining in community activities  
 
Hypothesis 1b:  The outcome measure will be the summary measures from the VR-12 instrument 
of health related quality of life as measured by both the Physical Component Summary (PCS) 
and Mental Component Summary (MCS) scores. 
 
Secondary Outcomes: Secondary outcomes include PTSD severity and symptoms, depression, 
sleep, suicide intent, healthcare utilization, healthcare cost, and employment.  
Hypothesis 2a:  The outcome measure will be the Posttraumatic Stress Disorder Checklist (PCL-
5). The PCL-5 is a 20-item self-report measure of PTSD symptoms (in the past month) based on 
DSM-5 criteria with a 5-point Likert scale response format.   
Hypothesis 2b will examine suicidal ideation, which will be assessed by the Columbia-Suicide 
Severity Rating Scale (C-SSRS).  
Hypothesis 2c examines depression, which will be assessed by the Patient Health Questionnaire 
(PHQ-9). 
 
Hypothesis 2d will to measure sleep quality as assessed by the Pittsburgh Sleep Quality Index 
(PSQI) 
 
Hypotheses 3a and 3b: Information on healthcare utilization and costs will be collected from VA 
administrative data sets and with the Health Economics Resource Center (HERC)-developed 
standard questions regarding non-VA outpatient and inpatient utilization. Additionally, HERC 
has developed standardized cost estimates, which will be applied to the healthcare utilization 
data. 
 
Hypotheses 4a and 4b: Employment outcomes will be examined with the Work Productivity and 
Activity Impairment Questionnaire: General Health Problem V2.0.

 
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V. 
SUMMARY OF STUDY DESIGN 
 
The hypotheses will be tested in a 4-5 year prospective randomized study that will include two 
randomized arms (Service Dog and Emotional Support Dog groups).  Veterans randomized to 
Arm 1 will receive a Service Dog, trained for specific tasks to assist with the Veteran’s 
disability. Veterans randomized to Arm 2 will receive an Emotional Support Dog, which has 
suitable behavior characteristics, provides emotional comfort, and has passed the Canine Good 
Citizen test. Veterans in both groups will be followed for 18-months. 
 
Two hundred twenty subjects will be paired with dogs from three VA sites (about 74 per site) 
where they will be evaluated using surveys, interviews, observation, and chart review. All 
participants will be followed prior to receipt of intervention for a minimum of three months. 
During this time, all participants enrolled in the study will also be in usual care with their treating 
mental health provider. Primary measures will be the WHO-DAS 2.0, a validated instrument that 
will assess function, and the VR-12 to assess quality of life. Secondary measures include the 
PCL-5 score to assess PTSD symptoms, healthcare utilization, employment and productivity, 
depression, and suicidal intent. The proposed design of the study follows.  
 

 
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FIGURE 1:  Study Flow  
 
 

 
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FIGURE 1:  Study Flow 
 
   

 
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PARTICIPANT POPULATION 
 
• Inclusion Criteria 
 
1) 
Males and females > 18 years of age. 
2) 
Referral from Mental Health provider that documents PTSD diagnosis. 
3) 
PTSD as a result of any trauma as determined by meeting DSM 5 diagnostic criteria. 
4) 
Enrolled in mental health services at VA and has attended at least one visit in the 90 
days prior to consent.  
 If individual not currently enrolled in mental health treatment decides to enroll 
in such then he/she may become eligible to participate in the study.  
 If individual enrolled in mental health treatment schedules and attends a mental 
health visit then he/she may become eligible to participate in the study  
5) 
Agrees to remain in mental health treatment throughout the duration of the study. 
6) 
Can adequately care for and handle the dog.  
 Adequately caring for a dog requires that participants will be responsible for 
and able to provide food, water, protection, shelter, exercise, transportation, and 
treatment related to their assigned dog.   
 Adequately handling the dog means having the ability to give and reinforce 
obedience commands and control the dog using a leash. 
7) 
Home environment is suitable for a dog.  
 If the home environment can be remedied the individual may become eligible 
to participate in the study.  
 If a participant moves home while enrolled in the study the new home must be 
suitable for a dog.    
8) 
Home environment is structurally and geographically accessible to study staff. 
 If the home is geographically inaccessible to study staff and, the individual 
cannot remedy the situation unless he/she moves home.  The study team will 
not encourage this. If a move takes place, it will be the individual’s 
responsibility to re-contact the study team.  
 If the individual changes home residence while enrolled in the study, the new 
home must be geographically accessible to study staff. If it is inaccessible, the 
dog will be removed and the individual will be withdrawn from the study.    
9) 
Is willing to accept randomization outcome. 
10) 
Has someone to care for the dog during extended absence of the participant.  
 If no one is available to care for the dog but the situation changes then the 
participant may become eligible to participate.  
11) 
Others in home are agreeable to having dog. 
 If others in the home are not agreeable but at a later date the situation changes, 
then the potential participant may become eligible to participate 
12) 
Is willing and able to travel (by air or car) to the dog vendor training site for pairing if 
assigned to receive a service dog. 
 If individual’s unwillingness to travel to a training site changes, he/she may 
become eligible to participate. In this instance, it will be the individual’s 
responsibility to re-contact the study team.   

 
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13) 
Individual has no pet in the home to threaten the bonding and obedience training of 
an assigned study dog. 
 If a household dog lives inside the home and the home is partitioned such that 
there are two or more separate living spaces served by independent 
entrance/exits, and the individual does not live in a partition with a dog, then 
the individual can be eligible.  If a household dog lives primarily outside the 
home in a rural area and the individual is not primarily responsible for feeding 
the dog on a daily basis, then the individual can be eligible. 
 If an individual has pets other than dogs that could interfere with bonding, the 
individual will be scheduled for the screening visits and the relationship will be 
assessed by the dog trainer. 
 If an individual has a household dog or other pet that prevents participation in 
the study but the situation changes, the individual may become eligible to 
participate. In this instance, it will be the individual’s responsibility to re-
contact the study team. 
14) 
Individual can verbalize understanding of consent form, is willing to provide written 
informed consent and to follow study procedures.  
 
• Exclusion Criteria 
1) 
Hospitalization for mental health reasons in the past 6 months 
 Once six months since hospitalization have passed, the individual may become 
eligible to participate in the study 
2) 
Aggressive behavior that would make it unsafe for the dog 
3) 
Diagnosis of psychosis, delusions, dementia, moderate or severe alcohol/substance 
disorder (SUD), or moderate to severe traumatic brain injury as determined by the 
presence or absence of a condition following scoring of MINI responses or as 
documented in chart notes.    
SUD assessment (alcohol/non-alcohol):  
 Ineligibility is based on the presence of a Moderate (4-5 symptoms) to Severe 
(6+ symptoms) SUD as identified by the MINI within the previous 12-month 
period starting from date of the study MINI screening.  
 If a Moderate to Severe SUD has been documented or communicated by the 
referring clinician or potential participant, or is noted in the EMR prior to the 
initial MINI screening visit, individuals should be scheduled for their initial 
screening visit on a timeline commensurate with meeting the 12-month SUDs 
eligibility window.  
 If an individual is identified as ineligible during the initial screening visit (i.e. 
MINI SUDs score ≥4) he/she may be re-evaluated later at the discretion of the 
study team. Re-evaluations should be scheduled based on a timeline 
commensurate with meeting the 12-month SUDs eligibility window (absence 
of a Moderate to Severe SUD for the previous 12 months). If at re-evaluation 
the individual has <4 symptoms, he/she may become eligible to participate in 
the study.  

 
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4) 
Active suicidal intent as determined by a CPRS flag for suicidal intent or an 
endorsement of yes to question 5 (active suicidal ideation with specific plan and 
intent) on the C-SSRS completed at the Clinic Qualifying Visit.   
 An endorsement of yes to question 4 (Active Suicidal Ideation with Some 
Intent to Act, without Specific Plan) without endorsement of question 5 
indicates that the individual needs additional assessment to determine 
eligibility. 
5) 
Homicidal intent or cognitive disabilities that would preclude safety of dog and/or 
ability to participate in the study. 
6) 
Social, mental or physical condition that prevents the individual from either giving 
informed consent or participating in the study. 
7) 
Participation in another unapproved research trial. 
 If the individual is in another unrelated study and both the study Chair/PI of 
this and the other study consider participation in both studies to be acceptable 
then the individual may become eligible to participate in this study. 
 If the study Chair/PI of this and/or the other study consider participation in 
both studies to be unacceptable then, once participation in the other study is 
complete, the participant may become eligible to participate in this study. At 
that time, it will be the individual’s responsibility to re-contact the study team.   
8) 
Has CPRS flag for violent/disruptive behavior. 
9)  
Potential participants who are pregnant/who have a partner who is pregnant, or who 
currently have one or more children younger than age 5 in the household for more 
than 8 hours per day, one day a week will be excluded from the study.  
 If a participant or anyone else in the household becomes pregnant during the 
observation period, the participant will be excluded from the study.  
 Participants who have children in their home/become pregnant after being 
paired with a dog will be evaluated on a case-by-case basis (see Safety 
Monitoring of Children in the Home below)  
 After a total of 10 dogs have been placed with participants who have children 
between the ages of 5 and 10 years, and after each pairing has successfully 
reached and passed the 2-month home visit, this exclusion criterion will be 
revisited for potential inclusion of participants with children younger than 5 
years. 
 
• Safety Monitoring of Children in the Home  
1) The family will be provided with educational materials to review with their children 
using components of the American Veterinarian Medical Association (AVMA) Dog 
Bite Prevention Articles located on the AVMA website 
(https://www.avma.org/public/Pages/Dog-Bite-Prevention.aspx). Participants will 
also be provided with the link to the abovementioned website in order to access 
additional educational resources. 
 
2) The dog trainer will make home visits at weeks 1 and 2 and at months 1 and 2. If, at 
any of these visits, the dog trainer has concerns that the dog is not comfortable in the 

 
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presence of the child, the dog will be removed from the home and the participant will 
be terminated from the study. 
 
3) The study team, participant and her/his family will be instructed to monitor the dog’s 
behavior regarding the dog-child interactions. In particular they will be instructed to 
look out for the following behaviors that may indicate the dog is stressed by the 
presence of the child:  
 Dog actively avoids the child by hiding, moving away., etc. when child 
approaches 
 Dog yawn or licks lips when in the child’s presence  
 Dog snaps or stares at the child  
 Dog’s holds tail higher than horizontal when in child’s presence 
 Dog attempts to herd child away from the veteran or other family members. 
 Dog displays other behaviors towards the child (or others) that concern the 
participant. 
4) Participants who become pregnant or introduce a newborn, infant, or toddler into their home 
environment (i.e., marriage, significant other, etc.) after pairing will be provided with the “Dog 
Safety Education for Newborns and Infants” document (website: 
http://doggonesafe.com/baby_safety_around_dogs). 
 
If the family notices any of the above behaviors the local dog trainer or a member of the local 
study team must be contacted immediately. On the first report of this, the dog trainer will make a 
home visit to evaluate the situation. If the dog trainer has any concerns that the dog is not 
comfortable in the presence of the child, the dog will be removed from the home and the 
participant will be terminated from the study. On following reports of the same or similar 
behavior, the dog trainer will make a home visit on a case-by-case basis.   
 
 
• Recruitment  
There are three participating study sites (Portland, Iowa and Atlanta VA Medical Centers) that 
will focus their combined recruitment efforts on obtaining the final sample size of 220 paired 
participants. To reach this final sample size and control for the rate of attrition, approximately 
300 participants may be consented across all of the sites.   
 
Suggested local recruitment strategies: 
1. In-services to mental health providers at clinics at the VA and surrounding Community 
Based Outpatient Clinics (CBOCs), and Veteran Centers and other Veteran organizations 
will be conducted by members of the study team using a study-approved presentation. 
Follow-up contacts with clinic providers will take place to answer questions that arise 
regarding study details. Clinicians attending the in-service presentations will be 
encouraged to refer Veterans they feel meet the eligibility criteria 
2. Reminder emails with flier attachments sent to mental health providers.  
3. Distribution of IRB approved flyers and brochures to mental health providers, directly to 
potential participants, placed in mental health clinic waiting areas and placed at meeting 
locations of veteran interest groups and organizations. 

 
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4. Vendor and other external professionals’ referrals of potential participants via provision 
of study team contact information, IRB approved flyers/brochures and/or in-service 
presentation. 
5. Advertising via Social media outlets (i.e., VA Facebook page, VA Twitter account), VA 
related newsletters (internal and external), and VA closed circuit TV.  All content will be 
limited to language currently included in the approved study brochure and/or flyer. 
6. Information booths set up at local community events with a focus on Veteran 
populations.  
 
Referrals:  
Potential participants can be: 
• Self-referred.  
• Referred by a local mental health provider via CPRS or other contact.  
• Referred by a dog vendor or other external professional following contact by an 
interested individual. 

 
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VI. 
HUMAN RIGHTS ISSUES AND INFORMED CONSENT 
 
CSP follows the principles of medical research involving human subjects as outlined in the 
Declaration of Helsinki.   
 
Informed consent will be obtained from all CSP study participants prior to participation in this 
study.  Informed consent requires that the participant understand and agree to the study 
procedures, treatments, and risks.  The participant will be explained the voluntary nature of 
participation in the research study and can withdraw from participation without penalty at any 
time.  It will be communicated that current treatment, future medical care, and benefits will not 
be dependent on participation in the research.  The participant must have sufficient time to read 
and discuss the informed consent document prior to signing.   
 
The process of informed consent must occur verbally with the study participant.  In discussion of 
the consent form with the participant, the site investigator (or other study personnel identified in 
this protocol to conduct the informed consent process) may provide additional details beyond 
those contained in the consent form.  Additional information may not represent any significant 
additions, deletions, or modifications to the information in the informed consent document.  The 
research participant will be provided with a paper copy of the consent form and any 
supplementary materials to read and review prior to consent.   
 
The informed consent document will contain all elements as outlined in VHA Handbook 1200.05 
as required by the Common Rule.  The consent will be documented on VA Form 10-1086 
Research Consent Form.  The VA CIRB or other IRB of record for the study will approve the 
consent form prior to its use.   
 
The informed consent must be signed and dated by the study participant and the person obtaining 
the informed consent.  The original signed informed consent document will be placed in the site 
investigator’s research file.  Copies of the signed informed consent document will be provided to 
the participant at the time of consent, the participant’s medical record per VHA Handbook 
1907.01, and to the CSPCC per instructions in the Operations Manual.   
 
The informed consent process will be documented in a detailed progress note prior to study 
participation.     
 
A separate written HIPAA authorization for the use of individually identifiable health 
information must be signed by the research participant. 
 
Data will be retained after the end of the study as per VA and IRB regulations.

 
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VII. 
EVALUATION PROCEDURES 
 
Table 5 provides a summary of forms and data collection tools. Each test measure is described in 
more detail following the table.  
 
Table 5: Summary of Forms and Data Collection Tools 
 
Form 
Purpose 
When Completed 
Who Completes 
Mental Health Referral 
Checklist and Cover 
Letter  
To provide referral 
for potential 
participant  to 
participate in 
research study 
Prior to consent 
Mental health 
provider 
Veteran Characteristics 
(form 01) 
To collect 
information about 
participants 
Screening 
Member of study team 
CAPS (form 03) 
PTSD eligibility 
Clinic Qualifying 
visit, Month 15 
Trained Mental Health 
professional on study 
team 
MINI (form 04) 
Psychiatric 
disorders; Determine 
eligibility 
Clinic Qualifying  
visit,  
Qualified mental 
health professional on 
study team 
Suitability to Have a 
Dog Checklist  (form 
05) 
Home assessment 
checklist to assess  
suitability home 
environment for dog 
placement 
Home Qualifying 
visit, 
Home Clearing Visit, 
ad hoc visits as 
needed 
VA Dog Trainer 
(National or local) or 
another trained 
individual  
Dog Care Test  
Test to assess  
knowledge learned 
by participant 
following Dog Care 
Course    
After completing the 
Dog Care Course,  
Home Clearing visit 
Participant  
C-SSRS (form 11) 
Suicide assessment 
Clinic Qualifying 
Visit, Baseline 2 
visit, and at months 
3, 6, 9, 12, 15 and 18 
Completed in 
interview format 
WHO-DAS 2.0 (form 
07) 
Quantification of 
outcomes 
Baseline 1 visit, 
Baseline 2 visit, and 
at months 3, 6, 9, 12, 
15 and 18 
HERC non-VA care 
and WPAI completed 
in interview format; 
remaining measures 
completed in pen and 
paper format by 
participant.  
PCL-5 (form 08) 
PSQI (form 09) 
VR-12 (form 10) 
PHQ-9 (form 12) 
DAR (form 13) 
HERC non-VA 

 
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Form 
Purpose 
When Completed 
Who Completes 
Inpatient and outpatient 
Care (form 14) 
WPAI: GHP v2.0 (form 
15) 
Post-Pairing Evaluation 
(form 19) 
Assessment of dog-
related issues  
One week post 
pairing and as 
needed 
VA Dog Trainer 
(national or local) 
Medication Log (form 
17) 
Record all Non-VA 
prescribed 
medications the 
participant is taking 
during the trial 
Baseline 1, Baseline 
2, Months 3, 6, 9, 12, 
15, 18  
Study Team 
Protocol Deviation 
(form 25) 
Records all 
deviations from 
stated protocol 
procedures 
As needed 
Study team 
Adverse Event and 
Serious Adverse Event 
Forms (forms 26a, 26b, 
27a, 27b, 28a, 28b)) 
Records all adverse 
events and serious 
adverse events for 
participants and dogs 
As needed 
Study team 
Exit Interview (forms 
24a, 24b) 
Assessment of 
perceived benefits of 
assigned study dog. 
At 18 month visit or 
following the 
permanent removal 
of the study dog (i.e., 
cessation of 
intervention). 
Interview format by 
trained interviewer. 
Dog Trainer Evaluation 
(form 24c) 
Evaluate dog 
training skill level 
At 18 month visit 
Dog Trainer 
Inclusion/Exclusion 
(form 16) 
document study 
eligibility status 
Study withdrawal 
Study team 
Intervention 
Discontinuation (Dog 
Return) Form (form 22) 
Document the 
temporary or 
permanent removal 
of study dogs.  
Complete this form 
for all paired 
participants upon 
return of dog to the 
VA. 
Study team 
Study 
Completion/Termination 
(form 24) 
Document study 
completion of or 
termination from the 
study. 
Complete this form 
for all randomized 
participants upon 
completion of, or 
withdrawal from the 
study. 
Study team 
Informed Consent 
Confirmation (form 86) 
Document informed 
consent process. 
Complete this form 
after the participant 
Study team 

 
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Form 
Purpose 
When Completed 
Who Completes 
has signed the 
Informed Consent. 
Veteran and 
Service/Emotional 
Support Dog Visit 
Report (form 20) 
Observational 
assessment of dog 
behaviors, and dog-
participant 
interactions 
Post-pairing week 1, 
and at months 1, 6, 9, 
12,  Optional at week 
2 and Month 2,  ad 
hoc visits as needed 
VA Dog Trainer 
(national or local). 
Dog Related Questions 
(form 21) 
Reported satisfaction 
with dog and dog 
concerns 
Post-pairing weeks 1 
and 2, and at months 
1, 2, 3, 6, 9, 12, 15 
and 18, ad hoc visits 
as needed 
Completed in 
interview format led 
by VA Dog Trainer 
Veterinary Checklist 
(form 23),  and packet 
contents including 
contact face sheet and 
cover letter  
Assesses wellness of 
dog 
Week 1 (initial), 
Month 06, Month 12, 
Month 18 
Veterinarian selected 
by participant 
Post-pairing survey  
Assessment of 
pairing process 
One week post 
pairing 
Participant 
Reasonable 
accommodation letters 
for Housing and Air 
Travel  
May be required if 
participant lives in 
an apartment and/or 
travels with their 
study dog  
Only used if required  Provided to 
participant as required 
Vendor information 
packets (optional) 
Provides information 
about the vendor and 
post study vendor 
resources. 
Optional: At 18 
month visit when 
available once all 
study related tasks 
have been completed 
and participant 
agrees to keep their 
study dog. 
Information packet 
provided to participant 
when available by the 
assigned vendor. 
Home Suitability Guide  Provides a list of 
items that the dog 
trainer will be 
checking during the 
Home Qualifying 
Visit. Its purpose is 
to assist the 
participant in home 
preparation and to 
allay anxiety 
regarding the Home 
At Clinic Qualifying 
Visit if the individual 
meets CAPS and 
MINI inclusion 
criteria. Can be 
provided as needed 
Information document 
provided to 
participant. 

 
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Form 
Purpose 
When Completed 
Who Completes 
Qualifying Visit. 
Clinician In-service 
Presentation  
Provides overview 
of the study and 
criteria to VA 
clinicians. 
Study recruitment as 
needed. 
Presentation to non-
participants. 
Recruitment Flyer and 
Brochure  
Provide information 
about the study and 
study criteria. 
Study recruitment. 
Available to potential 
participants.  
ICF Visual Aid  
Overview of study 
procedures and 
visits. 
During consent as 
needed. 
Paper format given to 
potential participants. 
Telephone Screening 
Script  
Review study 
criteria prior to 
scheduling the initial 
Clinic Qualifying 
Visit. 
Telephone Screening 
prior to Clinic 
Qualifying Visit. 
Phone interview with 
participant. 
Management Of 
Suicidal Patients  
Provides site specific 
guidelines for 
managing VA 
patient suicidality. 
As needed based on 
reported suicidality. 
Policy guideline 
document. 
Emotional Support Dog 
ID card  
Provides brief 
summary of the 
dog’s rights under 
US law and includes 
a picture 
identification of the 
study dog. 
Provided to the 
participant after 
placement with their 
study dog. 
ID card given to the 
participant. 
Trupanion Flyer and 
Insurance Card  
Provides 
Dog related 
insurance 
information 
including insurance 
ID number. 
Provided to the 
participant after 
pairing/placement 
with their study dog. 
Flyer given to the 
participant. 
Secondary Contact 
Information form  
Emergency contact 
and secondary dog 
caretaker contact 
information. 
Individuals listed on 
the form should be 
aware of the 
participant’s 
involvement in the 
study and have 
agreed to be listed as 
Home Clearing Visit 
and updated 
thereafter. 
Study Team. 

