Service Dogs for Veterans With PTSD: A Randomized Clinical Trial
Phase: NA
Conditions: PTSD
Sponsor: VA Office of Research and Development

 
 
 
 
 
  
Service Dogs for 
Veterans with PTSD: A 
Randomized Clinical Trial 
NCT01329341 
11/26/2014 

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1. 
Introduction to Application 
Not applicable 
 
2.  
Research Plan 
Specific Aims  
Service dogs (SDs) is an umbrella term that encompasses a variety of trained dogs which assist 
individuals with disabilities. The training of these dogs can vary – from highly trained medically-
necessitated service dogs to well-trained domestic pets that provide emotional support and 
comfort to their owners.  Although the benefits SDs afford their partners have been examined 
previously as a means to aid functional tasks, SDs may also provide constant companionship, 
enhanced feelings of personal safety, and serve as social connections with others. 1,2,3,4,5 
 
This proposed three-year, longitudinal study will follow individuals with PTSD newly partnered 
with SDs (SD Group). Participants will be recruited from the Tampa VA catchment.  All 
participants will be asked to complete questionnaire packets at baseline, three, six, nine, twelve, 
eighteen and twenty-four months after enrolling in the study.  
 
Research Questions and Hypotheses:  
Specific Aim 1: To determine the impact of service dogs and determine who benefits the most. 
Hypothesis 1A: Individuals partnered with SDs will have greater improved mental health 
over time (Primary outcome will be the PCL checklist. Secondary mental health will be 
quantified by scores on depression and alcohol use). 
 
Hypothesis 1B: Individuals partnered with SDs will have improvements over time in 
secondary factors of physical, psychosocial, and socioeconomic variables. The secondary 
factors are defined as follows: 1) physical factors: co-morbidities, medication use, sleep 2) 
psychosocial factors: community participation, quality of life and 3) socioeconomic 
factors: demographic and health care utilization and out-of-pocket health care expenses.  
 
Specific Aim 2: To determine costs associated with total health care utilization and mental health 
care utilization among Veterans with mental health disorders needs and service or therapy dogs. 
 
Hypotheses 2A: Individuals partnered with SDs will have decreased mental health care 
utilization over time.    
Hypotheses 2B: Individuals partnered with SDs will have decreased total health care 
utilization over time.  
 
Specific Aim 3: To determine recommendations for providing service dogs to Veterans.  
Develop a strategic plan to provide service dogs to Veterans. A consensus meeting will be 
planned and will include all investigators of the project along with key individuals from funding 
agency to discuss findings of study. 
 
Secondary Aim: To compare study findings to another VA funded study that is providing dogs as 
pets to Veterans with PTSD. Both studies are using similar measures to assess mental and 
psychosocial factors. Data will be compared across groups (SD to dog as a pet) to determine if 
the highly trained dogs help the Veteran more than having a dog as a pet.  

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Projected Time Table  
Training of SDs is time intensive and expensive, with limited numbers of dogs who actually 
graduate. We will work with vendors to obtain the dogs, but recognize that there may be a 
significant waiting period prior to pairing. To demonstrate maximum treatment benefits, the data 
collection phase of this three-year study will be conducted for a minimum 18 months (maximum 
of 24 months for early enrollees) as we feel the acclimation period for the human-animal bond is 
longer than 18 months. This  allows sufficient time for statistical analyses. 
 
Timeline 
TASK 
YEAR 1 
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YEAR 5 
 
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Start up activities, 
finalize data 
collection forms, 
hire and train data 
collectors 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Renewal training 
for data collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Advertisement/pro
motion of study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruit 
participants, 
collect baseline 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY HOLD** 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collect 3-, 6-,9-, 
12- 18- and 24-
month data on 
enrolled veterans 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Enter data in 
electronic 
database and 
conduct on-going 
verification 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct statistical 
analyses and 
summarize 
findings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Apply for 
additional funding 
to support follow 
up work 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination of 
Findings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prepare 
manuscripts 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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** Because of ongoing vendor issues, enrollment was stopped for a second time and new 
vendors have been awarded contracts. Study will extend beyond the three year period utilizing 
Veterans who signed consent prior to second hold.   
 