 
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Form 
Purpose 
When Completed 
Who Completes 
a contact. 
Family Education form  
Provides dog 
education materials 
for participants of 
children between the 
ages of 5 and 10 
years children in the 
home full time.  
Provided at the 
Home Clearing Visit 
and reviewed at the 
placement visit for 
EMOTs or Week 1 
visits for SDs. Can 
be provided as 
needed. 
Study Team provides 
printed copies to the 
participant prior to 
pairing and reviewed 
as appropriate in 
proximity to the week 
1 post pairing visit. 
Dog Ownership Chip 
Registry Instructions  
Provides instructions 
on changing the chip 
registry information 
from the VA to the 
participant. 
18 Month visit or 
mailed after the 
completion of the 18 
Month visit 
Provided to 
participants who 
choose to keep their 
study dog 
VA Certificate of Study 
Completion (dog return 
and dog retention 
versions)  
Certificate of study 
completion and dog 
ownership 
18 Month visit or 
mailed after the 
completion of the 18 
Month visit 
Provided to 
participants who 
choose to keep their 
dog 
Transfer of Dog 
Ownership Verification 
Form  
To document the 
participants decision 
to keep or return the 
study dog at the 
successful 
completion of the 
study. 
18 Month visit  
Participant 
Lost to Follow-Up letter  Mailed to 
participants that do 
not respond to phone 
calls. 
As needed 
Sent prior to 
withdrawing the 
participant from the 
study 
Paired Participant 
Withdrawal letter   
Provides 
documentation of the 
withdrawal to the 
participant 
Given to the 
participant at the 
time of withdrawal 
If circumstances 
prevent the direct 
delivery to the 
participant the letter 
can be filed in the 
study record. 
Emotional Support Dog 
Pairing Checklist 
Help ensure that the 
local VA trainer 
provides the Veteran 
with the necessary 
training and 
information needed 
for a successful 
pairing outcome 
with their assigned 
Pairing visit 
Dog Trainer 

 
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Form 
Purpose 
When Completed 
Who Completes 
Emotional Support 
Dog. 
Dog Safety Education 
for Newborns  
Educational 
materials for 
participants who 
become pregnant 
after pairing or 
introduce a newborn, 
infant, or toddler 
into the home after 
pairing (i.e., 
marriage, significant 
other, etc.) 
Provided to the 
participant prior to 
pairing or at anytime 
family status changes 
or potentially 
changes to include 
infants/newborns in 
the home. 
Provided to the 
participant. Can be 
reviewed by a study 
team member. 
Dog Care Sheet  
Educational refresher 
on important health 
components that can 
benefit both the 
bonding relationship 
and health of the dog 
overtime. 
Completion of the 18 
Month Visit. Can be 
provided as needed. 
Provided to the 
participant. Can be 
reviewed by a study 
team member. 
ADA Service Dog 
Public Access Rights 
(pocket card) 
Explains service dog 
legal rights protected 
by the department of 
justice.  
Offered to service 
dog participants after 
unblinding. 
Staff 
  
Measures and forms:  
• Referral checklist: Mental health providers will complete a referral checklist for each 
potential participant.  The checklist will request information about anger management, 
cognitive ability, suicidal ideation, delusions and psychoses, and will request input on 
whether the provider considers it appropriate for the potential participant to have/own a dog.  
• Demographic Interview. The demographic interview obtains data information about the 
participant’s age, marital status, education level, race/ethnicity, service record, employment 
status, and income, activity levels and use of alternative therapies for PTSD.   
• CAPS:  The Clinician Administered PTSD Scale (CAPS) is the gold standard for the 
diagnosis of PTSD (Weathers et al., 2013a). It is a well-validated structured clinical 
interview that measures the intensity and frequency of the 20 DSM-5 PTSD symptoms. It 
includes questions which target the onset and duration of symptoms, subjective distress, 
impact of symptoms on social and occupational functioning, improvement in symptoms since 
previous CAPS (if applicable), overall PTSD severity and specifications for the dissociative 
subtype. The CAPS updated for DSM-V produces a dichotomous assessment of PTSD.   A 
member of the research team who is trained in administering the CAPS will complete the 
assessment.   

 
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• MINI EVALUATION (MINI): To assess the subject’s drug/alcohol dependence, depression, 
and other Axis-I disorders according to DSM –V criteria the MINI, version 7.0.0 will be 
conducted during screening.  A trained interviewer using the MINI screen questionnaire will 
first assess each subject.  If a potential DSM-V disorder is identified via the screen, the 
clinician will administer the corresponding module of the complete MINI interview.  Current 
alcohol dependence will be assessed with the MINI and used as a dichotomous stratification 
factor based on a definite (not probable) diagnosis (yes/no).   
• Confirmation of Ongoing Mental Health Treatment. A member of the study team will 
confirm that the potential participant is enrolled in mental health services at the VA and has 
attended at least one visit in the prior 90 days. For the purposes of this study, acceptable 
ongoing mental health treatment modalities include PTSD therapy, medication review 
(including side effects), case management via a social worker or similar, primary care follow 
up regarding symptoms and/or medications, symptom burden/response, etc.  If primary care 
providers are to be the sole managers of PTSD the medical records should indicate that the 
mental health treatment team has concluded and that no further mental health specialty care 
is currently required. If documentation within the medical records does not clearly describe 
the abovementioned examples, the local LSI must contact other care professionals to 
determine the status of care.  
 
• WHODAS 2.0.  The World Health Organization Disability Assessment Scale II is a 
structured 36-item instrument, which assesses difficulties in six domains of life during the 
last 30 days.  A total disability score is produced as well as domain scores.  The domains 
include:  
1. Cognition: understanding and communicating with the world  
2. Mobility: moving and getting around  
3. Self-care: attending to one’s hygiene, dressing, eating and staying alone  
4. Interpersonal interactions: getting along with people  
5. Life activities: domestic responsibilities, leisure, and work  
6. Participation in society: joining in community activities  
 
The WHO-DAS was chosen after careful consideration of cross-cultural applicability and 
review of existing instruments (Ustun, 2001).  The domains are congruent with and map to 
the International Classification of Functioning, Disability and Health (ICF) (WHO, 2001), 
the WHO manual for the classification of the consequences of disease.  One of the driving 
forces behind development of the WHODAS 2.0 was the international standardization of 
disability measurement and classification that cuts across disease conditions and cultures.  
The linkage between the WHODAS 2.0 and the ICF parallels the relationship between the 
Composite International Diagnostic Interview (CIDI) for psychiatric disorders with DSM-IV 
and ICD-10.  For the WHODAS development, field trials were conducted throughout the 
world on over 65,000 individuals.  These included cross-cultural applicability research and 
two waves of more traditional psychometric testing in geographically and culturally 
representative countries.  Respondents from the general population as well as clinical 
populations, including persons with physical problems, mental or emotional problems, and 
alcohol and drug use related problems, were included (Ustun, 2010.  The end result of these 

 
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investigations was the 36 item WHODAS 2.0.  The total WHODAS 2.0 score has high 
internal consistency (alpha=0.86), a stable factor structure, and high test-retest reliability 
(intraclass correlation=0.98).  The total score also shows a strong correlation with existing 
instruments, Rasch scaling properties across populations, and sensitivity to change (Ustun, 
2010).  In summary, the WHODAS 2.0 will provide an excellent measure of health and 
activity limitation and complement the health related quality life assessment using the 
Veterans RAND 12-Item Health Survey (VR-12).  The WHODAS 2.0 will be completed in 
pen and pencil format by the study participant. It takes 10 to 15 minutes to complete.   
 
• PTSD Checklist- PCL5: The PCL-5 is a 20-item self-report measure that assesses the 20 
DSM-5 symptoms of PTSD.  The PCL-5 is most similar to the PCL-S (specific) version.  The 
wording of PCL-5 items reflects both changes to existing symptoms and the addition of new 
symptoms in DSM-5.  (Weathers et al., 2013b). The PCL-5 will be completed in pen and 
paper format by the study participant. It takes 5 to 10 minutes to complete.   
 
• Pittsburgh Sleep Quality Index (PSQI): The PSQI of [Buysse et al, 1989] is a 24-item survey 
used to assess sleep-related problems during the past month. Nineteen items are completed 
by the subject, and five items are completed by a bed partner or roommate. The five items 
answered by a bed partner or roommate are used as clinical information and are not included 
in scoring. The first 19 items are grouped into seven components (sleep quality, sleep 
latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, 
and daytime dysfunction) each weighted equally on a 0-3 scale. The seven component scores 
are then summed to yield a global score, which has a range of 0-21; higher scores indicate 
worse sleep quality. The seven component scores of the PSQI have an overall reliability 
coefficient (Cronbach’s α) of 0.83. The PSQI will be completed in pen and paper format by 
the study participant. It takes approximately 5 to 10 minutes to complete.   
 
• VR-12: Health Related Quality of Life will be assessed by the VR12, which is a modification 
of the VR-36, a generic health status measure that has been shown to be valid and reliable in 
a wide variety of health care settings (Ware et al,1992; Kazis, 1998). The VR-12  will be 
completed in pen and paper format by the study participant. It takes approximately 5 minutes 
to complete.   
 
• Columbia Suicide Severity Rating Scale (C-SSRS): The C-SSRS is a 4-page form asking 
questions about suicidal ideation, intensity of ideation, and suicidal behavior. Developed by 
Posner and collaborators at the New York State Psychiatric Institute (Oquendo et al., 2003) 
the scale is intended for use by trained administrators.  The questions contained in the C-
SSRS are suggested probes. Ultimately, the determination of the presence of suicidality 
depends on clinical judgment.  Clinical trials C-SSRS training is required for any individual 
administering the C-SSR.   The C-SSRS will be completed in interview format. It takes 
approximately 10 minutes to complete.  
 
• Patient Health Questionnaire (PHQ-9): The PHQ-9 is a diagnostic tool for mental health 
disorders used by health care professionals that is quick and easy for participants to 
complete. In the mid-1990s, Spitzer and colleagues at Columbia University developed the 

 
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Primary Care Evaluation of Mental Disorders (PRIME-MD), a diagnostic tool containing 
modules on 12 different mental health disorders. They worked in collaboration with 
researchers at the Regenstrief Institute at Indiana University and with the support of an 
educational grant from Pfizer Inc. The PHQ, a self-administered version of the PRIME-MD, 
contains the mood (PHQ-9), anxiety, alcohol, eating, and somatoform modules as covered in 
the original PRIME-MD (Kroenke et al., 2002). The PHQ-9 will be completed in pen and 
paper format by the study participant. It takes approximately 5 minutes to complete.  
 
• Dimensions of Anger Reactions (DAR): This seven item scale measures anger disposition 
that is directed to other individuals (Forbes et al, 2004). It has been shown to be reliable and 
sensitive measure used in populations that have PTSD. The DAR will be completed in pen 
and paper format by the study participant. It takes approximately 5 minutes to complete.   
 
• Non-VA Healthcare Utilization (Non-VA Inpatient Care and Non-VA Outpatient Care): 
Non-VA Healthcare Utilization will be assessed using the “HERC non-VA utilization 
survey.”  This survey was created in 2011 by VA Health Economics Resource Center 
(HERC) investigators.  The HERC non-VA utilization survey is self-administered and asks 
about outpatient and inpatient (including Emergency Department) visits to non-VA 
providers.  Inpatient visits are characterized by hospital name, location, length of stay, and 
type of hospital (e.g., general medical, nursing home, psychiatric, or substance abuse facility, 
etc.). S survey items regarding time spent receiving paid or unpaid caregiving will be omitted 
because they are outside of the scope of this analysis. The Non-VA Healthcare Utilization 
form will be completed in interview format. It takes approximately 10 minutes to complete.  
 
• Employment/Productivity: Participants’ employment status and work productivity will be 
assessed through the Work Productivity and Activity Impairment Questionnaire: General 
Health Problem V2.0 (WPAI:GHP). The WPAI is the most frequently-used instrument to 
assess work productivity (Prasad et al., 2004).  The WPAI: GHP is a 6-item questionnaire 
that can be interviewer-administered or completed by a respondent (Reilly et al., 1993).  The 
questionnaire asks about the number of hours of work missed due to health problems as well 
as the effect of the health problems on productivity while at work. The 
Employment/Productivity form will be completed in interview format. It takes approximately 
5 minutes to complete.   
 
• Medication Log:  A medication log will be completed for the participant listing all Non-VA 
prescribed medications (prescription and over the counter) that the participant is currently 
taken or has taken for 30 days prior to informed consent.  At every visit during the study, this 
medication log will be updated with current medication information. The Medication log will 
be completed in interview format. Completion time varies. 
 
• Exit Interview: an exit interview will be administered to obtain details related to participant 
perceptions of being paired with a study dog. There are two version of the exit interview: one 
for use with participants who had an emotional support dog, and one for participants who had 
a service dog.  Content includes questions about the overall impact of the study dog on their 
PTSD and mental health symptoms, public access experiences, social outings, impact on 

 
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friends and family, and daily living activities.  Additionally, participants will be asked about 
the usefulness of specific training behaviors of their assigned dogs, reasoning for keeping or 
returning their study dog at the end of the study, obstacles to having a service or emotional 
support dog, and past experiences with owning a service dog.  Open-ended questions are 
included throughout the interview in order to elicit additional details related to their overall 
experiences. Study related experiences relevant to the content of the Exit Interview, that are 
reported by participants prior to administering the Exit Interview, can be documented by 
study staff. This additional information will be included with the Exit Interview at the end of 
the study. 
 
• Suitability to Have a Dog Checklist: A home assessment checklist to assess suitability of the 
home environment for dog placement. The checklist documents availability of space for dog 
to play, availability of space for toileting of dog, the presence of other pets in the home, and 
cleanliness and safety of the home. The measure was developed specifically for this study 
because no other such measure exists. 
 
 
• Screening Phase 
 
1. 
Preliminary Screening: 
 Prior to scheduling a potential participant for a clinic qualifying visit the potential 
participant’s chart notes will be examined to determine whether there are indications that 
the potential participant is ineligible for the study and whether he/she has ongoing mental 
health treatment at VA.  
 A telephone screening will be completed to assess eligibility and thoroughly explain the 
study procedures.  
 A referral letter from mental health provider will be obtained, or confirmation that a 
signed referral letter will be available by clinic qualifying visit will be obtained.  
 In order to help manage expectations, potential participants should be informed that the 
screening phase is an ongoing process and that final eligibility will not be determined 
until the successful completion of the dog Placement or Pairing process. 
 
If any CPRS note, the telephone screen, or other information indicates a potential participant is 
ineligible, the LSI or a designated member of the study team will inform the individual that they 
cannot participate in the study.  
 
 
2. 
Activities prior to Clinic Qualifying Visit. 
 If a signed referral checklist has not been received from a mental health provider in 
advance of the scheduled Clinic Qualifying visit, a member of the study team must 
confirm by telephone prior to the visit that the potential participant will be bringing it in 
person to the appointment. If confirmation is not received, the Clinic Qualifying visit 
must be rescheduled.  

 
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 A member of the study team will make a reminder call to the potential participant. If 
applicable, the potential participant will be reminded to bring the signed referral checklist 
to the appointment.   
 
 
3. 
Clinic Qualifying Visit at VA study site.  
 Informed consent and HIPAA authorization will be obtained.  
 If not already received, the referral checklist/letter will be collected. 
 The Demographic interview and CAPS will be completed 
 The C-SSRS will be administered using the ‘during the last month’ time frame.  
 If the participant meets the screening criteria for the CAPS, the MINI will be completed. 
 If the individual meets CAPS and MINI inclusion criteria he/she will be provided with 
the Home Suitability Guide.  
 The participant will be informed that secondary contact information for an emergency 
contact and dog caretaker will be collected no later than the Home Clearing Visit in order 
to be eligible for the pairing process.  
 Veteran will be paid $25.00 for this first Screening Visit. 
 
  
4. 
Home Qualifying Visit and Baseline Assessments 
If the individual meets the Clinic Qualifying visit criteria, a home visit will be scheduled within 
3 weeks of the Clinic Qualifying visit, unless holiday schedules or an unusual circumstance such 
as veteran illness prevents the visit within that time frame. In such circumstances, the home visit 
will be completed as soon as possible. The home visit is conducted to ensure that the potential 
participant’s home environment is suitable for a dog. The visit will be conducted by one of the 
study dog trainers and another member of the study team.    
 All individuals who reside at the home should be present during the visit if possible. They 
will be asked whether they are willing to have a dog in their home and be responsible for 
the dog in the long-term absence of the potential participant (e.g. if individual was 
admitted to the hospital).   
 It will be emphasized to potential participants that they should at minimum maintain a 
residence in the same locality but ideally should stay in the same home throughout the 
enrollment period because of the necessity to conduct home visits throughout. If a 
potential participant changes residence while enrolled in the study, he/she must be 
informed that the new home must be suitable for a dog and that the new home must be 
geographically and structurally accessible to the study team.  
 The “Suitability to Have a Dog Checklist” will be used to assess the home environment.  
 If needed, the participant will be provided with information to share with their 
homeowners association and/or rental agency regarding the allowance of having a dog in 
their home. This information includes the rights of Emotional Support Dogs protected 
under the Department of Justice fair housing and Service Dogs protected under the 
American with Disabilities Act.  
 Participants will be encouraged to ensure that their home owner/rental insurance policy 
includes a dog.  

 
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• If the home is deemed suitable or only minor modifications are required, baseline 
assessments will be completed.  
• If the home is deemed unsuitable for a dog, the potential participant will be given 
a detailed list of corrections needed, a second home qualifying visit will be 
scheduled, and Baseline assessment will NOT be completed. At that visit, if the 
home is now deemed suitable for a dog, baseline assessments will be completed. 
If still unsuitable the participant may be ineligible to continue in the study.  
However, exceptions can be made at the discretion of the dog trainer. 
 
The following baseline assessments will be administered:  
1. WHODAS 2.0.   
2. PCL5 
3. PSQI  
4. VR-12 
5. PHQ-9  
6. DAR 
7. HERC non-VA utilization survey  
8. WPAI:GHP 
9. Medication Log (initial interview covers medications taken 30 days prior to the Clinic 
Qualifying visit up to the date of the current visit.)  
 
Additional visit-related information and activities: 
• Participants will receive $10.00 for their time and effort.  
• Secondary  contact information (full name, phone number(s), address, and relationship to 
the participant): if contact information has already been collected verify with the 
participant that the information has not changed.  If not already collected obtain the 
information or remind the participant to provide the information prior to the pairing 
process. 
 
 
 
The day on which the Baseline visit is completed initiates day one of the observation phase.    
 
• Observation Phase 
The Observation Phase will last a minimum of three months.  It will end once a dog becomes 
available.  During this phase:   
 
Participants will complete a Dog Care Course  
 Course content will include discussion of: 
• Health issues and when to seek medical attention 
• General care and feeding of dogs (grooming, food, water, exercise, etc.) 
• Recognition and prevention of dog aggression 

 
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• Differences between Service Dogs and Emotional Support Dogs Legal rights of 
Service Dogs and Emotional Support Dogs (ADA, FHA, ACAA) 
• Financial burden associated with  having a dog both during and after the study 
 

 
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VIII. RANDOMIZATION 
 
• Randomization 
Once the participant passes the home evaluation and eligibility check, the participant will be 
randomized using the CSPCC telephone randomization system.  During this call, the participant 
will be randomized to a dog type (SERV or EMOT). Randomization will utilize a random block 
scheme. At this point, vendor, participant, and site are blinded to the intervention group (SERV 
or EMOT) to which the participant is randomized. After randomization, a vendor will be 
assigned based on dog availability. The site will be informed of the assigned vendor and will 
provide the participant with the vendor’s contact information. It will be the participant’s 
responsibility to contact the vendor within two weeks of receipt of contact information. The 
vendor then has 2 weeks in which to interview the participant so that an appropriate dog match 
can be made. This interview should take no more than three hours.  
 
The participant and vendor remain blinded to group to which participant is randomized. 
Following the interview, the vendor and participant may not interact further without the specific 
approval of the study team. If vendor needs additional information from participant, they will 
contact the contracting officer’s representatives (CORs) for appropriate protocol. Vendor will be 
unblinded to the group to which participant is randomized immediately after the interview has 
been completed, but neither the participant nor site will be unblinded until successful completion 
of the Home Clearing visit. There will be a minimum period of 3 months between interview and 
dog pairing. If at 6-months post-interview no dog is available in the foreseeable future, the 
participant may be assigned to a new vendor. In these cases the participant will be interviewed 
by the new vendor and the observation period may start over.   Vendor selection will be made 
based upon current and pending dog availability and expected dog delivery schedules dictated by 
contracts. 
 
If a vendor has concerns about a participant’s appropriateness for a dog/study participation, the 
vendor will contact VA contract personnel (not the Veteran), who will communicate with study 
team members to discuss the issue and if necessary inform the participant.  
 
The vendor will store paper copies of the participant’s information in a secure space and locked 
file cabinet. Only the employees of the vendor who have completed the VA requirements for 
data security (TMS classes) and background checks will have access. This information will be 
included in the Statement of Work (SOW) to which the vendors respond. Should the vendor 
obtain computer capabilities that meet the standards of the VA, then data may be stored on their 
computer. 
 
• Baseline 2 and Home Clearing Visits.  
  
The Baseline 2 and Home Clearing visits will be scheduled to occur once a dog becomes 
available but at a minimum of three months after the Baseline visit.  
 
Baseline 2 Visit:  will take place in the clinic. The following assessments will be completed: 

 
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1. WHODAS 2.0.   
2. PCL5 
3. C-SSRS 
4. PSQI  
5. VR-12 
6. PHQ-9  
7. DAR 
8. HERC non-VA utilization survey  
9. WPAI:GHP 
10. Medication Log  
11. Dog Knowledge Test 
 
Additional visit-related activities and information:  
• Participants will receive $25.00 for this home visit.  
• Secondary contact information (full name, phone number(s), address, and relationship to 
the participant): if contact information has already been collected verify accuracy of the 
information provided by the participant. If not already collected obtain the information or 
remind the participant to provide the information prior to the pairing process. 
• If children between the ages of 5 and 10 years reside in the home provide the AVMA 
family education form.  
 
The Home Clearing Visit:  will take place at participant’s home. This visit is conducted to 
confirm that the participant’s home remains suitable for a dog. At the Home Clearing visit the 
following will occur:  
• The Suitability to Have a Dog Checklist will be re-administered.  
• Review of the DOG course and, if the participant did not pass the Dog Knowledge test 
(score ≥ 80%), provide further education to ensure the participant is aware of the 
responsibilities and obligations of dog ownership. 
• Veterinary Checklist packet can be provided at this visit or at the week 1 post pairing 
visit. This decision will be based on the discretion of the local study team. 
• Collect or verify secondary contact information (full name, phone number(s), address, 
and relationship to the participant).  
• Once a study dog trainer considers the participant has sufficient knowledge and the home 
is confirmed to be suitable for a dog, the participant will be unblinded to the type of dog 
(SERV vs. EMOT) to which they were randomized and will be provided with vendor 
contact information. 
• Review study requirements and expectations that follow the completion of the Home 
Clearing visit and pairing process. 
 
If randomized to the Service Dog group, the vendor will contact the participant  to coordinate 
travel. It should be explained to participants that: 
• They will travel to the vendor’s location for training to become a service dog handler. 
• Training can last several weeks, though in most cases it will last between 1-2 weeks.  

 
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• The pairing process will cover basic obedience commands, execution of the specific 
trained tasks, basic dog care, and the public access rights given Service Dogs by the 
ADA. The participant can request an overview of the training class and ask questions as 
needed. 
• Travel to and from the vendor’s facility may be completed by air or personal vehicle.  
• Reimbursement for use of a personal vehicle will at the government mileage rate paid on 
return from training.  
• To avoid out-of-pocket expenses, the vendor will pay for air travel (and will later be 
reimbursed by VA).  
• Out-of-pocket expenses may be unavoidable in some circumstances. In this instance, 
participants will be reimbursed by VA for expenses allowed by Federal Travel 
Regulations in a timely manner.  
• The vendor will provide accommodation during the training session.  
• The vendor will provide food or reimburse food expenses during the training. 
• ADA Service Dog Public Access Rights pocket card. 
 
Expenses for accommodations are included as part of the Statement of Work (SOW) for the 
Vendor contract. Vendors will provide food or reimburse food expenses for participants while 
they are at the Service Dog pairing visit, using the government per diem rate for that locale. The 
vendor will invoice the VA for the expense as dictated by the contract SOW. 
 
If randomized to the Emotional Support Dog group, the participant will work with local dog 
trainer to receive their dog and dog training. It should be explained to participants that: 
• The local dog trainer will train the participant how to handle his/her dog 
• The training will take place in the participant’s home and local vicinity 
• The training will last between 1 and 2 days.   
• Additional training visits can be scheduled as needed.  
• On completion of training, the dog trainer will provide the participant with a list of 
important phone numbers (probably printed on a refrigerator magnet).  
• An emotional support dog ID card, with the name and picture of the assigned dog, and a 
brief summary of the dog’s right under US law on the back of the card. 
• If applicable a letter signed by the LSI establishing the right of an emotional support dog 
to live in housing where pets are not allowed. 
• If applicable a letter signed by the LSI establishing the right of an emotional support dog 
to fly in the cabin with the participant for commercial air travel. 

 
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IX. 
TREATMENT REGIMENS 
For this section, the following terms are defined: 
 
• Participant:  A Veteran who has been enrolled in the study. 
• VA Dog Trainer:  A person employed by the VA with special skills and knowledge about 
training dogs.  Each VA research site has a “Local” VA Dog Trainer assigned to assist 
the participants at that site with any problems they may experience after they receive 
either a Service Dog or an Emotional Support Dog.  A “National” VA Dog Trainer 
(based in Atlanta) has been hired to supervise the Local VA Dog Trainers and coordinate 
their efforts. 
• Handler:  A term used to denote a participant who has learned or is learning to give 
commands to either a Service Dog or an Emotional Support Dog. 
• Pairing:  The training process in which a handler is given instruction and practice in 
commanding and caring for a Service Dog.  The pairing process takes place at one of the 
dog vendors under contract to provide dogs for the study.  
• Placement:  The process in which a handler is trained to command and care for an 
Emotional Support Dog.  The placement process takes place at the handler’s home, and is 
supervised by a VA Dog Trainer.    
 
• Service Dogs and Emotional Support Dogs 
There are two randomization arms. Veterans will receive either a Service Dog or an Emotional 
Support Dog.  In short, a Service Dog is an assistance dog trained to perform tasks that 
specifically address a person’s disability, and it has public access privileges per the Americans 
with Disabilities Act (ADA) administered by the Department of Justice. In contrast, an 
Emotional Support Dog helps person with a disability by providing companionship or emotional 
support, but is not trained to perform specific tasks to address a disability, and public access 
rights are restricted to commercial air transport.  All dogs will be proofed (tested against contract 
standards) by the National VA Dog Trainer or designee to verify that the dogs meet all 
behavioral, obedience, and training contract standards. 
 
Service Dogs (SERV).  A Service Dog must be well behaved at all times and promptly respond 
to commands (verbal or hand signals) given by the handler. To be effective in the trained tasks, a 
Service Dog must exhibit a strong desire to please the handler and remain at the handler’s side, 
unless otherwise directed.  They must be well socialized to people and other animals.  Per the 
contract in place with the vendors, as part of Service Dogs must  pass the AKC Canine Good 
Citizen (CGC) examination, Assistance Dogs International (ADI) Public Access Test (PAT), and 
also demonstrate the 5 tasks specified by the contract (Lights, Sweep, Bring, Block, and Behind).   
 
Emotional Support Dogs (EMOT).  Emotional support dogs must also be well behaved at all 
times, and well socialized to people and other animals. However, they are not taught specific 
tasks that address disabilities associated with PTSD.  Emotional Support Dogs must pass the 
AKC Canine Good Citizen and AKC Community Canine examinations during the proofing 
process.   
 

 
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Once an Emotional Support Dog is proofed against contract standards, it will be shipped to the 
designated VA study site by the vendor, then kenneled until arrangements can be made by the 
local study coordinator or designee to place the dog with a participant.   
 
In contrast to the 1-2 week pairing process for Service Dogs conducted at a contract vendor’s 
property, a participant randomized to receive an Emotional Support Dog will undergo a 1-2 day 
“placement” process at their home, conducted by a VA Dog Trainer.   As part of the placement 
process, handlers will be reminded about the definition of an Emotional Support Dog, the 
allowances regarding reasonable accommodation for housing, and provided necessary letters if 
required.  The handler will also be shown and then be asked to demonstrate obedience 
commands taught to the dog.  The VA Dog Trainer will also go over care of the dog and make 
sure the house is ready for the dog. 
 
• Contract Training Requirements for All Dogs 
During the proofing process, the National VA Dog Trainer, a Local VA Dog Trainer, a VA 
Veterinarian, or another VA employee serving on the proofing team will fill all roles specified in 
the testing process.  Note that the proofing process will always be conducted at a vendor’s 
property. 
 
Basic Obedience: All dogs will be trained in basic obedience which includes commands for sit, 
down, heel, come, and stay.  These commands help the participant control the dog and help the 
dog learn self-control.  Mastery of basic obedience commands becomes the foundation for 
successful completion of the AKC Canine Good Citizen (CGC) test, which both Service Dogs 
and Emotional Support Dogs must pass.   CGC certification indicates that the dog has 
demonstrated the ability to be well mannered in the home, public settings, and the presence of 
other dogs. 
 
Canine Good Citizen test (AKC, 2013).  Per the VA contract with vendors that provide dogs 
for the study, all dogs must pass the Canine Good Citizen test before acceptance by VA.   
Test 1: Accepting a friendly stranger:  The dog should allow a stranger to approach and speak 
to the handler.  A stranger will approach the dog and greet the handler in a friendly manner.  The 
dog should be ignored by both the trainer and handler at this time. The stranger and handler 
should shake hands and greet each other. The dog should not show signs of jealousy or shyness, 
and should not break position or seek attention from the stranger. 
Test 2: Sitting politely for petting: The dog should allow a friendly stranger to touch or pet it 
while in everyday situations with the handler.  The dog should sit in heel position while the 
stranger pets the dog.  The stranger should touch the dog on the head and body. The handler can 
talk to the dog during this test.  The dog should not show jealousy or shyness, and should not 
break position unless given a command by the handler. 
Test 3: Appearance and grooming: Dogs need to be evaluated to ensure they will allow 
grooming and examination by someone like a groomer, veterinarian, or friend of the handler (the 
“stranger”).  A stranger will inspect the dog for cleanliness and grooming, as well to see if the 

 
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dog appears to be healthy (proper weight, clean, alert).  The stranger will softly brush the dog 
and examine the ears and feet, using equipment provided by the vendor. The dog does not have 
to hold a certain position during the examination. The handler can talk to the dog and offer praise 
during the exercise. 
Test 4: Out for a walk (walking on a loose lead): This test shows that the handler is in control 
of the dog. The dog can walk on either side of the handler. The handler should be able to readily 
see that the dog is attentive and is responding to the handler's movements and changes of 
direction. The dog does not have to be aligned exactly with the handler and does not have to sit 
when the handler stops.   A pre-determined course may be used or the handler can conduct the 
test spontaneously using commands. Either way, there needs to be a right turn, left turn, and an 
about turn with at least one stop in between and another at the end. The handler can talk to the 
dog, offer praise, or give commands in a normal tone of voice. If the handler chooses, he/she can 
have the dog sit at the halts. 
Test 5: Walking through a crowd: A dog should be able to move politely through pedestrian 
traffic and should be under control in public places. The dog and handler will navigate around 
and pass close to at least three people. The dog may show transient interest in the strangers, but 
should walk with the handler without showing excitement, shyness, or jealousy. The handler may 
talk to the dog and/or give encouragement or praise during this test. The dog should not jump on 
people in the crowd or pull on the leash. 
Test 6: Sit and down on command and staying in place: The dog should be able to 
demonstrate that it has been trained to respond to the handler’s commands, including sit and 
down, and that it can remain in position until released by the handler. The dog should 
demonstrate sit AND down on command, then the handler chooses the position for leaving the 
dog in the stay. Before performing this exercise, the dog's leash is replaced with a lead 20 feet 
long. The handler can take a reasonable amount of time and use more than one command to get 
the dog to sit and then down. The proofing team will determine if the dog has responded to the 
handler's commands appropriately. The handler cannot force the dog into position, but can touch 
the dog to offer encouragement.  The handler will then tell the dog to stay and the handler will 
walk forward the length of the line (20 ft.).  The handler will then turn and return to the dog at a 
natural pace. The dog should stay where it was left (it may change position) until the handler 
releases the dog. The dog may be released from the front or the side. 
Test 7: Coming when called: The dog should come when called by the handler. The handler 
will walk 10 feet away from the dog, turn to face the dog, and call the dog. The handler can 
encourage the dog to get the dog to come. A dog can be told to "stay" or "wait" if the handler 
chooses.  The handler can also simply walk away, giving no instructions to the dog. 
Test 8: Reaction to another dog: The dog should be well behaved around other dogs. Two 
handlers and their dogs will approach each other from a distance of about 20 feet, stop, shake 
hands and greet each other, then continue on for about 10 feet. The dogs should only show 
transient interest in each other. Neither dog should seek attention from the  other dog or its 
handler. 

 
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Test 9: Reaction to distraction: The dog should be confident at all times when placed in 
common distracting situations. Two distractions will be used. Distractions can be things like 
dropping a chair, rolling a crate dolly past the dog, having a jogger run in front of the dog, or 
dropping a crutch or cane. The dog may show casual interest or curiosity and/or may appear 
slightly startled.  The dog should not panic, try to run away, show aggression, or bark. The 
handler can talk to the dog, encourage or praise it throughout the exercise. 
Test 10: Supervised separation: The dog should demonstrate that it can be left with a trusted 
person, if necessary, and will maintain training and good manners. One of the proofing team 
members will say something like, "Would you like me to watch your dog?" and then take hold of 
the dog's leash. The handler will go out of sight for three minutes. The dog does is not expected 
to stay in position, but it should not continually bark, whine, pace unnecessarily, or show 
anything stronger than mild agitation or nervousness. The proofing team member can talk to the 
dog but should not engage in excessive talking, petting, or other management attempts. 
Equipment:  A leash must be used for all tests. Dogs should wear well-fitting buckle or slip 
collars made of leather, fabric, or chain.  
Encouragement: Praise and encouragement can be used by handlers to the dogs throughout 
the test. Petting can also be used between exercises. Handlers may not use food or treats 
during testing.  Toys, squeaky toys, etc. may not be used in order to get the dog to do 
something.  
Failures – Dismissals: Dogs will be disqualified for eliminating during testing. Any dog that 
shows aggressive behavior such as growling, snapping, biting, attacking, or attempting to 
attack will be disqualified. 
• Emotional Support Dog Specific Training 
All Emotional Support Dogs will pass the AKC Community Canine test (AKC, 2013). The AKC 
Community Canine test is the advanced level of the AKC’s Canine Good Citizen Program. The 
AKC Community Canine test is intended to be administered in situations more realistic than a 
show dog ring.   
Test 1. Dog stands, sits or lies down and waits under control while the owner:  The dog sits 
at the registration table and waits under the control of the handler while the handler fills out 
paperwork, or, if the test is done in the community, dog waits while the handler sits and has a 
snack or visits with another person (e.g., at a park).  The length of time for this exercise should 
be about 3 minutes.  
Test 2. Walks on a loose leash in a natural situation (not in a ring)–does not pull:  This test 
is the same as described above in the Canine Good Citizen test, except that it is done in a natural 
situation (i.e., community and not a ring) and the dog does not pull.  The test should include at a 
minimum a left turn, right turn, stop and fast and slow pace. 

 
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Test 3. Walks on loose leash through a crowd:  A dog should be able to move politely through 
pedestrian traffic and should be under control in public places. The dog may show transient 
interest in strangers, but should walk with the handler without showing excitement, shyness, or 
jealousy. The handler may talk to the dog and/or give encouragement or praise during this test. 
The dog should not jump on people in the crowd or pull on the leash.  This test should be 
conducted at a show or in class (not in a ring) or in the community, dog walks on sidewalk, 
through a crowd at a community fair, park, on a trail, through a busy hallway, etc. 
Test 4. Dog walks past distraction dogs present; does not pull:  This item may be tested along 
with #3 if there are dogs in the crowd, etc.  The dog should be well behaved around other dogs.  
This test can be conducted at a show or class where the dog walks by dogs waiting in the crowd 
(dogs 2 ft. apart) or in the community where the dog walks by other dogs on a trail, sidewalk, in 
a hallway, etc. 
Test 5. Sit–stay in small group (3 other people with dogs):  The purpose of this exercise is to 
test the dog’s ability to be under control when in close proximity to other dogs. The exercise 
begins with the dog sitting at the handler’s left side on a least about 3 feet apart.  Handlers and 
dogs are in an informal circle/square while handlers have a conversation.  As the handlers engage 
in informal conversation, dogs are permitted to change position. They are not penalized for lying 
down or standing, as long as they remain under control and do not move to go to other dogs. This 
exercise simulates waiting for an elevator, getting together to plan a hike, debriefing after a 
therapy visit, etc.  
Test 6. Dog allows person who is carrying something (backpack, computer bag, etc.) to 
approach and pet it:  A VA proofing team member asks "May I pet your dog?" (Item is placed 
on floor/ground before the person pets the dog).  The item can be placed 2-3 ft. from the dog. 
Dogs should not shy away from the bag, nor should they lunge toward it and put their heads 
inside.   
Test 7. "Leave it.":  Dog walks by food and follows handler instructions to "Leave it."  The 
food should be placed 2-3 feet away from the dog.  This can be food placed by the evaluator on 
the floor or ground in a food dish with a wire cover as in Rally.  The dog is walked by the food 
and should not lunge toward it. 
Test 8. Down or sit stay–distance (owner's choice):  The dog should be able to demonstrate 
that it has been trained to respond to the handler’s commands, including sit or down, and that it 
can remain in position until released by the handler.  The dog is placed on a 20–ft. line and the 
owner walks away with their back to dog, picks up an item (e.g., backpack, training bag, 
clipboard, folder etc.) placed on the floor/chair/ground by the evaluator and returns to the dog.  
The handler returns to the dog and gives the item to another VA proofing team member. 
Test 9. Recall with distractions present (coming when called): The dog should come when 
called by the handler.  The handler goes out 20–feet (off center) and calls dog.  The dog is on the 
20–ft. line from #8 above.  Examples of distractions include another person, a stack of boxes, or 

 
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a chair with a shopping bag on it.  The distraction should be placed as below.  The dog should 
come to the handler when called. 
 
Test 10. Dog will sit or stand stay (handler's choice) while owner enters/exits a doorway or 
narrow passageway. Handler calls dog through door when ready:  Handler may also choose 
to 1) send the dog through first and have the dog wait for the owner, or 2) the handler may 
choose to have the dog go through the doorway at the handler's side. Whichever method is used, 
the dog must not pull the handler and must be under good control. Think of the handler having 
the leash in one hand and a cup of coffee in the other.  The doorway or gate can be real or 
simulated with ring gates, two chairs, or a natural passageway (e.g., entrance to trail) in the 
community. 
 
• Service Dog Specific Training 
If a command is too close in pronunciation to a command routinely taught to dogs by the 
vendor, the vendor may request that another command name be substituted for the command 
names below.  
 
1. 
PTSD Specific Tasks 
 
Block (stand in front of Veteran to give space).  VA proofing team members will evaluate the 
ability of the dog to provide physical space in front of the handler. The dog should perform 
the task reliably each time and should not have to be given a command more than three times 
before complying. 
  
• This task shall be demonstrated in a public place.  The handler will walk with the dog 
for at least 30 feet distance then and stop.  The dog should naturally stop with the 
handler.  As a VA proofing team member approaches from the front, the block 
command will be given.  The dog should step in front of the handler to provide a 
physical barrier between the handler and the person approaching.   
• The dog should be relaxed and not exhibit aggressive, defensive, or protective 
behaviors.  The dog should not show interest in the person approaching and should 
stay in block position until released by the handler with an appropriate command.  
 
Lights (locates and turns on lights )  The dog will be tested on its ability to enter a room 
ahead of the handler and turn on the lights to ensure good visibility, reduce the risk of falls, 
and generally make the handler feel more at ease. This is a task that will be ultimately 
performed in the participant’s home, and should be demonstrated in a home or simulated 

 
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home environment. A standard consumer light switch must be used (touch plates or similar 
adaptive hardware are not acceptable). 
 
• To demonstrate the skill, the handler will walk the dog to a door or entryway and give 
the command, “lights.”  The dog should enter the room and turn on a light while the 
handler remains in the entryway.     
• Once the lights are on, the dog will return to the handler’s side and wait for further 
direction.  
 
Sweep (room, perimeter, turn on lights, if needed).  The dog will be tested on its ability  to 
enter a room ahead of the handler and sweep the perimeter of a room.  The dog should 
perform this task reliably each time and should not have to be given a command more than 3 
times before complying.  The dog must bark if a “stranger” is detected.  This is a task that 
will be performed in the subject’s home and should be demonstrated in a home or simulated 
home environment.   
 
• To demonstrate the skill, the handler will walk the dog to a door or entryway. A 
command will then be given for the dog to do a sweep of the room.   
• Once it is established that the room is clear, the dog will return to the handler’s side.   
• If the dog detects someone in the room it will alert the handler by barking. 
 
Bring (retrieves an object at the request of the handler).  Dogs will be tested on their 
ability to bring specified items to the handler upon request.  The dog should perform the task 
reliably each time and should not have to be given a command more than three times before 
responding. This task may be applicable to both the home and public environments.  
 
• To demonstrate the skill, the handler points to a specific object and gives the 
command.   If the specified object is in a group of objects, the handler will say the 
name of the object in combination with the handler pointing to the object.   
• Once the dog correctly locates the specified object, the dog carries the object to the 
handler and releases the object to the handler.   
 
Behind (stand behind handler to give space).  The dog will be tested on its ability to provide 
physical space behind the handler.  The dog should perform the task reliably each time and 
should not have to be given a command more than 3 times before complying.   
 
• This task should be demonstrated in a public place.  The handler will walk with the 
dog for at least 30 feet then stop.  The dog should naturally stop with the handler.  
The dog will be given the “behind” command and the dog should step behind the 
handler to provide a physical barrier behind the handler.  The dog should stay in 
“behind” position until released by the handler.   
• The dog should not exhibit aggressive, protective, or defensive behaviors.  
• The dog should be alert but not show interest in or seek attention from the people 
behind the handler.  

 
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2. 
Public Access Test (ADI, Public Access test, 2013)  
 
Controlled unload out of vehicle: At a location chosen by the VA proofing team, the 
handler unloads the dog from the vehicle. The dog should not exit the vehicle until the 
handler releases it.  Once outside, the dog should wait quietly for further instruction from 
the handler. The dog may not run around, be off lead, or ignore commands given by the 
handler.   Once the handler and dog are out of the vehicle and settled, another VA proofing 
team member should walk past (within six feet) with another dog.  The Service Dog should 
be calm and controlled.  The dog should not pull or be distracted by the other dog.  The 
Service Dog should remain unobtrusive and exit a vehicle in a manner that is safe for both 
the dog and handler.  
 
Approaching a building: After exiting the vehicle, the handler and dog must get through a 
parking lot and approach a building. The dog must stay in a heel position and cannot pull 
ahead or lag behind. The dog should not show fear toward cars or traffic.  It should be 
relaxed and calm.  Any time the handler stops, the dog should naturally stop.  
 
Controlled entry through a doorway: The handler may enter a doorway in whatever 
manner they prefer, as long as it is safe.  Once inside the building the dog should not 
attempt to wander, or seek attention from others. The dog should calmly walk beside the 
individual. The dog should not pull or try to push its way past the handler.  It should remain 
calm and patient while entry is completed. 
 
Heeling through the building: Once inside the building, the handler and the dog should 
walk together in a controlled manner. The dog should always be within touching distance or 
no greater than a foot away from the handler. The dog should not seek attention from others 
or pull ahead. The dog should readily adjust to speed changes, turn corners promptly, 
and  move through a crowded area without being distracted or seeking attention. In small 
spaces, the dog should be able to navigate around obstacles and not knock things over.  The 
dog should not attempt to pick up or play with merchandise.   
 
Six foot recall on lead: In a large, open area the handler will perform a six foot recall with 
the dog remaining on lead. The handler will sit the dog, tell it to stay, travel six feet, then 
turn and call the dog. The dog should react quickly and not stop for attention from other 
persons or ignore the command. The dog should come close enough to other persons to be 
readily touched. The recall should be smooth and deliberate without the dog stopping or 
pausing along the way.  
 
Sits on command: The dog will be tested on  its ability to sit three different times with 
distractions. The dog should respond quickly each time and should not need to be given a 
command more than twice.  Normal, reasonable behavior on the part of other persons in the 
area is expected.  No extraordinary measures should be taken by other persons to elicit a 
response from a dog. 

 
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The first sit will be next to a plate of food placed on the ground. The dog should not attempt 
to eat or sniff the food. The handler can correct the dog away from the food, but then the 
dog must maintain a sit and ignore the food. The dog should not be taunted or teased with 
the food. This situation should be made as realistic as possible. 
 
The second sit will use a VA proofing team member with a shopping cart, stroller, or 
wheelchair.  The VA proofing team member will approach within three feet of the dog and 
walk by. The dog should remain in the sit position and not show any fear of the equipment. 
If the dog starts to move, the handler can correct the dog to maintain the sit. 
 