Background and Significance 
An estimated 16,000 individuals are partnered with SDs today. 6 In the early 2000’s, the cost of 
raising and training these highly skilled dogs, who typically work for eight years, is estimated to 
range from $8,500 to $15,000. 7, 8 Current estimates (from conversations from a variety of 
vendors) is around $23,000.  Section 2 of Bill H.R. 2792, the Disabled Veterans Service Dog and 
Health Care Improvement Act of 2001, allows the VA to reimburse costs of SDs and associated 
training for qualified Veterans. 9,10,11An additional bill was passed in 2010, Bill S.1390, sec 1084 
which  authorized appropriations to conduct a pilot program on use of service dogs for the 
treatment or rehabilitation of Veterans with physical or mental injuries or disabilities. This pilot 
program is to be implemented “120 days after the enactment of this Act, and a three year pilot 
program to assess the benefits, feasibility and advisability of using service dogs for the treatment 
or rehabilitation of Veterans with physical or mental injuries or disabilities, including post-
traumatic stress disorder (PTSD)” is to be completed.12 Due to the previous research conducted 
by the principal investigator (PI) of this proposal, the research team has chosen to focus on 
PTSD and subsequent mental health improvements which may result from provision of a service 
dog.  
 
Although some studies have been completed, the research that has been conducted to date has 
not been designed or controlled in ways that bring us closer to the use of SDs becoming 
empirically supported treatments. Study samples tended to be small, unrepresentative and 
heterogeneous, and without adequate control groups. In going forward, of utmost importance is 
the careful definition of the population under examination and what is to be measured, as well as 
a need for controlled designs and stated outcomes that are relatively impervious to expectancy 
and demand effects, and to self-report or personal interest biases. Additionally, most studies have 
reported on the positive benefits that are observed while in the context of the therapeutic milieu 
but have not examined whether these effects carry over into other contexts or if they are retained 
over time. Rigorous efficacy and effectiveness research is needed. 
 
Background of Service Dogs: The use of dogs to assist individuals with disabilities began over 
twenty years ago, and has subsequently flourished.13 According to the American with Disabilities 
Act (ADA), if a dog has been individually trained to ‘work or perform tasks for the benefit of a 
person with a disability’ it is considered a ‘service dog’.14 Furthermore the ADA defines 
disability as a ‘mental or physical condition which limits major life activity’ which would 
include items such as caring for one’s self, walking, seeing, hearing, working, and psychiatric 
conditions. The dog must be trained specifically to the person’s disability. Service animals 
(including SDs) are legally defined and are not considered ‘pets’.  International Association of 
Assistance Dog Partners (IAADP) includes Psychiatric dogs under the umbrella of service 
animals 15 Therapy animals are not legally defined by federal law. They are typically personal 
pets of their handlers and work with their handler to provide services to others. 16 Therapy dogs 
are typically used in facilities or as Animal Adaptive Therapy. Various service dog agencies, 
though train dogs to be companions to individuals with mental health disabilities and refer to 
them by a variety of names including skilled companion dog, special needs therapy dogs, and 

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social/therapy dogs. Presently an estimated 16,000 individuals use a SD for mobility related 
impairments. 15, 16 As limited research exists, the characteristics of this group are relatively 
unknown, including the distribution of disabilities and demographics of the population. 
Depending on the type of service dog, various aids are provided. For example, mobility SDs 
provide aid with mobility-enhancing and energy-saving tasks: pulling wheelchairs, assist with 
transfers, open doors, turn light-switches on and off, and retrieving objects (e.g., telephone, 
towels, clothing). 2,3,4,5 Psychiatric service dogs provide aid in assistance of a medical crisis, 
treatment related assistance, assistance coping with emotional overload, and security 
enhancement tasks.15 
 
Additional sections of this background focus on research that currently exists which justifies why 
we are examining certain outcomes. The remainder of the background section is divided into 
four sections encompassing 1) Mental Health and PTSD, 2) Mental Health and Service Dogs 3) 
Service dog impacts on secondary factors: Physical, Psychosocial, Economic and 4) Service dogs 
and Healthcare Utilization.  
 
Mental Health and PTSD:  Epidemiological studies with civilian populations, including  the 
largest of which is the National Co-morbidity Survey-Replication (NCR-S), show that the 
lifetime prevalence of PTSD is 6.8% in the United states, with women outnumbering men almost 
3-to-1 (9.7% women, 3.4% men). 17  Surveys of base rates for PTSD in military personnel 
returning from wars in Iraq and Afghanistan have yielded a wide range of estimates. Rates have 
varied considerably, but large, convenience samples of deployed veterans have in general ranged 
between 5-20% for PTSD in non-treatment seeking veterans, while studies looking at veterans 
who are seeking treatment report rates as high as 50% for veterans who screen positive for 
PTSD.18  
 