The last sit will be a sit and stay as a VA proofing team member walks up behind the dog 
and handler, talks to the handler, and then pets the dog. The dog may not break the stay to 
solicit attention. The handler may repeat the stay command along with reasonable physical 
corrections. 
 
Down on command: The down command will be done in the same manner as the sit using 
the same basic guidelines. The first down will be at a table where food will be dropped on 
the floor (see below for restaurant). The dog should not break position to eat or sniff the 
food. The handler may give verbal and/or physical corrections to maintain the 
down.  Normal, reasonable behavior on the part of the assistants is expected.  No 
extraordinary measures should be taken by assistants to elicit a response from a dog. 
 
The second down will utilize an adult and child to approach the dog while in the down 
position. The dog should maintain the down and not solicit attention. If the child pets the 
dog, the dog should remain calm and controlled, and should not break the down position. 
The handler may give verbal and physical corrections if the dog begins to break position.  
 
Noise distraction: The handler will walk with the dog in heel position and another VA 
proofing team member will drop a clipboard on the ground behind the handler and dog. The 
dog may acknowledge the noise, but should not show aggression or fear, shaking, etc. A 
normal startle reaction is fine (the dog may jump and/or turn) but the dog should quickly 
recover and continue in heel position.  
 
Restaurant: The dog and handler will be seated at a table in a restaurant. The dog should 
go under the table unless size or space doesn’t allow it.  If the dog is unable to go under the 
table, it should lie somewhere near the handler.  The dog should sit or lie down but may 
adjust its position for comfort as needed.  The dog should not be up and down a lot or need 
a lot of correction. This is a good place to test the food drop during a down.  
 
Off lead: In an appropriate place chosen by the VA proofing team, the handler will be 
instructed to drop the leash while moving so that the dog is aware it has been dropped. The 
handler will determine if he/she can maintain control of the dog and get the leash back in its 
appropriate position. The primary focus is that the dog is aware that the leash has been 

 
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dropped and that the handler can maintain control of the dog while the leash is put back into 
proper position.  
 
Controlled unit: The dog and handler will leave the building with the same guidelines for 
entering.  Safety and control of the dog are the main focus. The dog and handler will 
proceed across the parking lot and back to the vehicle. The dog should be in proper heel 
position and it should not show fear of vehicles, people, or traffic sounds. 
 
Controlled load into vehicle: The handler will load the dog into the vehicle. The dog 
should not wander or show distraction.  The dog should wait patiently for instructions. 
Emphasis is on safety and control.  
 
Disqualifying Behaviors.  A dog that displays aggressive behavior (growling, biting, 
raising hackles, showing teeth, etc.) will be disqualified. A dog that eliminates in a building 
or shows uncontrollable behavior (barking, jumping, uncontrolled attention seeking) will be 
disqualified. 
 
 
• Issues related to the dogs: Dog Health and Behavioral Standards for Service Dogs 
and Emotional Support Dogs. 
All dogs purchased by the VA will conform to requirements as set forth by the Statement of 
Work (SOW). In addition to acceptable performance during testing, all candidate dogs must be 
generally attentive toward people, free of anxiety around people and other animals in typical 
daily circumstances, and friendly toward people and other animals.  They must display good 
socialization and be extremely tolerant of people. Any of the following defects in behavior 
displayed at any point during evaluation or consignment may be cause for rejection. This list is 
provided as a helpful guide and example to all persons presenting canines for purchase and is not 
intended to be a complete list or legally binding.  The defects include but are not limited to: 
• Unwillingness to comply or cooperate with handlers 
• Fear, shyness, or nervousness in response to people or being handled 
• Inability to work in proximity to people or other dogs because of aggressiveness 
• Aggression toward handler 
• Fearful or cowering behavior when being loaded or unloaded from a vehicle 
• Excessive panting not due to heat or exercise 
• Sensitivity or fear in response to environmental stimuli, such as public buildings (e.g., 
hospitals, grocery stores, etc.), vehicles, slick surfaces, elevated surfaces, stairs, noisy 
objects, crowds of people, and other stressors/distracters likely to be encountered in 
public places. 
 
• Breed, Sex, Weight, and Height Requirements 
The paragraphs below detail acceptable breeds, physical appearance, and size and weight 
requirements for canines. 

 
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• Breed.  The canines shall be one of the following breeds, unless the study team 
and/or Contracting Officer provide specific approval otherwise: Labrador Retriever, 
Golden Retriever, Labrador Retriever-Golden Retriever cross, German Shepherd, or 
other breeds that fit the specified requirements.   Canines should not weigh less than 
45 pounds or more than 80 pounds.  Canines should not be less than 20 inches at the 
withers. Rationale for using these breeds include: 
o These are the most common breeds used for Working and Service Dogs. 
o They have the physical requirements to perform the tasks to be included in the 
study. 
o Labradors and Golden Retrievers typically like humans. The dog personality 
is outgoing, the dogs are not perceived as threatening by the public, and have 
a lesser tendency to be aggressive. 
o German Shepherds can and do make good working/Service Dogs, and their 
genetics make them fearless, independent, and protective. 
o 
Based on site visits to vendors who provide working and Service Dogs by 
study team members, the dog type that they preferred was consistently the 
Labrador, the Golden Retriever, or Labrador and Golden cross.  However, 
other breeds that fit the specified requirements would be considered and must 
have approval by the study team and contracting officer. 
• Age.  Canines must be at least 16 months, but not more than 24 months of age, at 
time of the evaluation. 
• Sex.  Males and females are acceptable.  All canines will be neutered prior to 
purchase by VA.   
 
• Medical Requirements 
• General Health.  In general, all canines must be in excellent health with no acute or 
chronic disease or condition which could either hamper their ability to perform as a 
Service Dog or Emotional Support Dog, or would be excessively costly to treat or 
manage (>$1,000 per year).  At the time of proofing, each animal must be medically 
sound.  
• Medical Screening of Radiographs of Candidate Service Dogs and Emotional Support 
Dogs.  Vendors must submit proof that an animal has an Orthopedic Foundation for 
Animals score of fair or better on elbow and hip conformation.  Minimum data 
imprinted (“flashed”) permanently on the radiograph at the time of exposure will 
include canine identification (name, tattoo/brand number, and/or microchip number), 
whelping date (or age at time of radiographic examination), and date of examination. 
Radiographs of dogs should be obtained no earlier than  14 months of age. 
• Vendors will provide documentation, which will be reviewed by the COR within the 
time period specified by the SOW. 
• A canine that has been presented once for consideration for purchase and has been 
disqualified for medical reasons may not be resubmitted for consideration unless the 
vendor can document that the medically disqualifying condition has been corrected.  
Other disqualifying issues are listed in the SOW. 
 

 
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• Standards 
• Gait.  All canines must display normal mobility at a walk and run.  Canines are 
disqualified for any gait abnormality, which could affect the canine’s ability to 
perform as a Service or Emotional Support Dog.  
• Skin and Coat.  Skin and coat must be healthy in appearance, displaying no evidence 
of chronic dermatitis, allergies, infections, injuries, or marked external parasite 
infestation (e.g., ticks, mange, fleas, etc.).  A matted, unthrifty hair-coat may not be 
grounds for disqualification but will raise concern about the canine’s general health.   
• Teeth and Jaws.  Canines will have normal dentition and dental occlusion. All four 
canine teeth should be present and must not be weakened by notching, enamel 
hypoplasia, or abnormal, excessive wear.  They should not have more than 1/3 inch of 
the tip missing or have pulp cavity exposed.  Oral infection or excessive periodontal 
disease may be grounds for disqualifying a canine.  Broken teeth or excessively worn 
teeth are disqualifying.  
• Heart and Lungs.  Heart sounds, rate, and rhythm must be normal (e.g., no murmurs, 
arrhythmia, etc.).  In general, the cardiovascular and respiratory system must be 
normal at rest and upon exercise. Current heartworm disease is disqualifying.  
• Limbs and Joints.  Any condition of the bones, joints, or muscles that might hamper 
or restrict the normal performance of Service or Emotional Support Dog duties is 
grounds for disqualification.  Examples include: 
o Hip dysplasia and elbow dysplasia.  A malformation of the hip and elbow 
joints, respectively, which usually results in degenerative joint disease, 
arthritis, and chronic lameness.  Radiographic evidence of hip dysplasia, 
elbow dysplasia, or degenerative joint disease, as determined by licensed 
veterinarian(s) will disqualify a canine. 
o Fractures, which are unhealed, are disqualifying.  Healed fractures resulting in 
significant bone or joint conformation changes or lameness are disqualifying. 
o Ligament damage, osteoarthritis, etc., of the limb joints is generally 
disqualifying. 
o Transitional vertebrae of the caudal lumbar spine, lumbosacral junction, or 
sacrum may be disqualifying.  Asymmetric pelvic attachment is also 
disqualifying.   
• Nervous System and Basic Senses.  Any defect in the nervous system, to include the 
basic senses of vision, hearing, and sense of smell, is disqualifying.  Examples 
include, but are not limited to, opacities of the cornea, eyelid deformities, cataracts, 
retinal degeneration, chronic otitis, acute or chronic rhinitis/sinusitis, and spinal 
disease. 
• Heartworms.  All canines submitted for purchase must be free of heartworm 
infection (Dirofilaria immitis).  A negative heartworm concentration test (filtration or 
Knott’s) is not sufficient evidence to declare the animal heartworm-free. 
• Intestinal Parasitism.  Infection with intestinal parasites (roundworms, hookworms, 
tapeworms, etc.) may not be disqualifying, depending on the level of infection and the 
overall condition of the animal.  Presence of intestinal parasites is, however, an 
indication of poor care and will raise concern about the canine’s general health. 

 
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• External Parasitism.  Presence of fleas, ticks, lice or mange mites may not be 
disqualifying, depending on the amount of infestation, the degree of associated skin 
disease, and the overall condition of the canine.  Presence of external parasites is, 
however, an indication of poor care and will raise concern about the canine’s general 
health.   
• Immunization.  All canines presented must have been vaccinated within the previous 
12 months for rabies, canine distemper, canine adenovirus (TYPE 2), coronavirus, 
parainfluenza, parvovirus, and leptospirosis.  A vaccination certificate with individual 
canine identification (name, procurement number, or microchip #) must be provided 
on all canines.  This facilitates health certificate preparation if the canine is to be 
returned to the vendor. 
• Reproductive and Urinary System.  Any congenital or conformational abnormality 
is disqualifying if the defect requires long-term medical treatment or results in a 
shortened working life of the canine (e.g., cryptorchidism is not disqualifying unless 
the retained testicle results in medical complications not treatable by simple 
orchidectomy.  A juvenile vulva resulting in urine scalding is disqualifying.). 
• Socialization.  All canines presented must be socialized to medical examinations as 
well as people (all ages, sizes, ethnicities, etc.) and to other animals. Poorly socialized 
canines will be rejected.  Rejected canines can be returned for consideration once they 
are properly socialized.  
• Common Medically-Disqualifying Conditions.  The following list is provided as a 
helpful guide and example to all persons presenting canines for purchase and is not 
intended to be a complete list or legally binding.   
o Hematological abnormalities consistent with severe parasitism, infection, or 
metabolic disease. 
o Poor body condition, either emaciation or obesity. 
o Significant periodontal disease. 
o Significant, non-resolving or intractable otitis externa or dermatitis. 
o Radiographic signs of hip or elbow dysplasia or radiographic evidence of 
degenerative joint disease. 
o Previous musculoskeletal injury which has or may lead to degenerative joint 
disease or conformational abnormality. 
o Transitional vertebrae of the caudal lumbar spine, lumbosacral junction, or 
sacrum may be disqualifying, as is the presence of any degenerative change in 
the lumbar spine (such as arthritis).  Asymmetric pelvic attachment may also 
be disqualifying. 
 
• Proofing of Dogs 
Proofing will occur at the vendor location. It will be conducted by the National dog trainer and a 
veterinarian. 
• The vendor will provide a list of medically cleared dogs to the contract COR and VA 
National Dog Trainer (identified by name and microchip #) that respond to commands 
(basic obedience and skilled tasks) given by the handler 90% of the time on the first ask 
in all public and home environments.  

 
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• A veterinarian will review the dogs and medically clear them for use in the study.   
• After the dogs are medically cleared by a VA Veterinarian, the vendor will provide a list 
of these dogs to be evaluated by the VA trainer (proofed). 
o The vendor will provide to the VA National Dog Trainer all training records of 
the dogs to be proofed.  
o The contractor shall have all necessary materials and aids necessary to complete 
the specific tasks, CGC, Community Canine (CGCA) and PAT readily available.   
o All dogs medically cleared at that time will be proofed in one day, if time allows. 
It is estimated that it will take 1-3 hours to proof each dog, depending on the 
number of dogs and type of dogs eligible for proofing.  
• Once dogs are accepted officially, the VA will notify the vendor providing health 
insurance which will include dogs name, microchip information, and other relevant 
characteristics of the dog 
o Once dog is paired, participant’s name will be sent to vendor. 
o Participants will be provided an ID card from the dog wellness/insurance 
contractor to take to their veterinarian so that the veterinarian may bill the 
insurance contractor directly. If the veterinarian’s office does not want to bill the 
contractor, the veterinarian can call the 1-800 number provided on the card and 
get paid via a credit card that day by the contractor. There should be no out-of-
pocket cost for participants unless they request services not covered by the 
insurance.  The list of covered services will be provided to the participants by the 
insurance vendor.  On rare occasion VA may need to reimburse a participant for a 
legitimate expense not covered by the insurance.

 
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X. 
FOLLOW-UP ASSESSMENTS 
 
 
• Pairing Dates: 
The official pairing date for participants paired with Service Dogs is the date they depart from 
the vendor’s facility after training. This should be the same date identified on their training 
completion certificate provided by the designated vendor.   
 
The official pairing date for participants placed with an Emotional Support Dog is the last day of 
training with the VA dog trainer (Local or National Dog Trainer). 
 
Post Pairing Monitoring Visits 
 
• Week 1 post-pairing visit: 
Approximately one week after receipt of the dog, the dog trainer will conduct a home visit at 
which the Post-Pairing Evaluation, the Veteran and Service/Emotional Support Dog Visit Report 
and the Dog Related Questions will be completed. If there is a child living in the home who is 
aged between 5 and 10 years, the dog trainer will evaluate the behavior of the dog when the child 
is present preferably through direct observation. If this is not possible (child at school, or 
elsewhere) the participant will be thoroughly interviewed instead. The participant will be 
provided with a Post-Pairing Survey and postage-paid envelope to compete and mail to a 
member of the study team. The Veterinary Checklist packet (includes form 23) will be provided 
to the participant. If the packet was given during the Home Clearing Visit a reminder will be 
provided for the return of the form or if available will be collected at the time of the visit. 
Provide the participant with a visit timeline calendar. Participants will receive $10 for their time 
and effort. 
.  
 
• Week 2 post-pairing contact: Home visit or telephone call 
Approximately two weeks after receipt of the dog, the participant will be contacted for a second 
time by the dog trainer. If at the week 1 post-pairing visit the dog trainer was satisfied that the 
Veteran and dog had bonded and that there were no concerns, this contact can be completed by 
telephone. If the dog trainer had concerns, this visit will take place in the participant’s home. 
Further, if there is a child living in the home who is aged between 5 and 10 years, a home visit 
will be conducted regardless of the week 1 visit findings. The dog trainer will evaluate the 
behavior of the dog when the child is present preferably through direct observation. If this is not 
possible (child at school, or elsewhere) the participant will be thoroughly interviewed instead. 
Regardless of form of contact, the Dog Related Questions will be completed. If there is a home 
visit, the Veteran and Service/Emotional Support Dog Visit Report will also be completed. 
Participants will receive $10 for their time and effort. 
 

 
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• Month 1 visit:  
Month 1 visit will take place 30 days (±7 days) after receipt of dog. The visit will take place at 
the participant’s home. The Veteran and Service/Emotional Support Dog Visit Report and the 
Dog Related Questions will be completed in interview format. If there is a child living in the 
home who is aged between 5 and 10 years, the dog trainer will evaluate the behavior of the dog 
when the child is present preferably through direct observation. If this is not possible (child at 
school, or elsewhere) the participant will be thoroughly interviewed instead.  Secondary  contact 
information will be verified and the participant will be reminded about the Veterinary Checklist. 
Participants will receive $10 for their time and effort. 
 
• Month 2 contact:  
Month 2 contact will take place 60 days (± 14 days) after receipt of dog.  If at the month 1 post-
pairing visit the dog trainer was satisfied that the Veteran and dog had bonded and that there 
were no concerns, this contact will be by telephone.  If the dog trainer had concerns, this visit 
will take place in the participant’s home. Further, if there is a child living in the home who is 
aged between 5 and 10 years, a home visit will be conducted regardless of the month 1 visit 
findings. The dog trainer will evaluate the behavior of the dog when the child is present 
preferably through direct observation. If this is not possible (child at school, or elsewhere) the 
participant will be thoroughly interviewed instead. Regardless of form of contact, the Dog 
Related Questions will be completed.  If there is a home visit, the Veteran and Service/Emotional 
Support Dog Visit Report will also be completed. The participant will be reminded about the 
Veterinary Checklist if not already received. Participants will receive $10 for their time and 
effort. 
 
Post Pairing Outcome Visits 
 
• Months 3, 9 and 15 clinic visits and associated telephone calls:  
At months 3, 9 and 15 (±14 days) after receipt of dog, the participant will attend a visit at the 
local VA study site. The C-SSRS, HERC non-VA care WPAI, and Medication Log will be 
completed in interview format. The WHO-DAS 2.0, PCL-5, PSQI, VR-12, PHQ-9, and DAR 
will be completed in pen and paper format. Participants will receive $25 for each visit for their 
time and effort. Secondary  contact information will be verified. At Months 03 and 09 the 
participant will be provided with the Veterinary Checklist packet (includes form 23).  Each visit 
will last approximately 2 hours, with the exception of the month 15 visit which will be longer 
due to the additional steps listed below.    
 
Month 15 Visit:   
• CAPS will be administered. 
• Veterinary Checklist packet (includes form 23) will be provided and should be 
completed around 17 Months. 
• Discussions related to keeping or returning the study dog at the end of the study will 
be initiated. 
 

 
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Within approximately 2-weeks of each clinic visit, the dog trainer will telephone the participant 
to complete the Dog Related Questions form.  
 
Preparation for the transfer of dog ownership at the end of the study: Participants will have 
the option of returning or keeping their dog at the end of the study. In order to prepare 
participants for making a choice, study staff will initiate ongoing conversation with the 
participant regarding end-of-study dog placement starting at the Month 15 Visit. Information 
gathered during these interactions will assist in preparing for the transfer of ownership to the 
participant or for return of the study dog, which will include shipment of the dog back to the 
assigned vendor.  
   
• Months 6 and 12 home visits: 
At months 6 and 12 (±14 days) after receipt of dog, the participant will have a home visit from 
members of the study team. The following measures will be completed: The C-SSRS, HERC 
non-VA care, WPAI, WHO-DAS 2.0, PCL-5, PSQI, VR-12, PHQ-9 DAR, Medication Log, 
Veteran and Service/Emotional Support Dog Visit Report, and the Dog Related Questions. 
Secondary contact information will be verified. At Months 06 and 12 the Veterinary Checklist is 
due. Participants will receive $10.00 for their time and effort.  
 
• Month 17: 
Around 17 Months study staff will contact the participant regarding completion of the Veterinary 
Checklist provided to the participant at the 15 month visit. The option of keeping the dog at the 
completion of the study is contingent upon the receipt of this final veterinarian exam.  
 
• Month 18 home visit: 
At months 18 (± 28 days) after receipt of dog, the participant will have a home visit from 
members of the study team. The following assessments will be completed:  C-SSRS, HERC non-
VA care, WPAI, WHO-DAS 2.0, PCL-5, PSQI, VR-12, PHQ-9, DAR, Medication log, Veteran 
and Service/Emotional Support Dog Visit Report, Dog Related Questions, Dog Trainer 
Evaluation form, and Exit Interview (Note: do not re-administer the Exit Interview to 
participants who have already completed the interview following the permanent removal of their 
study dog). Participants will receive $10.00 for their time and effort.  
 
1. 
Transfer of Dog Ownership 
 
At the successful conclusion of the 18 month visit, participants may choose to keep or return 
their study dog.     
 
If the participant chooses to keep his/her dog and the final Veterinary Checklist has NOT been 
completed and returned the participant will be reminded that the final checklist is required prior 
to the official transfer of dog ownership.  The participant will be given approximately 2 weeks to 
complete and return this checklist.  If the exam has already been completed but not returned, 
study staff, including the CVMO in some cases, will work with the participant to retrieve the 

 
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completed checklist. Once the checklist has been returned study staff will need to schedule a 
follow up visit in order to complete the transfer process below. 
If the participant chooses to keep his/her dog and the final Veterinary Checklist has been 
returned to study staff he/she will be: 
• Asked to sign the Transfer of Dog Ownership Verification form and provided with a 
signed copy. 
• Given the Dog Ownership Chip Registry Instructions form. 
• Given the VA Certificate of Study Completion (dog retention version). 
• Given the Dog Care Sheet. 
• Offered a vendor information packet if available. 
• Reminded that neither the study nor the VA will provide further dog care support and 
that care is now his/her total responsibility  
• Provided with the vendor’s contact information and informed that it is now 
permissible to contact the vendor directly to receive any follow up services provided 
by the vendor. Such services may include training support, supplies, support groups, 
or other services; and 
• Informed that it may be necessary to return the dog’s service vest to the vendor if 
vendor conditions for retaining the vest are not met (only applies to participants who 
have a service dog). 
  
If the participant chooses not to keep his/her dog, it will be removed by a study dog trainer in 
order to be transported to the original vendor. Arrangements to have the dog removed will be 
made between study staff and the participant prior to or during the final visit. The participant will 
sign the Transfer of Dog Ownership Verification form and provided with a signed copy. The 
participant will be asked to sign the Transfer of Dog Ownership Verification Form and provided 
with a VA Certificate of Study Completion (dog return version). 
 
Participants who complete the 18 month visit prior to the approval of pertinent forms (i.e., 
Transfer of Dog Ownership Verification form, Dog Ownership Chip Registry Instructions form 
and VA Certificate of Study Completion [dog retention version], etc.) can be provided with a 
copy of these forms upon request. 
 