The Use of the Diagnostic Interviews and Instruments in PTSD Studies: The diagnosis of PTSD 
is reached when a trained clinician determines that the criterion for the disorder has been met 
according to agreed- upon symptoms. To aid in the reliable diagnosis of a psychiatric disorder 
structured clinical interviews have been developed which allow for increased agreement upon the 
classification of a diagnosis. The Clinician-Administered PTSD Scale (CAPS)19 has become the 
gold standard for classification and determination of PTSD in trauma populations.  It has been 
well validated has been used in hundreds of studies.20 
 
Methods to screen for PTSD, as used in the above studies on prevalence, can vary from as little 
as a few items (e.g. 4 items on the PC-PTSD21, to the 17 items on the PTSD Checklist (PCL) 
which directly relate to the symptoms needed for diagnosis).20 The screening instruments are 
extremely valuable, particularly when time, limited resources, or costs are factors that will not 
allow for a face to face clinical interview to be conducted. All such screening instruments are 
judged against the gold standard of the CAPS in determining how well they approach agreement 
in the reporting of symptoms or stating there is a case of PTSD present.  While all screening 
instruments vary somewhat from the highest standard of the structured clinical interview, the 
PCL has been found to be a well validated and reliable instrument when assessing symptoms of 
PTSD across time.22  
 

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In addition to PTSD, common co-morbid psychiatric conditions can frequently occur. Vietnam 
Veterans have most commonly reported problems with depression, anxiety, and alcohol, among 
Veterans who had high levels of war-zone exposure being significantly more likely than those 
with low exposure to develop the disorders. 23 Depression and alcohol problems have continued 
to be common among returning Veterans, with rates ranging from 14% to 27%. 24,25 A related 
study, evaluating mental health problems among 88,235 US soldiers returning from Iraq, showed 
that 20.3% of active and 42.4% of reserve soldiers required mental health treatment, including 
treatment for alcohol problems, and that many reported a fourfold increase in concern about 
interpersonal conflict in a period of 3 months post-deployment, namely with family and 
significant others. 
  
Mental Health and Service Dogs: Animal-Assisted Therapy (AAT), a form of SD, has been 
associated with a positive influence on individuals with psychiatric symptoms.26,27,28 Recent 
work by Anonioli et al, 29  demonstrated that subjects with depression randomized to interaction 
with dolphins (vs. no dolphin interaction) demonstrated significantly decreased depression scores 
following exposure. Columbo et al. 28 demonstrated that among three groups of the 
institutionalized elderly, the group randomized to animal therapy demonstrated significant 
increased quality of life and decreased symptomology. Berget et al.26 demonstrated in a 
randomized trial involving exposure to farm animals (vs. no exposure) among subjects with 
schizophrenia, anxiety order and affective disorders, the exposed group demonstrated 
significantly increased self-efficacy scores and quality of life scores. 
 
Although research exists to document that depression is at increased levels in disabled 
population compared to that of the general population,30 little of the SD research has assessed 
level of depression in study participants. Findings from previous grants conducted by the PI have 
shown that receipt of SDs, positively impacts the occurrence of depression. 31 In addition, 
Rintala et al.32 found individuals newly partnered with SDs to exhibit modest improvements in 
depressive symptoms over a 6-month period of time. Our study will use the PCL checklist as 
the main outcome and include measures of depression and alcohol use as additional 
primary outcomes. (Hypotheses 1A). 
 
Service dog impacts on secondary factors: Physical and Psychosocial: In the studies that have 
been completed to date on the use of SDs, the impact that SDs have on psychosocial outcomes 
have been examined at length. Most of the research conducted, has been completed on 
individuals who are using wheelchair SDs opposed to therapy dogs.   
 
Physical:  A similar relationship has been found for individuals who have PTSD. 33,34 In a recent 
sample of OEF/OIF veterans, a substantial number of Veterans who develop PTSD often have 
co-morbid chronic pain. One recent sample found that approximately 35% of chronic pain 
patients carry a diagnosis of PTSD,35 while in a study of patients with low back pain, 51% of the 
patients evidenced significant PTSD symptoms.36 A strong association has been found between 
the occurrence of pain, and problems with emotional and physical functioning in the returning 
OEF/OIF Veteran population.33 There is a strong need to consider how these factors impact 
overall functioning and how treatments, including medical and psychotropic medication are 
utilized.  
 