 
• Veterinarian checks 
Participants must take their dogs to a Veterinarian, as follows:  
• Week 1 (± 14 days) after receiving a dog, at which a dog parasite check will be 
conducted. Veterinary Checklist packet (includes form 23) can be provided at the Home 
Clearing Visit or Week 1 visit. 
• Month 6 (± 28 days) after receiving a dog, at which a dog parasite check will be 
conducted. Veterinary Checklist packet (includes form 23) will be provided at the Month 
03 visit. 

 
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• Month 12 (± 28 days) after receiving a dog, at which an annual comprehensive wellness 
examination will be conducted. This will require assessment of the dog’s weight, major 
body systems and teeth, the dog will be checked for internal and external parasites, the 
dog will have a tooth cleaning and will receive vaccinations for canine communicable 
diseases. Veterinary Checklist packet (includes form 23) will be provided at the Month 
09 visit. 
• Month 17 (± 28 days) after receiving a dog, at which a dog parasite check will be 
conducted. Veterinary Checklist packet (includes form 23) will be provided at the Month 
15 visit and required prior to completion of the Month 18 visit.  
 Completion of this parasite check is a prerequisite for keeping the dog at the end 
of the study.  
 
The participant will be provided with a Veterinary Checklist packet that includes a cover letter, 
contact sheet, the Veterinary Checklist, and a postage paid envelope during the designed visits 
above.  The participant will be instructed to schedule each veterinary check and will be 
responsible for giving the checklist, contact sheet, and postage paid envelope to the selected 
Veterinarian.  Options for returning the Veterinary Checklist include, a) Veterinarian can give 
the completed form to the participant in order for the participant to return it directly to the study 
team; b) Veterinarian can fax the completed form to the study team; and, c) Veterinarian can 
mail the form to the study team using the self addressed stamped envelope.   A VA veterinarian 
will review each Veterinary Checklist and follow up as needed if dog health problems are noted. 
Checklists not returned by the designated due date will require follow up with the participant and 
veterinarian (as needed) to verify that the exam has been completed and retrieve the missing 
checklist. If follow up attempts to retrieve missing forms are unsuccessful site staff will contact 
the CVMO in a timely manner.    
 
 
• Public observation of study dogs 
Public observations will be completed for all paired participants (SD and EMOT) at 2 separate 
times in the study. Sites will use their discretion to conduct the observations either at a required 
visit or by meeting the participant during a scheduled public outing that can be on a different 
date than a required post pairing visit. Public observations will occur at least 6 months apart. 
• Ad Hoc study Visits 
The investigator, local dog trainer, national dog trainer or local study team member may 
schedule an ad hoc visit for any study participant at any time that he/she feels such a visit is 
advisable to evaluate either the participant, dog, or residence.  Any such visits will be 
documented per approved procedures as detailed in the associate study operations manual. 
Examples of reasons for ad hoc visits include supporting the training needs, changes in 
residence, or when a dog, or other pet is introduced into the home that may interfere with the 
study dog bonding relationship with the participant. The Suitability to Have a Dog Checklist, 
Veteran and Service Dog Visit Report, and Dog Related Questions can be administered at the 
discretion of the dog trainer.   

 
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Visit completion schedules: When required, visits can be initiated and completed on different 
dates. If this occurs the completion visit should take place within 2-weeks of the date it was 
initiated and must be completed within the designated early and late date window of time (i.e., + 
14 days). This does not apply to Post Pairing Weeks 1 & 2 visits as these have limited amount of 
time between visits. If holiday schedules or an unusual circumstance such as veteran illness 
prevents the visit within the designated time frame listed above, they should be completed as 
soon as possible. 
 
• Participant Study Completion 
  
• Participants are considered to have completed the study if he or she has successfully 
completed the 18 month visit and all study related activities. 
• SAE monitoring: a final chart review for monitoring SAEs should be completed 
approximately 30 days after the completion of the 18 month visit. If an SAE is identified a 
final SAE form will be submitted to PPCSPCC and CIRB as required. 
• All CRFs should be completed and submitted to PPCSPCC.

 
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XI. 
DOG REMOVALS 
 
• Removal and replacement of the study dog. 
Pairings between Service Dogs/Emotional Support Dogs and study participants may fail because 
a bond is not established between them. Vendors are experts at matching human and animal 
personalities to limit the possibility that this will happen. Based on information from vendors, a 
bonding failure will usually occur within the first two weeks after returning home with a dog. In 
the case of failed bonding, a VA Dog Trainer will intervene and inform a Contracting Officer’s 
Representative (COR), who will inform the vendor. Dogs may also develop disqualifying health 
or behavioral problems at any time after pairing that disrupts the pairing process. In other cases 
the bonding relationship may be interrupted due to short term absences by the participant (i.e., 
hospitalization, transitional housing, etc.) or due to the death of the original study dog in which a 
replacement dog may be sought.  
 
If issues are identified that require the removal of a study dog, site staff will inform their local 
LSI.  The LSI will work with the study Chair, the National Dog Trainer, and other leadership as 
needed to determine whether the dog should be temporarily or permanently removed. If the 
decision to temporarily remove the dog is agreed upon, the research team will assess the 
procedure for determining when and what constitutes resolution of the extenuating circumstances 
and when it would be appropriate to return the dog or offer a replacement dog.  
 
Study leadership will maintain ongoing communication during all temporary removals to 
monitor the situation. Should the circumstances surrounding the temporary removal of the dog 
not get resolved in a reasonable amount of time - as determined by study leadership - the study 
dog may be permanently removed. If the dog is permanently removed with no plan for a 
replacement dog, the participant may be asked to continue in the study to complete follow up 
visits (Intent to Treat).  If the participant does not want to remain in the study they will be 
withdrawn. 
 
Study staff will work with the participant to transport the dog to an approved boarding location 
and, if necessary, ship the dog back to the assigned vendor for boarding and training 
maintenance. During temporary removals, visits will be conducted in the clinic, participants will 
receive $25 per visit, dog measures and veterinarian visits will not be required, ad hoc visits will 
completed as needed by the dog trainer, and the 75$ stipend payment will be prorated.  
 
1. 
Temporary removals resulting in the return of the same study dog 
 
1. The re-introduction of the original study dog will include a number of procedures to support 
the transition of the dog back into the paired relationship. Once the dog is reintroduced, the 
participant will continue on the pre-existing visit and veterinarian exam schedule. If the 
original post pairing monitoring visits (weeks 1 & 2 visits, months 1 & 2 visits) were 
discontinued during the temporary removal they can be reinstated. If needed these visits can 
be reset starting with week 1. If post-pairing monitoring visits overlap existing outcome visits 
(Months 3-18), these visits can be merged based on the guidelines below. Note that one 

 
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exception to this merged schedule is related to the 15 Month visit in which the CAPS should 
be administered in the clinic. 
 
Monitoring Visit  Outcome Visit 
Merged visit type 
Home 
Home 
Home. Payment=$10. 
Home 
Clinic 
Home. Payment=$10. 
Phone 
Home 
Home. Payment=$10. 
Phone 
Clinic 
Clinic. Payment=$25. 
 
The National and Local Dog Trainer will work together to coordinate the transition and set up a 
re-training plan as needed.  The Suitability to Have a Dog Checklist, Veteran and Service Dog 
Visit Report, and Dog Related Questions can be administered at the discretion of the dog trainer 
during the reintroduction period.  
 
2. 
Temporary removals resulting in the pairing of a replacement study dog 
 
If reasonable interventions by VA Dog Trainers in consultation with vendor staff members 
cannot correct the situation, the dog will be returned to the vendor and a replacement may be 
sought. The decision to return a dog to the vendor will be made by the study national dog trainer, 
COR and/or CVMO, in consultation with the study chair, and other study leadership and team 
members. These situations will be dealt with on a case–by-case basis. Data will be collected for 
all replacement dog post pairing visits, but in most cases will not be used for the main analysis 
because data from these participants may skew findings.   
 
Replacement dog procedures include a number of components to help prepare for the new 
pairing and support the participant and dog bonding process. These procedures include: 
 
• The participant will be required to attend another training session at the vendor location (for 
a Service Dog) or schedule another placement session by a VA Dog Trainer (for an 
Emotional Support Dog).  
• Post-pairing Outcome visits (months 3, 6, 9, 12, 15, 18) will continue on the pre-existing visit 
schedule.  This overall study timeline will not reset. 
• The participant will complete a new schedule of post-pairing monitoring visits (weeks 1 & 2, 
months 1 & 2). These visits will overlap, not extend, the overall study timeline.    
• Guidelines for overlapping visits: If post-pairing monitoring visits overlap existing outcome 
visits (Months 3-18), these visits can be merged based on the guidelines below. Note that one 
exception to this merged schedule is related to the 15 Month visit in which the CAPS should 
be administered in the clinic.  
 
Monitoring Visit  Outcome Visit 
Merged visit type 
Home 
Home 
Home. Payment=$10. 
Home 
Clinic 
Home. Payment=$10. 
Phone 
Home 
Home. Payment=$10. 
Phone 
Clinic 
Clinic. Payment=$25. 

 
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• Veterinary Checklist visits will reset starting with week 1. 
• Staff will work with the local dog trainer and National Dog Trainer (as needed) to coordinate 
the pairing or placement process.  For additional information see pairing and placement 
procedures within the Home Clearing Visit section. 
 
• Permanent removal of a study dog (Cessation of Intervention) 
 
In some cases, the study dog will need to be permanently removed from the participant with no 
option of a replacement dog.  Reasons for permanent removal include the inability to resolve the 
issues surrounding a temporary removal in a timely manner, the participant refuses a replacement 
dog, the participant withdraws early from the study due to personal reasons, or the participant is 
terminated  early from the study by research staff due to study related ineligibility.  
 
Participants may be eligible to continue in the study once their study dog has been permanently 
removed. The local LSI and other study leadership, including the study Chair and CMVO, will 
be consulted to determine eligibility for continued follow up. Participants who remain in the 
study will be encouraged to complete all follow-up assessments because follow-up data are 
important to the validity of the study results and for future patient care.   
 
Participants who agree to follow up visits after the permanent removal of their study dog will 
complete all visits in the clinic, receive an incentive payment of $25 for each visit, will not be 
required to complete dog related components (dog surveys, public observations, and veterinary 
exams), and will no longer receive the $75 dog care stipend. If at any time the participant 
requests to be withdrawn from the study or completes the final 18 month visit, the participant 
will be withdrawn from the study.  
 
Participants who agree to follow-up visits in the absence of a study dog and agree to complete 
the Exit Interview should be administered the interview based on the following guidelines: 
  
1. At the permanent dog removal visit (i.e., removal is considered permanent at the time of 
removal), or 
2. By phone within approximately 2 weeks of the permanent dog removal visit or after the decision to 
permanently remove the dog has been made (i.e., temporary removal resulting in a permanent 
removal), or 
3. During the next scheduled study visit following the permanent dog removal visit or after the decision 
to permanently remove the dog has been made (i.e., temporary removal resulting in a permanent 
removal), or 
4. Participants in follow-up without a study dog at the time of this update: by phone at the 
participant’s earliest convenience or during the next scheduled study visit instead of waiting 
until the final study visit. 
 
Participants who refuse follow-up visits or are not otherwise eligible (as determined by 
leadership) will be asked to complete the Exit Interview during the permanent dog removal visit 

 
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or by phone within approximately 2 weeks of the permanent dog removal visit, or after the 
decision to permanently remove the dog has been made. 
 
 
 
  

 
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XII. 
STUDY WITHDRAWAL & TERMINATION 
 
Circumstances surrounding the decision to withdraw a participant can vary from case to case. 
Early withdrawals that result from exclusionary criteria identified during the screening and 
baseline phases tend to be more straightforward and can be processed at the site level. 
Withdrawals that result from early termination of paired participants tend to involve more 
complex and varied circumstances that requires input from multiple members of the leadership 
team. Medical and scientific judgment should be exercised in deciding whether to terminate a 
participant from the study, especially once participants have been paired with a study dog. A 
case-by-case evaluation will be the standard approach to handling decisions to terminate 
participants from the study.  
 
There are a number of reasons that a participant may be terminated/withdrawn from the study. 
These include:  
 
a. Safety concerns: the research team find out it is not safe for the participant to 
remain in the study. For example, the participant’s health worsens. 
b. Missed study appointments: Participants do not keep scheduled study visits. 
c. Lost to follow-up: Participants do not respond to research staff attempts to 
contact them by phone or mail. 
d. Participant’s home is inaccessible to the research team: a participant moves to a 
home that is not accessible to the research team, their existing home becomes 
inaccessible to the research team, or they move out of the study area. 
e. Deployment. 
f. Personal choice: participant decides for any reason that they no longer want to 
take part in the study, or they decide to return your dog or withdraw their study 
consent. 
g. Dog mistreatment: There is evidence that the dog has been physically or 
psychologically abused or mistreated. Signs of mistreatment include evidence that 
the dog:   
• has been hit or kicked (cowering, shaking, head shyness in the presence of the 
participant or a family member) 
• has been tied to an object outside 
• is fearful e.g. the dog stays away from the participant or a family member  
• has lost weight but does not have a medical condition that explains why  
• has skin sores that cannot be explained by a medical condition  
• has gross parasite infection (fleas, ticks) 
• has any other conditions that suggest it has been neglected or abused  
h. Dog health issues/care of dog diminishes: There is evidence that the participant 
cannot adequately care for their dog. 
i. Lack of ongoing treatment: participant stops receiving ongoing mental health 
treatment (i.e., PTSD treatment). 
j. Lack of veterinarian care: participant does not schedule and honor the 
veterinarian visits that are required by the study or they do not take their dog to 
a veterinarian for treatment if it is sick or injured. 

 
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k. Participant death.  
l. Participant no longer meets study criteria (i.e., incarceration, not accepting the 
outcome of the dog randomization, family refuses study dog, substance abuse, 
not able to travel to the vendor (SD group), participant does not follow through 
with study related requirements, etc.). 
m.   
n. Engaging in a relationship with vendor: participant donates to, works for, or 
volunteers with a vendor providing dogs while they are still in the study. 
o. No secondary dog caregiver during intermittent absences: participant does not 
have someone who is able to care for their dog during short term absences.  
p. Dual enrollment in an unapproved study.  
q. Obtains outside training for their study dog: While in the study, participant-
initiated training of study dogs by outside sources is prohibited.  All training 
needs will be met by the designated vendor and VA dog trainers (local or 
national). 
r. Not reporting aggressive behaviors or displays of aggression by the dog. 
 
 
1. 
Pre-pairing Terminations 
If study team members have concerns about a participant’s eligibility prior to pairing, they 
should consult with the LSI. If the LSI has questions about the participant’s status they can 
consult with the study Chair to help make a determination. Additional leadership will be 
consulted by the LSI and Chair as needed.  
 
2. 
Post-Pairing Terminations  
The study team will consult with the LSI to review the circumstances surrounding potential early 
termination  of paired participants.  If the LSI agrees that the participant should be terminated 
early they will consult with the Chair to review the case and if applicable develop a summary 
report to share with the CVMO and coordinating center. There may be cases that require 
additional guidance from the Executive Committee and/or the Human Rights Committee. Final 
approval for early termination  will be made by study leadership, including the study Chair .   
 
Participants that are paired with a study dog and withdrawn early from the study will be required 
to return their dog to the VA.  
 
3. 
Lost to follow-up:  
Participants who do not respond to weekly phone calls over a 4 week period will be mailed a pre-
withdrawal letter to their last know address.  If within 2 to 3 weeks of mailing the letter the 
participant does not respond they will be considered lost to follow-up.  Important factors related 
to this decision and the decision to terminate the participant includes (i) whether or not the 
participant has been paired with a study dog, (ii) mental, physical and emotional health of the 
participant, and (iii) prior study-related issues.  
 

 
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The decision to terminate participants considered lost to follow-up who have not been paired will 
be based on consultation between the LSI and study Chair. Lost to follow-up participants who 
have been paired with a study dog but have had their dogs temporarily removed will require 
consultation between the LSI, Chair, and other leadership as outlined in the Post-Pairing 
Terminations section.  Paired participants lost to follow-up who are in possession of their study 
dog should not be terminated  from the study until the study dog has been returned to the VA and 
approval has been obtained.. If the study ends prior to the resolution of these cases, study 
leadership, including the Chair and CVMO, will work together to develop a plan of action for 
retrieving the study dog and terminating  the participant.  If alerts in CPRS or other VA systems 
are available these will be implemented to assist with contacting the participant and retrieving 
the study dog. 
 
 
4. 
Study Withdrawal/Termination Procedures. 
 
• Paired participants who have been terminated early from the study should be provided 
with a withdrawal letter at the participant’s last visit. If the participant refuses the letter or 
staff is not able to provide the participant with the letter at the time of the final visit these 
reasons should be documented and the letter filed in the participant study record. 
• If applicable, the Exit Interview should be administered to the participant prior to 
officially withdrawing the participant early from the study. Participants will receive $10 
for their voluntary completion of this interview. 
• A final chart review for monitoring of SAEs should be completed approximately 30 days 
after the decision to withdraw/terminate the participant from the study has been made. If 
an SAE is identified the final SAE form will be submitted to PPCSPCC and CIRB as 
required. 
• CPRS record must be updated. 
• If a HIPAA revocation form is signed, a copy should be submitted to CSP and the 
original filed locally with the consent, an addendum note in CPRS regarding the 
revocation process should be submitted, and the study termination form (form 24) 
updated to reflect this process. 
• All CRFs must be completed and submitted to PPCSPCC.

 
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XIII. MONITORING AND REPORTING ADVERSE EVENTS 
 
• Importance of Adverse Event Reporting 
Timely and complete reporting of safety information assists study management in identifying 
any untoward medical occurrence, thereby allowing:  a) protection of safety of study 
participants, b) a greater understanding of the overall safety profile of the study treatments and 
therapeutic modalities, c) improvements in study design or procedures, and d) compliance with 
regulatory requirements. 
• Role of the Site Investigator in Adverse Event Monitoring 
The site investigator will be responsible for the adverse event reporting requirements as outlined 
below: 
• Reviewing the accuracy and completeness of all adverse events (AE) reported. 
• Compliance with VA CIRB policies for reporting AEs and/or serious adverse events 
(SAEs) (see VHA Handbook 1058.01 and CIRB website for details) 
• Closely monitoring research participants at each study visit for any new SAEs. 
 
• Collection of Safety Information 
1. 
Adverse Events 
 
The International Conference on Harmonization (ICH) defines adverse events (AEs) for Clinical 
Safety Data Management (ICH-E2A) as “any untoward medical occurrence in a clinical 
investigation subject that is subjected to one of the study treatments that do not necessarily have 
to have a causal relationship with the treatments.  An AE, therefore, can be any unfavorable or 
unintended sign (including an abnormal laboratory finding), symptom, or disease temporally 
associated with the study interventions.” 
 
For the purposes of this study, the study interventions are: a) being paired with a Service Dog 
and b) being paired with an Emotional Support Dog.  
In this study, information on AEs related to or possibly related to study intervention for the 
participant, participant family members, or the study dog, and on all serious adverse events 
(SAEs) will be collected and recorded. See the section below on “Relatedness”.  A separate 
section below describes the collection of safety information for SAEs. 
The reporting period for AEs begins when the participant signs the informed consent form and 
continues until 30 days after: the participant’s completion, early termination of study 
participation, or the end of the study (whichever comes earlier).  Each related/possibly related 
AE will be reported to the Sponsor, the VA Cooperative Studies Program, including any increase 
in frequency or severity of a condition that was present prior to the start of the study.  During the 
study, adverse events can be spontaneously reported or elicited during open-ended questioning, 
examination, or evaluation of the participant at study visits.   

 
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Related or possibly related adverse events not meeting the criteria for an SAE (see below) must 
be recorded on the Adverse Event Form.  (Those that meet SAE criteria are documented on the 
SAE Form.)  One form should be completed for each AE reported.  Adverse events should be 
reported in sequential order as they occur and submitted with the other case report forms for the 
participant’s visit.   
Relatedness involves an assessment of the degree of causality (attributability) between the study 
intervention and the event.  The assessment provided by the site investigator is part of the 
information used by the sponsor to determine if the adverse event presents a participant safety 
concern.  Pursuant to CSP Global SOP 3.6, an AE is deemed to be associated with the use of a 
study intervention if “[t]here is a reasonable possibility that the experience may have been 
caused by the intervention or by participation in the trial.” Thus, all adverse events with a 
reasonable causal relationship to the study intervention should be considered “related”.  A 
definite relationship does not need to be established.  The following levels of relatedness will be 
used in this trial: 
• Not attributed to a study intervention (study dog) 
• Possibly attributed to a study intervention (study dog) 
• Attributed to a study intervention (study dog) 
Only possibly related or related events must be reported on a study form. 
2. 
Adverse Event Definitions for Animals   
 
The USDA Animal Welfare Act Regulations (AWAR) and Public Health Service Policy on the 
Care and Use of Animals in Research (“PHS Policy”) govern animal research involving dogs.  
All VA-funded animal research must also comply with the rules and policies utilized by the 
accrediting body for animal research, which is the Association for Assessment and Accreditation 
of Laboratory Animal Care (AAALAC).   VA policy incorporating these federal and accrediting 
standards is found in ORD Handbook 1200.07, Use of Animals in Research (11/23/2011), and 
ORO Handbook 1058.01, Research Compliance Reporting Requirements (11/15/2011; primarily 
paragraph 8). 
 
Cumulative reporting requirements for IACUCs are found in VHA Handbook 1200.07, item 8.i, 
which lists the following categories of reportable deficiencies applicable to this study. These 
include (a) serious or continuing non-compliance with PHS Policy (including any serious 
deviation or continuing non-compliance with the provisions of the Guide, as required by the PHS 
Policy) or USDA AWAR, and (b) suspensions of protocols previously approved or suspensions 
of procedures or studies never given approval.  
As federal regulations and VA policy apply to this study, each site IACUC will be required to 
monitor the dogs enrolled at that site. Site IACUC’s will ensure that (a) the dogs are used 
according to the protocol approved by the IACUC, (b) that the dogs receive appropriate 
veterinary care as needed, (c) not more than the approved number of dogs are used, and (d) that 
the dogs do not pose a health (e.g., zoonotic parasites) or safety (e.g., biting) risk to people or 

 
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other animals that are around them.  If the IACUC finds that any of these expectations have not 
been met, then they must investigate the matter, determine if corrective actions are needed, 
report the non-compliance if the matter qualifies, and monitor the corrective actions to make sure 
the issue is resolved and that proper measures are in place to prevent recurrence of the problem. 
The term “adverse event” is not defined for animal research issues, but the following shall be 
considered an AE for the purposes of this study, and deemed reportable: 
1. 
Bites of any level according to the Dunbar dog bite scale 
(http://www.apdt.com/veterinary/assets/pdf/Ian Dunbar Dog Bite Scale.pdf).  The 
scale ranges from obnoxious or aggressive behavior but no skin contact by the 
dog’s teeth (Level 1) to slight bleeding caused by a tooth laceration without a 
puncture (Level 2) to increasingly deep tooth punctures of the skin (Levels 3 and 4 ) 
to multiple Level 3 or 4 bites (Level 5) to death (Level 6).  
2. 
Any herding or similar aggressive behavior toward children.  In experience, such 
dominance behavior is a precursor to biting incidents. 
3. 
Diagnosis of any zoonotic parasitic or other disease in the participant, participant’s 
family, or in people with regular contact with the dog.  This would include 
intestinal parasites such as hookworms, roundworms, and giardia, as well as 
bacterial diseases such as salmonellosis or leptospirosis.  It would also include 
fungal infection of the skin such as ringworm.             
4. 
Unprovoked aggression against other dogs or cats.   
5. 
Aggression of any kind toward people who are exposed to the dog under any 
environment.  This does not imply that there are no circumstances in which 
aggression might be acceptable (e.g., physical attack by a person or dog on a 
participant or another person would be warranted), but the matter should be 
reported and investigated.  
6. 
Any indication that a dog is being mistreated in the home environment by any 
member of the household. 
7. 
Repeated refusal by the participant to go to routine veterinary visits, or decisions 
not to seek veterinary treatment for dog injuries or significant illnesses. 
8. 
Diagnosis of chronic illness, hip or elbow dysplasia, or a genetic condition 
refractory to treatment that will likely reduce the working life of a Service Dog or 
the ability of an Emotional Support Dog to be a potentially positive factor on the 
participant.   
 
• Adverse Event Follow-Up 
For each reported AE, site investigators follow up with participants until the event resolves and 
ensure that appropriate care is provided, but there is no case report form to fill for AE follow-up.  

 
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Adverse events must be reported as Serious Adverse Events (SAE) if they meet the SAE 
reporting requirements described below.   
• Serious Adverse Events 
1. 
Definition of Serious Adverse Event (SAE) 
 
Serious adverse events are defined by the ICH for Clinical Safety Data Management and CSP 
Global SOP 3.6.2, as any untoward medical occurrence that: 
• Results in death,  
• Is life threatening, 
• Requires inpatient hospitalization or prolongation of existing hospitalization, 
• Results in persistent or significant disability or incapacity, 
• Is a congenital anomaly/birth defect, or 
• Any other condition that, based upon medical judgment, may jeopardize the subject and 
require medical, surgical, behavioral, social or other intervention to prevent such an 
outcome. 
Any adverse event that meets the definition of “Serious” will be reported on an SAE Form.  All 
SAEs will be classified as either “related,” "possibly related," or “not related” to study 
intervention.  A definite causal relationship does not need to be established. 
2. 
Serious Adverse Event Monitoring 
 
Participants will be monitored for SAEs at each study visit and during any contact with the 
participant.  Each serious adverse event is reported on an SAE Form.  Active monitoring for 
SAEs begins at the time the Informed Consent Form is signed and continues until the earlier of 
the 30 days after the participant’s completion, early termination of study participation, or the end 
of the study.  The final SAE monitoring review can be completed by a chart review. The date 
study participation ends is entered on the Study Completion/Termination Form.  Safety data from 
the pre-randomization and post-pairing periods will be analyzed separately.  
3. 
Expedited Reporting of Serious Adverse Events 
 
All SAEs require prompt reporting to the CSP Coordinating Center and CSP Clinical Research 
Pharmacy Coordinating Center (CSPCRPCC) within 72 hours of the site investigator becoming 
aware of the event. The Adverse Event (AE) Specialist at the CSPCRPCC is responsible for 
evaluating all SAEs for participant safety concerns and regulatory reporting.  The AE Specialist 
will consult with the Chairman’s office during the review process, as necessary.   

 
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* Because of the high profile of this study, certain SAEs must be reported to the sponsor within 
12 hours of the site investigator being made aware of the event.  These events include any dog 
deaths, dog bites, or participant deaths.   
CSPCPRCC maintains a database of serious events for evaluation, by using the Medical 
Dictionary for Regulatory Activities (MedDRA) for coding and trending.  Periodic summaries 
will be provided to the Data Monitoring Committee, the Study Chairman’s office and Executive 
Committee (as necessary).  Events that are determined to be serious, unexpected, and related to 
the study treatments will be reported to the site investigators, Chair’s office, and to the VA 
Cooperative Studies Program Central Office. CIRB policy will likely mirror these reporting 
requirements so it is important to review and understand these requirements as well.  The CIRB 
website provides a number of resources related to current CIRB policy and SOPs.      
SAE Forms will be sent to the Perry Point CSPCC as directed.  The CSPCRPCC will also have 
access to the information on the SAE Forms.  
4. 
SAE Follow-up Reporting 
 
If additional information is require the CSPCC or CSPCRPCC will fax or email a request to the 
site personnel reporting the SAE. The site should handle requests for SAE follow-up information 
in the same prompt manner that original SAE reports are handled. Serious adverse events should 
be followed to resolution, stabilization, or the end of the study, whichever occurs first.  If an 
SAE is still ongoing by the time the SAE Form is submitted to the Perry Point CSPCC, complete 
an SAE Follow-up Form every 30 days until the SAE is resolved or stabilized.  SAE Follow-up 
Forms will be sent to the Perry Point CSPCC.  
• Reporting Adverse Events and Serious Adverse Events to the VA Central IRB 
It is the responsibility of the site investigator / coordinator at each participating site to know and 
comply with the AE and SAE reporting requirements of the VA CIRB.   
• Reporting Adverse Events and Serious Adverse Events to the Study DMC and other 
Oversight Bodies 
The CSPCRPCC is responsible, in conjunction with the CSPCC, for coding study safety data 
into the MedDRA (Medical Dictionary for Regulatory Affairs) Dictionary and creating event 
tabulations.  The study biostatistician will present a summary of those events to the data 
monitoring committee (DMC) on a schedule set by the DMC. The DMC will recommend to the 
CSRD Director whether the study should continue or be stopped for safety reasons. Summary 
reports from the DMC will be provided to each site for their records.  
 
Unexpected AEs and SAEs will be reported to the Study Chairs’ Office.  The Study Chairs and 
the CSPCC Directors will report SAEs that are determined to be both related to the investigative 
treatment and unexpected to the CSRD Director and site investigators after review. 
 

 
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• Reporting Adverse Events and Serious Adverse Events to the IACUC 
The site investigators will report all SAEs and Unanticipated Problems involving risks to animals 
to their individual site IACUC committee and to the Chief Veterinarian Medical Officer. 
 
The AE Specialist at the CSPCRPCC will address questions about managing or reporting of 
adverse events or serious adverse events. 
• Additional Safety Concerns 
1. 
Unmasking the study treatment 
The study treatment is not blinded, thus unmasking is not applicable in this protocol. 
 
2. 
Discontinuation of treatment (removal of dog) 
A participant may be terminated from the study. If so, the dog will be removed. Medical and 
scientific judgment should be exercised in deciding whether to terminate a participant from the 
study.  Before any paired participant is terminated, the site investigator must contact the study 
chair for instructions and approval.  A participant may be terminated and the dog removed from 
a participant if: 
 
a. 
Participant does not keep scheduled study visits and does not respond to phone 
calls or attempt to reschedule appointments. See Lost to Follow-Up section for 
additional details.  
b. 
Participant moves so far away that the study team cannot practically continue to 
make home visits  
c. 
Participant is deployed 
d. 
Participant withdraws from study and chooses to return dog  
e. 
There is evidence that the dog has been physically or psychologically abused or 
mistreated  
f. 
There is evidence that the participant is failing to keep the dog healthy  
g. 
Participant has not maintained mental health treatment 
h. 
Participant is no longer able or willing to provide adequate care for dog 
i. 
Participant fails to schedule and honor required initial, 6-month and 17-month 
parasite checks, or 12-month wellness check, or fails to take a sick dog to a 
veterinarian for treatment of a serious illness or injury.  
 
For a comprehensive list of reasons that may lead to withdrawal and/or dog removal see the 
STUDY WITHDRAWAL & TERMINATION section. 
 
• Risks to subject  
Various risks have been identified in the Informed Consent document regarding risks to 
subjects.The following lists the procedures which should be followed if any incident occurs. 
   
a. Dog bites: The study team is obtaining dogs from vendors known to provide 
quality dogs, is providing training on preventing dog bites as a prerequisite for 

 
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receiving a dog, and is monitoring participants and dogs with VA Dog Trainers to 
identify behaviors or situations that can be modified to reduce the chance of bites. 
For these reasons, the study team feels that the risk of bites is less than what is 
seen in the general public.  
a. In the event of a dog bite, the following individuals should be immediately 
informed:  
Mark.mccranie@va.gov  
Michael.fallon@va.gov 
Derrick.tillman@va.gov     
Eileen.Stock@va.gov 
Leslie.Norman@va.gov 
Joan.Richerson@va.gov 
Amanda.Snodgrass@va.gov 
 
1. Dog death: A dog may die while in the study, but it is expected to be a rare 
occurrence.  
a. The study team is obtaining dogs from vendors, which have bred their dogs to 
reduce common diseases and problems.  
 In the event of a dog death, the participant will be contacted by the study 
team’s mental health professional and his/her own mental health provider will 
be called.  Grief counseling for the participant will be provided as needed. 
 The dog will be replaced if the participant so chooses. The participant will 
receive the same dog type as they previously had. Data collection will 
continue on the same timeline as prior to the dog’s death.  
 If the Veteran does not want another dog, then the participant should be 
terminated from the study. If the participant is willing data collection should 
continue on the same timeline as prior to the dog’s death. .  
 In the event of a dog death, the following individuals should be immediately 
informed:  
Mark.mccranie@va.gov  
Michael.fallon@va.gov 
Derrick.tillman@va.gov    
Eileen.Stock@va.gov 
Leslie.Norman@va.gov 
Joan.Richerson@va.gov 
Amanda.Snodgrass@va.gov 
 
 
2. Distress from interviews or questionnaires: Information collected on the 
questionnaires and interviews may upset the participant. To mitigate this risk, 
interviewers will allow plenty of time for the participant to answer questions and will 
offer breaks as necessary. The data collector may recommend that the participant 
contact his/her mental health provider to help with feelings. 
 In the event that a participant is distressed during questionnaire/interview 
completion he/she should be given the option to terminate the visit 

 
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immediately. If the participant is open to it, the visit may be continued on 
another occasion. The occurrence of this will be  documented through the 
differing dates on CRFs received by PPCSPCC. The data collector may 
recommend that the participant contact his/her mental health provider to help 
with feelings. 
 If the LSI and members of the local study team consider continued study 
participation to be too distressing for a participant they may choose to 
terminate the participant from the study. Decisions regarding termination from 
the study will be made by the LSI, and members of the local study team on a 
case-by-case basis.  
 
3. Financial Risk. Because the well-being and medical/surgical insurance taken out on 
each dog by VA pays 100 percent of eligible veterinary costs with no co-pay or out-
of-pocket expenses to the participants, and because all participants will receive $75 
per month for incidental expenses plus a coupon for dog food that should cover food 
costs, financial risk is considered to be low for participants while in the study. 
However, once participants complete the study, they will be responsible for all dog 
care and veterinary costs, which has been disclosed in the ICF. 
 
4. Additional risks include the loss of sensitive information. The study team will do 
everything possible to prevent this from occurring.  
 
5. Participants will be informed as soon as possible if additional risks are identified as a 
result of participating in this study. 
 
 
• Benefits for study 
Participants will be notified that the study team cannot promise that he/she will receive any 
benefits from taking part in this research study.  The participant will also be told that he/she may 
gain benefits by interacting with the dog received. 

 
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XIV. HEALTHCARE UTILIZATION & EMPLOYMENT/PRODUCTIVITY 
ANALYSIS  
 
VA administrative data sets will be the source of health care utilization. The hospital discharge 
data and the outpatient encounters datasets available from the VA Corporate Data Warehouse 
will be used to characterize health services used by participants.  National data extracts of the 
Decision Support System (DSS) will be used to characterize the cost of care.  VA to determine 
the cost of every hospital stay, patient care encounter, uses this cost system and other service 
dispensed to patients.  Data will come from the DSS discharge, outpatient visit, and outpatient 
prescription extracts.   The DSS data system has been in use at all VA sites for more than 10 
years, and the vast majority of encounters are assigned cost estimates that are consistent with 
private sector costs for similar services (Barnett & Rodgers, 1999).   A very small number of 
DSS cost estimates (much less than 1%) are inconsistent with the expected cost given the 
characteristics of care.  Inconsistent cost estimates will be identified by comparing the DSS data 
to the encounter level cost estimates in the average cost database created by the Health 
Economics Resource Center (Barnett, 2003; Phibbs et al, 2003; Wagner et al, 2003). HERC 
estimates the cost of VA health care counters based on the average cost of similar encounters in 
the non-VA sector.  HERC cost estimates will be substituted for the 1% extremes of DSS data 
that are inconsistent with expected costs.  
 
Inpatient care will be considered related to mental health if the stay was in a specialized mental 
health bed section, or if the primary discharge diagnosis was a mental health disorder (an ICD-9 
code in the range between 290 and 390).  Outpatient care will be considered related to mental 
health if the visit was to psychiatric clinic stop code or was characterized by any mental health 
diagnosis code.  
 
Mental health medications will be identified using the VA medication class variable which is 
used to characterize medications in the DSS pharmacy data.  We will classify as mental health 
medications: anti-depressants (CNS600-CN699), anti-psychotics (CN700-CN799), and other 
classes of medications used in treatment of PTSD.  We will work with site investigators to 
develop a list of medications being prescribed for sleep disorders at study sites, include off-label 
use of low-dose anti-depressants.   
  
Participants will be queried regarding their non-VA utilization using the HERC-developed 
standard questions regarding outpatient and inpatient utilization (including Emergency 
Department visits).  The mean VA DSS unit cost will be used for the same type of utilization for 
the cohort of PTSD patients as estimates of the cost of these non-VA services. 
 
Participants will be asked for an authorization under HIPAA for use of VA data on the quantity 
and cost of health services they use during the trial.  Participants will be queried regarding their 
employment and work productivity at baseline and during each follow-up visit, using the Work 
Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (Reilly et al, 
1993).    The questions in this survey will be rephrased to ask about the effect of PTSD on 
employment and productivity.  The WPAI V2.0 queries respondents about their productivity at 
Work by asking, “During the past seven days, how much did your health problems affect your 

 
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productivity while you were working?” Respondents answer the question by choosing an integer 
ranging from 0 to 10.  The WPAI V2.0 also queries respondents about ability to engage in 
regular daily activities.  Respondents are asked, “During the past seven days, how much did your 
health problems affect your ability to do your regular daily activities, other than work at a job?” 
 
• Activities of Economic Team 
The economic team will be responsible for data evaluation and analysis in different phases of the 
study, as described below. 
 
1. 
Activities prior to start-up 
 
The economic team will create study forms pertaining to economic data.  The team will review 
the HIPAA waiver and research consent forms to be sure that they include economic data and 
describe the participation of the economic team.  An application to use cost and utilization data, 
and to work with the social security numbers of study participants, will be submitted to National 
Data Systems.   A “study binder” will be created with regulatory documents, protocol, and other 
documents. 
 
2. 
Activities after study enrollment begins 
 
Under the direction of the study economist, the economic statistical analyst will conduct the 
following activities:  The analyst will evaluate economic data submitted on case report forms.  
Data from initial patients will be evaluated for consistency and interpretability, and feedback 
provided to study staff via the coordinating center.  Periodic reviews of case report forms will 
continue throughout the study.  The research associate will submit continuing review for IRB. 
 
A cohort file, including enrollee social security numbers (SSN’s) from coordinating center, will 
be obtained.  This file will be transmitted securely to the VA Corporate Data Warehouse (CDW).  
The SSNs of study participants will be used to identify patients in the patient file in CDW, and 
the associated CDW identifiers for that patient.  SSN’s that cannot be found will be flagged for 
follow-up.  Previous trials have demonstrated that transcription errors will be made in about 2-
5% of the SSN’s of study enrollees.  The economic team will confirm there was VA utilization 
around time of enrollment. The true social security number will be excluded from subsequent 
analytical steps.  Data on health care cost and utilization of study subjects is extracted from VA 
administrative files based on the encrypted social security number.  The resulting dataset 
contains the actual date each service was provided.   
 
The analyst will develop and update programs to determine baseline demographics, utilization, 
and cost, and to determine utilization and cost during trial follow-up period.  Cost and utilization 
data gathered for the economic study can only be accessed by members of the HERC economic 
study team. Access is restricted to the individuals working on the study: the economist, 
programmer, and research assistant 
 

 
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3. 
Activities after study follow-up is complete  
 
The analyst and economist will create a data set of trial participant from case report forms, and 
VA cost and utilization data.  These data will have quarterly observations of health care 
utilization and cost from study enrollment until the end of follow-up.    A repeated measures 
dataset of employment data will also be created.  The economic team will prepare analytic tables 
and a one or more papers with the economic findings of the trial.

 
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XV. 
QUALITY CONTROL PROCEDURES 
 
• Standardization/Validation of Measurements 
Prior to the start of the study, each site investigator and local study coordinator will attend a 
training meeting to ensure that they understand the technical aspects of the protocol. This will 
ensure uniformity in the completion of data forms and in the conduct of study procedures.   
 
Specific training to be provided: 
• Informed consent and study procedures training  
• Study specific informed consent procedures and Service Dog issues.   
• Randomization and assessment schedules.   
• General processes for completion of all forms for data collection 
• Recruitment and screening procedures 
• Training on use and administration of all study measures (WHO-DAS 2.0, CAPS,  PCL-
5, PHQ-9, VR-12, WPAI, GPH V2.0, HERC- survey of non-VA health care utilization, 
Suitability to Have  a Dog Checklist, Dog Related Questions for Service Dogs and 
Emotional Support Dogs, Service Dog/Emotional Support Dog Post Evaluation 
questions). 
 
Perry Point Coordinating Center Staff will work with any individual unable to attend the training 
meeting to ensure that they receive the training above.  
 
All study chairs, site personnel and primary CSP study team members will be required to 
complete the following training courses.  
1. CITI  
a. Good Clinical Practices  
b. Working with the IACUC 
c. Working with Dogs 
2. Mandatory VA research classes per local site 
3. C-SSRS training  
 
 
• Protocol Violations 
Any protocol violation will be reported immediately to the Chairman’s office and the Perry Point 
CSPCC.  Each of these groups then reserves the right to forward notification, as required by local 
policy and regulation.  Protocol violations will be forwarded to the VA cIRB based upon 
guidelines provided.  There are no approved protocol deviations.  Any deviation from the 
protocol will be considered a protocol violation. 
 
• Probation/Termination of Participating Centers 
Each participating site is expected to consent approximately 100 participants during the 18-
month recruitment period in order to reach approximately 74 pairings per site. This is 
approximately five participants per month. Sites are permitted to recruit more participants per 

 
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month if it is feasible. If by month three a site has enrolled no participants, that site can be placed 
on immediate probation. This decision will be made by study leadership. 
 
If a site is placed on probation, it will have six months to have probation removed before being  
terminated as a CSP site. At the start of the Probation Period, a conference call will be held to 
determine the reasons for failure to recruit. If the failure to recruit is a function of specific 
eligibility criteria, e.g. no participants willing to travel for the study, the Chairs will address it 
with the Executive Committee and potentially other sites. If the failure to recruit is a function of 
study personnel, help will be provided to correct the situation. The site will be expected to over 
recruit in the following months to enable sufficient subjects recruited during the enrollment 
phase. During the probation period, weekly calls will occur between the site investigator and the 
national study coordinator to determine whether there are improvements in recruitment efforts.  
 
• Plan to be implemented if enrollment goals are not met 
If enrollment falls short of anticipated goals, the following will be considered to improve 
participant recruitment: 
• Eligibility criteria will be reassessed to determine if there are any alterations in 
inclusion/exclusion criteria that could be made to increase recruitment. A conference 
call/meeting of the Executive Committee with site PIs will occur to discuss any 
change in eligibility criteria. 
• Additional sites will be considered, if needed.

 
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XVI. DATA MANAGEMENT 
 
• Data Security at the VA 
CSP has a commitment to maintain data security and participant privacy.  Standard CSP 
practices and policies for the conduct of clinical research studies have been implemented and 
reviewed periodically.  CSP Center Directors are responsible for ensuring that all CSP Data 
Security Policies are enforced within their Centers.  CSP employees are responsible for 
following all CSP Data Security Policies when conducting study work.  All study data collected 
will be handled, maintained and stored at CSPCC and participating sites according to the CSP 
standard practices and policies. These include: 
• Protected Health Information (PHI) as defined by the HIPAA will not be used for any 
purpose that is not related to the activities of this study. 
• CSP study data are maintained in secure files and records are identified only by a 
participant identification number. 
o Participant identification numbers are not derived from or related to information 
about an individual. 
o All electronic PHI are stored on secure servers and may not be moved to a PC or 
other external device. 
o Paper CRFs are stored in locked file cabinets and rooms. 
• Highly confidential protected health information (HCPHI: names, SSN, physical and 
electronic addresses and phone numbers) collected by the study are defined in the 
informed consent or privacy authorization document, and are stored separately from 
other study data. 
o Electronic HCPHI is encrypted and password protected and paper CRFs 
containing HCPHI are stored in locked filing cabinets and rooms. 
• When necessary, PHI (exclusive of HCPHI) may be transported between secure 
servers. PHI must be encrypted and password protected while being transferred using 
a FIPS 140-2 certified program.  Any removable storage device used to transfer PHI 
(e.g., hard-copy printouts, data tapes, CD’s, USB drivers, etc.) should either be 
destroyed after transfer is complete or given to the Data Security Administrator to be 
stored in a secure, fireproof safe.  A trackable mail system must be used for the 
physical data transfers. 
• No PHI may be sent via MS Outlook or Exchange unless the message is secured 
utilizing encryption and VA authorized security protocol. 
• Documents sent for medical evaluation purposes (e.g., endpoint adjudication) are sent 
via trackable express mail.  Personal information is redacted by the VAMC or 
CSPCC if not determined to be necessary for completing the evaluation. 
• Only VA-owned equipment or equipment configured to VA security standards is 
permitted to connect to the CSP networks in accordance with VA Directive 6504. 
• Training, reminders, and signed data security statements are used to ensure CSP and 
participating site personnel understand VA policies. 
 

 
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Sharing of CSP study data outside of CSP requires the approval of the Director, CSRD and data 
use agreements. In addition, sharing of data outside of VA requires local ISO, PO and ACOS-R 
approvals. 
 
CSP and local study personnel who are no longer part of the research team will not have access 
to any research study data. 
 
• Data Security for Vendors:  
Information will be shared to the vendor in order to allow for pairing. In order to allow for data 
sharing, all contractors will have to follow VHA requirements for data security: 
• complete the data security training (on Talent Management System (TMS))  
• complete background checks 
• a data use agreement may be needed  
• CSP Coordinating Center will help with the vendors receiving training and obtaining 
background checks. 
 
Appendix A of the contract to the vendors will be reviewed by the VA Central Office ISO as 
well as by the Perry Point ISO to allow for appropriate approvals.  Vendors will receive the 
participant information from CSP Coordinating Center by a secure fax or telephone.  
a. Information will be stored in locked file cabinets, in a locked room in which only 
those employees of the vendor that have undergone training and background check 
will have access.  
Vendors who choose to have computer systems that meet the compliance level of the VA will be 
able to store information electronically.   
 
• Data from pilot study on Service Dogs 
Data currently exists from the ongoing pilot study on Service Dogs for Veterans with PTSD.  A 
data use agreement will be developed between James A Haley Veterans Hospital and Perry Point 
CSP Coordinating Center to allow data from preliminary study to be shared and used in future 
analysis.  
 
• Data Collection and Data Entry 
 
Data management will be performed by the VA CSPCC Perry Point, MD using DataFax, a type 
of data management software.  The CSPCC will have overall responsibility for the data at the 
end of the study. 
 
Data will be collected at the study sites on source documents, which will be entered at the site 
into paper CRFs (unless the CRF is the source document).  The blank CRFs will be supplied by 
the VA CSPCC Perry Point, MD.  CRFs are to be completed on an ongoing basis during the 
study.  The medical chart and the source documents are the source of verification of data.  CRFs 
should be completed according to the instructions in the study operations manual.  The site 
investigator is responsible for maintaining accurate, complete and up-to-date records for each 

 
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subject.  The site investigator is also responsible for maintaining any source documentation 
related to the study. 
   
Completed CRFs will be sent by center personnel on a regular basis to the DataFax system at the 
VA CSPCC Perry Point, MD.  DataFax allows the clinical centers to retain the original CRF and 
source documents while providing an image to the VA CSPCC.  Data within the image are then 
checked for accuracy/completeness and entered into the study’s database using DataFax 
software.  Data received at the VA Perry Point CSPCC will be reviewed, verified and edited 
before being entered into the main study database.  If incomplete or inaccurate data are found, a 
data clarification request will be forwarded to the clinical site for a response.  Sites will resolve 
data inconsistencies and errors before resending the corrected CRFs to the VA CSPCC.  All 
corrections and changes to the data will be reviewed before being entered into the main study 
database.  The participating sites will receive reports at least monthly regarding the quality and 
quantity of data submitted to the VA Perry Point CSPCC. 
 
Site investigators agree to routine data audits by the staff of the VA CSP monitoring unit, as well 
as by the CSPCC staff.  The VA CSP monitors will routinely visit each site to assure that data 
submitted on the appropriate forms are in agreement with source documents at the sites.  They 
will also verify that subject informed consent for study participation has been obtained and 
documented in the subject’s progress notes, all essential documents required by GCP regulations 
are on file, and sites are conducting the study according to the research protocol.  Any 
inconsistencies will be resolved, and any changes to the data forms will be made using 
established VA CSPCC Perry Point procedures. 
 
When the study is completed and all data have been entered into the database and the database 
has been checked for quality and is locked, the CSPCC statisticians will perform statistical 
analyses of the data in accordance with the Statistical Analysis Plan (SAP).  Periodically, during 
the study, CSPCC will prepare various summary reports of the data so that progress of the study 
can be monitored.  These reports will be prepared for the Data Monitoring Committee (DMC) 
and other committees, as appropriate. 
 
• Study Documentation and Records Retention 
Study documentation includes all paper CRFs, data clarification forms, source documents, 
monitoring logs and appointment schedules, investigator correspondence and regulatory 
documents (e.g., signed protocol and amendments, IRB correspondence and approved consent 
form and signed informed consent forms, Statement of Investigator form, etc.).  
 
Source documents include all recordings of observations or notations of clinical activities and all 
reports and records necessary for the evaluation and reconstruction of the study.  Thus, source 
documents include, but are not limited to clinical reports, participant completed assessments, 
progress notes, hospital charts or pharmacy records and any other reports or records of any 
procedure performed in accordance with the protocol. 
 

 
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Whenever possible, the original recording of an observation should be retained as the source 
document; however, a photocopy is acceptable provided that it is a clear, legible, and exact 
duplication of the original document. 
 
Research records for all study participants are to be maintained by the site investigator in 
accordance with the VA record control schedule until notified by CSPCC.  These records are to 
be maintained in compliance with IRB, State and Federal requirements, whichever is longest. It 
is the site investigator’s responsibility to retain copies of the completed CRFs until notified in 
writing by CSPCC that they can be destroyed.  In all instances, the site must get permission from 
CSPCC prior to disposition of any study documentation and materials.

 
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XVII.  GOOD CLINICAL PRACTICES 
 
• Good Clinical Practices (GCP) 
This trial will be conducted in compliance with Good Clinical Practices (GCP) regulations.  The 
intent of these regulations is to safeguard participants’ welfare and assure the validity of data 
resulting from the clinical research.  The VA Cooperative Studies Program will assist site 
investigators  in complying with GCP requirements through its Site Monitoring, Auditing and 
Resource Team (SMART) based in Albuquerque, NM.  SMART serves as the Quality Assurance 
arm of CSP for GCP compliance.  SMART will provide training, manuals and materials to assist 
study personnel in organizing study files and will be available throughout the trial to advise and 
assist LSIs regarding GCP issues.   
 
Monitoring of sites participating in the trial will be executed according to Cooperative Studies 
Program (CSP) guidelines.  SMART will conduct initiation visits at each site soon after study 
start-up. Additional monitoring visits may be conducted as deemed necessary by study 
leadership or SMART.  For-cause audits will be conducted as requested by study leadership or 
CSP Central Office.  These audits may be scheduled or unannounced.  
 
The purpose of these site visits is to encourage and assess compliance with Good Clinical 
Practice requirements.  Monitors/Auditors will examine participant study files including source 
documents in both the clinic files and the participants’ official VA medical records and will also 
review regulatory/essential documents such as correspondence with the VA’s Central IRB and 
Sponsor (CSP).  Areas of particular concern will be participant informed consent issues, protocol 
adherence, safety monitoring, VA’s Central IRB reviews and approvals, regulatory documents, 
participant records, drug accountability and site investigator supervision and involvement in the 
trial.  Reports will be prepared following the visit and sent to the LSI.. In addition, the CSPCC in 
collaboration with SMART will monitor study sites remotely through weekly reports, data 
queries and SC/LSI conference calls. 
 
• GCP Training 
All study team members will be required to complete the animal trainings online at CITI 
(Collaborative Institutional Training Initiative) (https://www.citiprogram.org/) at the interval 
required by the Office for Research and Development for animal research personnel for the 
duration of the study and the on-line CITI training or ORD equivalent prior to assuming their 
role on the study and then every two years thereafter for the duration of the study.  If additional 
sites are added or there is turnover in personnel, any new team members must satisfy the same 
requirements as delineated above for the primary SI or primary SC. Written verification of 
GCP/HSP training of study site personnel will be submitted to the CSPCC prior to the start of 
patient enrollment at each site.     
 
 
• Animal Training 
All team members at each site, including the site PIs and the study chairperson will be required 
to complete the animal trainings online at CITI (Collaborative Institutional Training Initiative) 
(https://www.citiprogram.org/) every year for the duration of the study. They will also be 

 
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required to complete the Veteran-oriented Dog Care Modules (also offered online at CITI) so 
they will be familiar with what education participants have received. Courses will include 
‘working with the IACUC’ and ‘Introduction to Dogs’.   If additional sites are added or there is 
turnover in personnel, any new primary SI or primary SC will be required to take the on-line 
CITI training or ORD equivalent prior to assuming their role on the study.  Written verification 
of GCP/HSP training of study site personnel will be submitted to the CSPCC prior to the start of 
participant enrollment at each site.   
 
• Summary of Monitoring and Auditing Plans 
a. Monitoring Visits  
(1)  Initiation visits at each site soon after study start-up 
(2) Additional monitoring visits may be conducted as deemed necessary by study 
leadership or SMART. 
 
b. Audits  
(1) Routine audits – independent site visits to one or more sites as determined by 
SMART.  
(2) For-Cause audits –independent audit of a site as requested by study leadership 
or CSP Central Office.   
(3) Audits may be scheduled or unannounced.

 
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XVIII. BIOSTATISTICAL CONSIDERATIONS 
 
• Study Design and Outcome Measures 
This is a longitudinal randomized trial, with two randomized arms which will follow participants 
with PTSD for 18 months post-pairing to examine how the provision of a Service Dog or 
Emotional Support Dog impacts their function by assessing longitudinal change in functioning 
over time.  The treatment arms consist of participants with PTSD partnered with Service Dogs 
(SERV) and participants with PTSD partnered with Emotional Support Dogs (EMOT).   
 
Following initial screening for inclusion criteria, randomization, and baseline assessment 
collection, participants will be enrolled in the observation phase of the study.  The participant 
will remain in the observational phase for at least three months.  After a participant has 
completed the observational phase and a dog is available, they will have the clearing visits where 
eligibility will be reconfirmed and assessment data will be collected.  The participants will be 
assessed for functioning, mental health, psychosocial well-being, and socioeconomic and 
healthcare utilization characteristics.  The minimum time for the observation phase is 3 months; 
however, this phase could be considerable longer depending upon the wait time for a Service or 
Emotional Support Dog to be ready for the randomized participant.  During this time, all 
participants will be attending a dog care class and must pass a dog care test on dog care.   
 
Following clearing, data will be collected at one and two weeks, one and two months and at 3, 6, 
9, 12, 15 and 18 months post pairing.  Participants will be assessed on activity limitations, 
quality of life, psychosocial well-being, dog-related information, socioeconomic and healthcare 
utilization characteristics over time.  For this study, activity limitations will be assessed at 
specific time points during screening, clearing and follow-up will be assessed by the WHO-DAS 
2.0 and the Medical Outcomes Study 12-Item Short Form that has been adapted for use in 
military participants (VR-12). Additional outcomes in mental health, healthcare utilization, 
health care costs, and employment/productivity will also be included. 
 
The primary objective of this study is to determine how the provision of a Service Dog or an 
Emotional Support Dog impacts activity and quality of life for participants with PTSD.  
Primarily, the objective is to compare activity limitations and quality of life change, relative to 
baseline, over the 18-month intervention period between the two groups of participants with 
PTSD, i.e., those who receive Service Dogs and those who receive Emotional Support Dogs.  
There are two primary outcomes in this study:  1) improvement in activity as assessed by the 
total WHO-DAS 2.0 score and 2) improvement in quality of life as assessed by the Physical 
Component Scale (PCS) and Mental Component Scale (MCS) of the VR-12.  The outcome 
measure for the first primary objective will be the change in the WHO-DAS 2.0 score over the 
18 month of intervention phase adjusted by baseline scores.  The outcome measures for the other 
primary objectives will be the relative change in the PCS and MCS scores over the 18 month of 
intervention phase adjusted by the baseline scores.  
 
The secondary and tertiary outcomes in this study are: 1) a reduction in PTSD symptoms as 
measured by the PTSD Civilian Checklist (PCL-5) 2) improvement in depression as measured 
by PHQ-9, 3) improvement in sleep as measured by the Pittsburgh Sleep Quality Index (PSQI), 

 
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4) decreased thoughts of suicide as measured by the Columbia-Suicide Severity Rating Scale 
(C-SSRS), 5) to characterize and compare how healthcare costs and utilization are impacted, 6) 
improvement in employment and productivity. 
 
Sample Size  
 
The three primary outcome measures for the proposed randomized trial are the: 
1. 
WHODAS 2.0 score, 
2. 
Physical Component Score (PCS) calculated from the VR12, and 
3. 
Mental Component Score (MCS) calculated from the VR-12 
 
Currently there are no randomized studies, which have been conducted on the provision of 
Service Dogs and Emotional Support Dogs for the treatment of Veterans with PTSD.  Therefore, 
this would be the largest study and first multi-center trial to date.  When reviewing the 
parameters for determining sample size for this study, the planning committee discussed the 
treatment group differences that would need to be found in the WHODAS 2.0, MCS and PCS 
primary outcome measures that would be meaningful from both a clinical standpoint and from 
the view of the  participant. 
 
The overall goal of this proposed study is to compare the two treatment groups: Emotional 
Support Dogs (EMOT) and Service Dogs (SERV) with respect to two specific outcomes – 
activity limitations and quality of life over 18 months of follow-up.  While both treatment groups 
are expected to show improvement just by virtue of participating in this treatment trial, the 
committee decided that a 10-point difference in the WHO-DAS 2.0 score would need to be found 
between treatment groups to be clinically significant.  The committee also determined that 
individual changes of 1 standard deviation (SD) on the PCS and 1 SD on the MCS (Kearney, et 
al., 2012) would constitute an improvement in both of these measures. 
 
By examining current data, the committee determined that using a 10-point difference between 
groups in the WHO-DAS 2.0 total score and a change of 15% in PCS and MCS would be 
conservative estimates of the sample size needed.  To calculate sample size, data from two on-
going CSP studies were used as an estimate of WHO-DAS 2.0 mean scores and SD.  Data from a 
study used to assess outcomes in participants who participated in a mindfulness-based stress 
reduction program were used as the PCS and MCS mean and SD (Kearney, 2012). 
 
TABLE 6:  Sample Size Estimates (α=0.05) per Treatment Group* 
 
Outcome by Power (1-β) 
 
(Control Group Mean and Standard Deviation) 
  
 
 
 
Power (1-β) 
 
 
 
 
WHO DAS 2.0 
 
MCS 
 
PCS 

 
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EMOT Group 
Mean  (S.D.) 
 
SD=13 & Mean 
difference 
between groups  
 
 
33.2 (10.6)** 
 
 
39.8 (10.8)** 
 
 
 
 
 
Change from EMOT Group Mean: 
 
5 point 
 
10% 
 
10% 
 
0.80 
0.85 
0.90 
 
 
 
 
108 
123 
144 
161 
185 
216 
117 
134 
156 
 
 
 
 
 
7 point 
 
15% 
 
15% 
 
0.80 
0.85 
0.90 
 
 
 
 
56 
63 
74 
72 
82 
96 
53 
60 
70 
 
 
 
 
 
10 point 
 
20% 
 
20% 
 
0.80 
0.85 
0.90 
 
 
 
 
28 
32 
37 
41 
47 
55 
30 
35 
40 
*   SD from CSP 579  
**  Kearney et. al, 2012 
 
In order to detect a 10-point difference in treatment group mean scores for the WHO-DAS 2.0 
over the 18 months of follow-up, at a statistical significance level of 0.05 (two-tailed test) and a 
power of 0.85, 32 participants per group will be needed (see Table 6).  In order to detect a 15% 
difference in mean scores for MCS over the 18-months of follow-up, at a statistical significance 
level of 0.05 (two tailed test) and a power of 0.85, 82 participants per group will be needed (see 
Table 6).  In order to detect a 15% difference in mean scores for the PCS over the 18-months of 
follow-up, at a statistical significance level of 0.05 (two tailed test) and a power of 0.85, 60 
participants per group will be needed (see Table 6). The sample size estimates were obtained 
using the PC-software SAS 9.2. 
 
Assuming the largest of the three sample sizes, 82 participants per group, and a maximum of 
25% participant loss or dropout rate a sample size of 110 participants per treatment will be 
required for this study.  To obtain the necessary sample size of 220 participants, at least three VA 
medical centers will be recruited.    Once a participant has been determined to be eligible for the 
study at the participating VA medical center, randomization to one of the two groups will be 
accomplished by a telephone call to the Perry Point Coordinating Center. All sites will be 
encouraged to recruit and enroll participants faster than the stated requirements.  
 

 
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• Statistical Methods 
The intent-to-treat population (ITT) is defined as the population of participants who will be 
randomized in either the Service Dog (SERV) or Emotional Support Dog (EMOT) treatment 
groups. The participants will be categorized based on their initial randomized group assignment 
and will be included in analyses irrespective of their status – completer or drop out of the study 
before completion. A per protocol population (PP) is defined as the population of participants 
who are paired with a dog.  Analyses of all outcome measures – primary and secondary – will 
use both the ITT and PP population.  
 
All statistical tests will be 2-sided and at 5% level of significance. SAS 9.2 or higher will be used 
to conduct all statistical analyses.  Initial analysis of all hypotheses will involve the examination 
of simple descriptive statistics.  Frequencies and proportions will be reported for all categorical 
variables.  Continuous variables will be described with either means and standard deviations or 
medians and other percentiles depending on whether or not the variables are approximately 
normally distributed.  In some instances, simple descriptive statistics will be the primary 
statistics of interest.  In most cases, these will be preliminary to the analyses described below.  
 
• Primary Outcome Measures 
Activity Limitations:   The WHODAS-2.0 was developed to assess disability related to physical 
and psychiatric disorders experienced within the past 30 days and provides a profile of 
functioning across six activity domains: understanding and communicating, mobility, self-care, 
getting along with others, life activities, and participation in society, as well as an overall 
summary score.    WHO-DAS 2.0 summary scores can range from 0 (no disability) to 100 (full 
disability).  The level of activity will be based upon the WHO-DAS 2.0 Summary Score 
measured at baseline, clearing, and 3, 6, 9, 12, 15 and 18 months post-pairing.   To begin the 
analyses, the mean and standard deviation of the activity level will be calculated separately, at 
each time point, for participants assigned to the Service Dog group and the Emotional Support 
Dog group.  We hypothesize that participants who receive Service Dogs will have decreased 
activity limitations over time, as compared to participants who receive an Emotional Support 
Dog. 
 
For this hypothesis, a linear repeated measures mixed model will be used to determine changes 
over time between groups. Thus the level-1 units consist of the repeated measures, WHODAS 
2.0 score, for each subject, and the level-2 unit is the individual or subject. In addition to 
estimating overall parameter estimates, multilevel modeling for repeated measures allows 
regression equations at the level of the individual (Curran, 2010).  WHODAS 2.0 summary 
scores will be considered as the dependent variable. Other variables found to be potential 
confounders will also be included in the model as covariates.  The use of mixed models allows 
for control of covariance data expected in clustered and repeatedly sampled data, and missing 
data.   
An additional analysis for this hypothesis will use the linear repeated mixed models, with 
random intercepts.  When random coefficients are specified, each subject has its own regression 
equation, making it possible to evaluate whether subjects differ in their means and/or response 

 
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patterns over time.  The WHODAS 2.0 summary scores will be regressed on time and the group 
x time interaction with random intercepts added for participants that will account for the 
correlation among repeated measures. 
Quality of Life:  The outcome measure for hypothesis 1-1b will be a summary measure of 
mental health status as measured by the Mental Component Summary (MCS) from the Veterans 
RAND 12-Item Health Survey (VR-12) instrument and a summary measure of physical health 
status as measures by the Physical Component Summary (PCS) from the VR-12.  The VR-12 is a 
brief, generic, multi-use, self-administered health survey comprised of 12 items.  The VR-12 was 
developed using extensive research from the VR-36 in the Veterans Health Administration 
(VHA).  The scoring of the PCS and MCS for the VR-12 is based on weights   derived from the 
VR-36 instrument administered to 1.4 million Veteran enrollees with 877,775 respondents in the 
1999 Large Health Survey of Veteran Enrollees (Veterans Health Study) (Iqbal, 2009)  Higher 
PCS and MCS scores reflect greater quality of life.  To begin the analyses, the mean and 
standard deviation of the PCS and MCS will be calculated separately, at each time point, for 
participants who were assigned to the Service Dog group and the Emotional Support Dog group.  
We hypothesize that participants who receive Service Dogs will have improved quality of live 
over time, as compared to participants who receive and emotions support dog. 
 
As described above, a linear repeated measures mixed model will be used to determine changes 
over time for the PCS and MCS between groups. There will be two separate models, one where 
the PCS will be considered as the dependent variable and a separate model where the MCS 
summary score will be considered as the dependent variable. Other variables found to be 
potential confounders will also be included in the model as covariates.  Additionally, a linear 
repeated mixed models, with random intercepts will be computed.   
 
• Secondary and Tertiary Outcome Measures 
Secondary continuous variable analyses will include linear repeated mixed model analysis on 
PTSD Symptom Severity using PCL-5, depression, sleep and thoughts of suicide.  Additionally 
all outcome measures will be examined separately for the observation phase and post-pairing 
phases of the study.  The basis for this analysis is to understand the characteristics of the 
population in the measures we have selected in their current level of care.   
 
Open-ended questions are asked in the Dog Related Questionnaire. The purpose of these 
questions is to obtain information about the human-animal bond that occurs for participants that 
have PTSD and are paired with a SERV or EMOT. The questions will be entered as text based 
fields into the database. Two assessors will independently review and categorize the data. The 
assessors will then meet to review their categories. Discrepancies will be discussed with a third 
assessor to result in consensus of the responses. The categorized responses to these questions 
will help guide future planning needs, if a program is implemented.  Additionally, qualitative 
measures of symptom status may be developed that are specific to the population of participants 
that are paired with a Service Dog or Emotional Support Dog.  These qualitative measures may 
be developed as the study progresses by use of focus group or questionnaires. 
 

 
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A complete discussion of the study's statistical monitoring and data analysis is contained in the 
Statistical Analysis Plan.   
 
• Economic Outcome Measures 
To characterize and compare how health care utilization and costs are affected by the provision 
of a Service Dog or Emotional Support Dog, cost and utilization will be assigned to each 3 
month period following study enrollment. 
 
Multivariate regressions will be used to evaluate the effect of assignment to intended treatment 
and quarter after enrollment to cost and utilization. Generalized Linear Model (GLM) 
regressions will be used as these avoid the inappropriate assumption of normal distribution and 
homoscedastic errors (Manning et al., 2001). A Box-Cox regression will be used to identify the 
appropriate link function (Box & Cox, 1964). A modified Park test will be used to identify the 
appropriate distributional family. It is likely that these will identify negative binomial regression 
for the utilization, and a gamma regression to analyze quarterly costs.   Standard errors will be 
corrected for the correlation of multiple observations from the same trial participant over time.  
 
For the employment and work productivity hypotheses, the Work Productivity and Activity 
Impairment Questionnaire: General Health Problem V2.0 (Reilly et al, 1993).  will be utilized.  
Work productivity will be characterized as Overall Work Productivity (OWP), which is a 
continuous variable bounded at 0 and 1.  OWP is calculated as (Reilly et al, 1993): 
 
OWP = % of Work time spent Working * % Productivity at Work 
 
The % of Work time spent Working is calculated as the number of hours worked divided by the 
sum of the number of hours worked and the number of hours missed work due to health 
problems.  These components are specifically queried by the Work Productivity and Activity 
Impairment Questionnaire V2.0 (WPAI V2.0).   
 
The WPAI V2.0 queries respondents about their productivity at Work by asking, “During the 
past seven days, how much did your health problems affect your productivity while you were 
working?” Respondents answer the question by choosing an integer ranging from 0 to 10.  The 
% Productivity at Work will be calculated as: 
 
% Productivity at Work = (Respondent’s answer/10) *100 
 
 
The WPAI V2.0 also queries respondents about ability to engage in regular daily activities.  
Respondents are asked, “During the past seven days, how much did your health problems affect 
your ability to do your regular daily activities, other than work at a job?” Respondents who are 
not formally employed will have their % Productivity for Activities of Daily Living (ADL) 
calculated as the following: 
 
% Productivity for ADL = (Respondent’s answer/10) *100 
 

 
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Multivariate regressions will be used to evaluate the effect of assignment to intended treatment 
and quarter after enrollment on employment and on overall work productivity.  Generalized 
Linear Model (GLM) regressions will be used, with Box-Cox regression used to identify the 
appropriate link function. A modified Park test will be used to identify the appropriate 
distributional family.  Standard errors will be corrected for the correlation of multiple 
observations from the same trial participant over time. Two sets of analyses will be run for 
productivity.  The first set of analyses will focus on work productivity and assign a value of 0% 
productivity to any individual who is not employed.  The second set of analyses will focus on 
overall productivity and will use % Productivity at Work as a data point if the respondent was 
formally employed and % Productivity for ADL as a data point if the respondent was not 
formally employed.  
 
• Missing Data 
For this study we will collect data by in-person interviews and home visits, therefore we expect 
minimal missing data.  When missing data are encountered in the analyses, a detailed sensitivity 
analysis can be conducted of the effects of various assumptions about the missing data.  When 
needed, missing data will be imputed using standard multiple imputation techniques. 
 
 
• Interim Monitoring 
An independent oversight committee, a Data Monitoring Committee (DMC) will be monitoring 
study progress at predetermined time points over the entire duration of the study. The committee 
will receive analyses of the primary and the secondary outcome measures on a routine basis.  
Additionally, the committee will receive data on the participants enrolled, description of the 
reasons for participant exclusion, adverse events and each centers performance with regard to 
participant intake and follow-up.   In general, this committee meets at six to nine months after 
the start of participant recruitment and at least annually (sometimes semiannually) thereafter. 
The committee will receive reports about three weeks prior to the meetings. Since the primary 
outcome measures are at 18 months, sufficient data for DMC’s first review will not be available 
until the study has been ongoing for at least two years.  
 
• Criteria for Study Termination 
The DMC determined at their initial meeting that they would not utilize an interim analysis of 
the primary outcome to determine stopping rules.  Instead they will analyze the safety data from 
the study, including AEs and SAEs, to determine if the study should terminate.  This will 
continue throughout the study.

 
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XIX. STUDY ORGANIZATION AND ADMINISTRATION 
 
• Requirements for Participating Medical Centers 
All participating medical centers must be willing and able to adhere to the study protocol.  
Minimum requirements for participating medical centers will include: 
 
1. Site Investigator.  The site investigator will be an individual with a clinical degree (e.g. 
psychologist, psychiatrist, nurse) who agrees to support the study enthusiastically and 
devote sufficient time and energy to ensure that recruitment goals are achieved and that 
study participants are followed appropriately.  The Site Investigator will have at least a 
5/8 VA appointment. 
2. Local Study Coordinator.  The site investigator will recruit a local study coordinator to 
assist in all aspects of study conduct including recruitment, participant monitoring, and 
assistance with all study procedures.  Experience in the conduct of clinical investigation 
is highly desirable.  The local study coordinator is expected to work diligently with the 
site investigator to meet the goals of the study.  In addition, the local study coordinator 
will be expected to work collaboratively with the staff at the Chairman’s office and the 
CSPCC. 
3. Administrative Support.  Each site must provide a letter from the Director and/or the 
Chief of Staff ensuring that the Site Investigator will receive full administrative support 
during the conduct of this study.   
4. Local Approvals and Reporting Requirements.  Sites will be required to agree to allow 
the VA Central IRB to be the primary IRB for the study and agree to use the VA Central 
IRB’s informed consent template updated only for site specific items in the template 
(e.g., names of the Site Investigator).  Site Investigators will be responsible for 
coordinating the medical center’s interactions with the VA Central IRB.  All sites will 
require Research and Development Committee approval of the study, and some sites may 
still require local IRB approval.  The Site Investigator will be responsible for obtaining 
initial approval for the protocol and the informed consent form from his/her VA medical 
center’s Research and Development Committee and from the Human Studies 
Subcommittee/IRB. Copies of the minutes for the meeting documenting approval by 
these committees or a letter from the Chair of the appropriate Committee stating when the 
Committee met, what their concerns were, and their final recommendation, will be 
submitted to the CSPCC before any participants are enrolled at the local center.  It will be 
the responsibility of the Site Investigator to maintain continuing approval of the protocol 
at the local site.  Documentation of this continuing approval will be submitted to the 
CSPCC. 
5. Institutional Animal Care and Use Committee (IACUC). All site investigators will be 
responsible for obtaining approval of their local IACUC.  All site investigators will be 
provided a copy of the Animal Component of Research Protocol (ACORP) for 
submission. The approved ACORP will be submitted to the site PI’s R&D office for 
approval. Site Investigators must provide approval letters to CSP once obtained.   
6. Global Monitoring and Reporting Responsibilities Delegated.  By agreeing to participate 
in the study, centers delegate responsibility for global monitoring of the ongoing study to 
the VA Central IRB, DMC, HRC, CSSEC, CSPCC, and the CSPCRCPCC.  In addition, 

 
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the local Research and Development Committee and the local Human Studies 
Subcommittee/IRB will require the Site Investigator to submit annual reports concerning 
the status of the study for local monitoring purposes. 
 
• Number of Participating Medical Centers 
There will be an 18-month period during which to recruit 220 total study participants.  There are 
numerous exclusion criteria that will limit participant eligibility, along with the availability of 
service and companion dogs. Furthermore, the numerous study procedures that will be required 
are labor intensive and will be time consuming for the site investigators and local study 
coordinators.  This limits the number of participants that reasonably can be followed at any one 
medical center.  We feel that a three-site study in which each site is expected to consent 
approximately 100 participants in order to obtain the overall goal of 220 pairings  is realistic and 
highly feasible.  We should easily be able to meet recruitment and follow-up goals with three 
participating medical centers. 
 
• Available Participants at each of the three proposed sites 
Three sites have been selected.  Each site has provided an estimate of the potential participant 
population that could potentially be recruited. It was not possible to determine how much of the 
population at each site met all inclusion/exclusion criteria.  
 
1. VA Portland Health Care System 
3710 SW US Veterans Hospital Road 
Portland, OR 97207 
 
Between June 1, 2012 and May 31, 2013 the VA Portland Health Care System 
(VAPHCS) PTSD Treatment Team (PCT) recorded 10,712 encounters with 1549 
unique Veterans, for an average of 129.1 unique Veterans diagnosed with PTSD per 
month receiving treatment services from the VAPHCS PCT over that time interval.   
 
2. Atlanta VA Medical Center 
1670 Clairmont Road 
Decatur, GA 30033 
 
In Atlanta, there are approximately 40 consults per week seen (160 consults per 
month).  Using FY13 data to this date (Oct 2012-June 2013), staff provide services to: 
816 unique Veterans per month in the 540 (individual) stop code and 250 unique 
Veterans per month in the 561 (group treatment) stop code.  There is probably some, 
but not total, overlap between these two, so it is reasonable to estimate 1000 unique 
Veterans per month are seen by the  by the Atlanta VAMC PTSD Treatment Team.   
 
3. Iowa City Veterans Affairs Health Care System 
    601 Highway #6 West 
    Iowa City, IA 52246 
 

 
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Iowa City Veterans Affairs Health Care System fields 3800 unique Veterans with PTSD 
per year of which 10% are referred to PTSD orientation.  During FY13 (10/1/12-9/30/13) 
there were 3792 unique visits for patients coded with 309.81 POSTTRAUMATIC 
STRESS DIS.  
 
 
•  Study Management 
CSPCC.  The Perry Point Cooperative Studies Program Coordinating Center (CSPCC), located 
in Perry Point, Maryland, will provide administrative, data processing, and statistical support for 
the study. All data forms will be submitted to the CSPCC for processing. The CSPCC will edit 
the data and create the study database.  CSPCC staff will provide guidance on completion of 
forms. All reports during the ongoing phase of the study and the final statistical analyses will be 
the responsibility of the CSPCC.  CSPCC staff will also monitor study progress to ensure that the 
study is proceeding as scheduled.  A CSPCC study team dedicated to this study has already been 
established.  This team will be headed by the study biostatistician and will include a CSPCC 
project manager, a statistical programmer, a database programmer, and two computer assistants. 
 
Office of the Chairman.  The chair will provide leadership for the study. All questions and 
concerns of a technical nature will be addressed by the Chair’s office. The Chair will be in 
routine contact with the participating centers to ensure that the study is performed in accordance 
with the protocol and to encourage the local study team to keep enrollment and follow-up 
activities on schedule.  The Study Chairmen will preside over all meetings of study participants 
and will represent the study, along with the study biostatistician, at all meetings of outside 
review committees. The Chairman’s Office will be funded with a full-time national study 
coordinator (1.0 FTE). The chair, in collaboration with the CSPCC and CSPCRPCC, will be 
responsible for all study executive decisions and will serve as the Chairman of the Executive 
Committee.   
 
National Study Coordinator. The national study coordinator is responsible for maintaining 
enthusiasm for the study at all sites, discussing problems of mutual interest related to the study, 
and identifying any procedural/definitional modifications that might be required.  The national 
study coordinator will be responsible to oversee all study activities in the Chairman’s Office on a 
day-to-day operational basis. Specifically, the national study coordinator will:  
 
1. Assist the Study Chairperson in coordinating and administering all aspects of the study; 
2. Assist the Study Chairperson in monitoring the progress of the study; 
3. Maintain close contact with the participating research teams and assist them in any 
procedural details of the study:  
4. Maintain close contact with the study’s supervisory committees; and  
5. Work collaboratively with the Perry Point CSP Coordinating Center team to organize and 
plan periodic meetings of participating study teams  for the purposes of reporting 
progress of the study.  
 
National Dog Trainer and Local Dog Trainers:  The national dog trainer will be responsible for 
overseeing the site dog trainers and will be ‘proofing’ all of the dogs that will be accepted by the 

 
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VA as part of this study.  The national dog trainer will also assist in the development of the Dog 
Care Course and Exam.  The local dog trainers will be responsible for the local activities 
including teaching and remediating students in the dog care class, performing home visits, and 
ensuring that the SERV and EMOT dogs are maintained during the randomization phase of the 
study.  The local dog trainers will also be responsible for teaching the local obedience classes for 
the EMOT pairings. 
 
Site Data Manager:  The Site Data Managers will be responsible for assisting the Site 
Coordinators with data tracking activities.  The Site Data Managers will assist with data 
collection as well as tracking Veteran’s appointments and payments, conducting home visits and 
verifying that all data are collected at the appropriate time. 
 
CSPCRPCC. The Cooperative Studies Program Clinical Research Pharmacy Coordinating 
Center, located in Albuquerque, New Mexico, will be responsible for monitoring adverse events 
and serious adverse events. 
 
HERC.  The Health Economics Resource Center, located in Menlo Park, CA will be responsible 
for conducting the healthcare utilization, cost, employment, and work productivity analyses. 
 
Study Sites.  The site investigator at each of the participating medical centers will be responsible 
for all aspects of the study at his/her site.  This includes participant recruitment and follow-up, 
obtaining initial and yearly local R&D Committee and IRB approvals, ensuring adequate 
coverage for the study in his/her absence or the absence of other study participating staff, and 
ensuring the integrity of the study protocol and data from his/her site.  A local study coordinator 
will be funded for each site and the site investigator will be responsible for hiring and 
supervising this person.  In no case should any local study coordinator be assigned duties not 
related to this study.  The primary goal for this position is successful recruitment, explaining 
informed consent, gathering data, and coordination of follow-up assessments.  Funding for this 
position may be terminated or reduced if insufficient participants are recruited and/or data 
collection and follow-up are deemed to be unsatisfactory.  Each local study coordinator will 
work with the national study coordinator to develop and to implement a recruitment plan.  The 
local study coordinator at each site will participate in periodic conference calls with the other 
local study coordinators and other study staff.   
 
• Monitoring of the Study  
1. 
Monitoring bodies 
 
The groups charged with monitoring the various aspects of the study will be the Executive 
Committee, the Data Monitoring Committee (DMC), the VA’s Central IRB, and the Perry Point 
Human Rights Committee.  These committees will meet at regular intervals according to the 
current Cooperative Studies Program guidelines: prior to the beginning of participant intake and 
at least every twelve months thereafter.  In addition, the CSP Site Monitoring, Auditing and 
Resource Team (SMART), located at the CSP Clinical Research Pharmacy Coordinating Center 
(CSPCRPCC), will monitor the trial for GCP compliance.  

 
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The Executive Committee is the management and decision-making body for the operational 
aspects of the study and will monitor the performance of participating medical centers and the 
quality of data collected.  The Executive Committee will formulate publication plans and will 
oversee the publication and presentation of all data from the study.  The Committee must grant 
permission before any study data may be used for presentation or publication. 
 
The Data Monitoring Committee (DMC) will review the progress of the study and will monitor 
participant intake, outcomes, adverse events, and other issues related to participant safety.  The 
DMC makes recommendations to the Director of the Clinical Science Research and 
Development (CSRD) Service about whether the study should continue or be stopped. The DMC 
will consist of experts in the fields of PTSD, Service Dogs, clinical trials, biostatistics, and 
ethics.  These experts will not be participants in the trial and will not have participated in the 
planning of the protocol. The DMC will consider safety or other circumstances as grounds for 
early termination, including either compelling internal or external evidence of treatment 
differences or the unfeasibility of addressing the study hypothesis (e.g., poor participant intake, 
poor adherence to the protocol).    
 
At each of its meetings during the study period, the DMC will review the randomization rates 
and assess the difference between the actual and the projected rates, as well as the impact of 
these assessments on overall trial size.  If the study enrollment is inadequate, the reasons for 
exclusion may be scrutinized and actions may be suggested.  An assessment of whether the trial 
should be continued will be made followed by recommendations, as appropriate. All serious 
adverse events will be reported on a regular basis to the DMC for their review.  Unexpected 
serious adverse events will be reported to the DMC as soon as they become known based upon 
the consensus of the Study Chair, the Study Biostatistician, the Director, Perry Point CSPCC, 
and the Study Pharmacist.  The Study Biostatistician will provide the appropriate data to the 
DMC at specified intervals for this purpose.  Conditional power estimates will be provided to the 
DMC to assist them in making their decisions and recommendations.  
 
The VA’s Central IRB will be the study’s primary IRB and the IRB of record for the study.  It 
will be responsible for the initial and continuing IRB reviews of the study.  The VA Central IRB 
must review and approve amendments (changes to inclusion/exclusion criteria, protocols, 
informed consents, etc.), deviations, and review reports about adverse events and problems, 
complaints, terminations, etc. and that the investigation must provide the VA Central IRB all 
supporting documentation.  The CSPCC will be responsible for providing the VA Central IRB 
with all materials that are required for each review and to respond to the VA Central IRB’s 
queries and requests for additional materials.  The VA Central IRB approves the original 
informed consent template and any requested changes to the informed consent forms. 
 
The Human Rights Committee (HRC) at the Coordinating Center may be asked to convene if 
there is any serious adverse event requiring its attention.  
 
Site Monitoring Auditing & Resource Team (SMART) will conduct an initial site visit at each 
site soon after study start-up. Additional monitoring visits may be conducted as deemed 

 
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necessary by study leadership or SMART. Monitoring of sites participating in the trial will be 
executed according to Cooperative Studies Program (CSP) guidelines.  Independent routine 
audits will be conducted as determined by SMART.  For-cause audits will be conducted as 
requested by study leadership or CSP Central Office.  These audits may be scheduled or 
unannounced. The Study Group, which consists of all site investigators and local study 
coordinators, will meet annually to discuss the progress of the study and any problems 
encountered during the conduct of the trial.   
 
• Monitoring participant intake and probation or termination of participating sites 
The Study Chairs and the Study Biostatistician will monitor the intake rate and 
operational aspects of the study.  Participating medical centers will continue in the study only if 
adequate participant intake is maintained.  The Executive Committee may take action leading to 
the discontinuation of participant enrollment at a center with the concurrence of the CSPCC 
Director. If recruitment is not proceeding at an appropriate rate, the Study Chair and Study 
Biostatistician will scrutinize the reasons for participant exclusions.  Based on this information, 
the Executive Committee may choose to drop centers or add additional centers, or to make minor 
modifications to the inclusion/exclusion criteria. The DMC and Director of CSRD will be 
notified regarding the dropping or adding of centers. The Executive Committee will only take 
actions leading to discontinuation of a center with the concurrence of the CSPCC Director. If a 
center is terminated from the trial, resources will be reallocated to other centers or used to start 
up a backup site. 
 
• Monitoring data quality and protocol adherence 
Each participating site will be monitored for data quality, completeness of follow-up and 
adherence to the protocol. Regularly scheduled conference calls (at least monthly) with the sites, 
CSPCC and Chairman’s office will be held to address data collection, protocol procedures and 
other issues. Strict adherence to the protocol will be expected of every participating center and 
will be monitored by the DMC, the Executive Committee, and the CSPCC.  Documentation of 
protocol breaches will be required and any medical center with repeated protocol violations will 
be recommended to the Executive Committee for termination.  If a participating site investigator 
feels that adherence to the protocol will in any way be detrimental to a particular participants’ 
health or well-being, the interest of the participant must take precedence. In addition, CSPCC, 
the Executive Committee and the DMC will monitor protocol adherence centrally. The 
Executive Committee will consider recommending a for-cause GCP audit be conducted by 
SMART for any site with repeated protocol violations and will consider terminating the site from 
the trial.  
 
Data quality and the completeness of data retrieval will be closely monitored on an ongoing basis 
by the Coordinating Center. The study biostatisticians will present interim monitoring reports to 
the Executive Committee and the DMC that will include the following types of information:  
• Participant intake 
• Randomization errors 
• Breaches of protocol 
• Adherence and compliance with original treatment assignment 

 
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• Missed study visits 
• Completeness of follow-up 
• Data quality: data query and error rates 
• Audit and site visit results. 
 
If a site is identified as an outlier in terms of data quality, a site conference call or site visit will 
be initiated to assess the reasons why problems are occurring and how they can be corrected. If 
the problems continue, the site may be placed on probation or terminated from the study. 
 
• Monitoring of safety, efficacy and futility 
As previously noted, the DMC will review the accumulating data and be responsible for 
determining whether or not to recommend that the trial be stopped for efficacy, futility or safety. 
Data summaries will be prepared for the DMC for these purposes. Frequent summaries of 
adverse events will be prepared for the DMC for the monitoring of safety, e.g., annually or semi-
annually. To aid the DMC in their deliberations, other relevant information inside (e.g., 
secondary analyses) and outside (e.g., other studies) will be made available. Complete details of 
the interim monitoring plans for the study are given in Section XVIII:  Biostatistical 
Considerations.

 
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XX. 
PUBLICATIONS 
 
• Publication of Research Results 
It is the policy of the Cooperative Studies Program not to reveal outcome data to site  
investigators until the data collection phase of the study is complete.  This policy is meant to 
prevent possible biases that might affect data collection.  Members of the DMC and the CSPCC 
Human Rights Committee will be reviewing outcome results to ensure that the study will be 
terminated early if a treatment is identified as prohibitively dangerous or if a definitive answer is 
reached prior to the scheduled study termination date.   
 
All presentations and publications resulting from this study will follow CSP policy as specified 
by the CSP guidelines.  The presentation or publication of any or all data collected by site  
investigators on participants entered into a Department of Veterans Affairs Cooperative Study is 
under the direct control of the study’s Executive Committee.  No individual site investigator has 
the right to use this study’s data to perform analyses or interpretations, or to make public 
presentations or seek publication of any or all of the data without the specific approval of the 
Executive Committee.  
 
The Executive Committee has the authority to establish any number of publication committees, 
which usually will comprise subgroups of site investigators and some members of the Executive 
Committee, for the purpose of producing manuscripts for presentation and publication.  Any 
presentation or publication related to this study should be circulated to site investigators for 
review, comments and suggestions at least four weeks prior to submission of the manuscript to 
the presenting or publishing body.  
 
All publications must give proper recognition to the funding source and should list all study 
participants (not necessarily as authors of the manuscript).  If a site investigator’s major salary 
support and/or commitment is from the VA, it is obligatory that the site investigator lists the VA 
as his/her primary institutional affiliation.  Submission of manuscripts or abstracts must follow 
the usual VA policy; ideally, a subtitle states, “A Department of Veterans Affairs Cooperative 
Study.”  The CSP also requires that every manuscript be reviewed and approved by the CSPCC 
Director prior to submission as a final quality control step.  Mechanisms for appeal by a 
dissatisfied site investigator will follow procedures defined by the VA Office of Research and 
Development. 
 
Participation in Department of Veterans Affairs Cooperative Studies is voluntary.  Any site 
investigator who cannot accept these operation guidelines regarding publication policy should 
not volunteer to participate in the study. 
 
• Planned Publications 
Upon completion of the study, manuscripts will be prepared that focuses on the following 
objectives:   
• The challenges of doing research on animals and humans: lessons learned. This paper 
will summarize the challenges faced by the research team over the course of the study. 

 
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• Does having a Service Dog improve community participation, reduce PTSD symptoms 
and quality of life over an Emotional Support Dog; This paper would examine 
differences between group (SERV vs EMOT  to the primary outcomes of  WHODAS, 
Quality of life (physical) and PCL) 
• Dogs preventing suicide intent: this paper would examine the findings between groups 
with the outcome of suicide scale and perhaps the other mental component summary. The 
cost benefit of Service Dogs compared to Emotional Support Dogs – this would compare 
the two groups to the healthcare utilization, medication use, etc.  
• 
A paper that focuses on the expectation of receiving a dog and how scores of the various 
measures change. 

 
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