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There have been a number of studies, on Veterans with PTSD which have reported poorer 
physical health, increased medical utilization, and greater work impairment than those without 
PTSD. Other studies in a civilian female population37 found that the presence of PTSD accounts 
for significant functional impairment, beyond that of the physical aspect of the trauma. This was 
evident on measures of physical functioning, vitality social functioning and role limitations, with 
similar results in decreased general health, vitality and social functioning38  in patients who still 
met criteria for PTSD, one year after enduring physical traumas that required hospitalizations 
and surgery. These findings highlight the association between trauma, presence of PTSD and 
greater functional impairments, which is often present in our Veteran population. 
 
Psychosocial: Several studies have examined changes in self-esteem of individuals partnered 
with SDs. Rintala et al. found new SD partners (n=16) exhibited significant increases in self-
esteem. In a cross-sectional survey of SD partners (n=202) conducted by Fairman et al., 4 
participants self-reported increased self-esteem, confidence, safety and independence as well as 
better coping abilities.  
 
Individuals with disabilities are less likely to be able to fully participate in their communities.39, 
40 Excessive time spent in self-care and medical needs can limit the availability of, and energy to 
pursue, social and leisure activities. Eddy et al.41 observed the public’s behavior toward 
individuals using wheelchairs with and without their SDs. Significantly increased numbers of 
passerby smiles and initiated conversations were seen when the SD was present compared to 
when the dog was not present. These results were noted first with children and then with adults 
using wheelchairs in a variety of settings.41,42 Assistance animals serve as social buffers by 
alleviating discomfort and awkwardness according to these studies.  
 
 
       
Our study will examine secondary factors which encompass physical and psychosocial 
measures (Hypotheses 1B). 
 
Service Dogs and Healthcare Utilization: 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 show to have positive physiological consequences,43,44 leading to 
decreased health care utilization. Simply stroking a dog decreases physiological arousal, 
including lowering blood pressure, 43,44,45 decreasing heart rate and slowing respiration,46 and 
increasing finger temperature.47  Anderson et al.48 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 level, in addition to 
lower blood pressure levels. In general, a national probability sample from Australia found pet 
owners to have better health and decreased health care utilization as measured by number of 
doctor visits and medication use.48 Individuals who had companion animals visited the physician 
less often and used less medication according to other studies.49,50  If touching a dog can have 
such a remarkable impact, what are the long-term effects of human-animal interaction, 
specifically partnership with an SD?   
 
Very little data exists regarding health status and health care utilization of SD partners. A cross-
sectional study of SDs partners (n=57, response rate 90 percent) conducted by Lane et al.,5 found 
participants to report increased self-perceived health after receiving a SD, though most had 

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degenerative illnesses.  Fairman et al.’s cross-sectional survey reported SD partners used 2.1 less 
hours of paid and 5.9 less hours of unpaid assistance each week after receipt of their SDs. The 
estimated of cost savings due to decreased paid assistance hours was $600 per year. Based on the 
previously mentioned estimate of 16,000 SD 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.  
 
Individuals with PTSD are significantly correlated with increased health care utilization, work 
disability, lower socioeconomic status, morbidity, and mortality.51,52 Moreover, requiring 
assistance in activities of daily living (ADL) reliably predicts nursing home admissions, and as a 
result, has influenced state and federal healthcare policy. Limitations in ADL and instrumental 
activities of living IADL serve as eligibility criteria for public and private disability benefits as 
well as outcomes by which clinicians and researchers evaluate the efficacy of their 
interventions.43 The proposed study will examine healthcare utilization in relation to having 
a service dog (Hypotheses 2A and 2B). 
  
 
Significance of Research  
VA hospitals nationwide are integrating service dogs into treatment plans for disabled Veterans. 
However, with the training of SDs taking up to nine months and costs estimated at $23,000 per 
SD, the utilization of SDs as adjunct to mental health treatment is in need of investigation.  This 
study will be the first to assess the impact of highly trained SDs on the psychological, behavioral 
and social functioning of a Veteran population.   
 
The idea that the presence of animals can produce calming effects in humans is commonly cited 
in areas of stress reduction.53,54  Also, relevant to internalizing disorders are unconditional 
positive regard as well as acceptance, which may help to promote an increased sense of self-
efficacy and trust in others, as well as reduced feelings of rejection and inadequacy. Studies of 
the ability of animals to alter perceptions of social desirability and to increase positive social 
interactions between strangers have been uniformly positive.55 It has also been cited that pets 
provide feelings of companionship, security, and of being loved.56  It is thought that this occurs 
because animals provide an opportunity for emotional investment that is free of negative 
evaluation and not subject to feelings of rejection.57,58 Finally, companion animals may promote 
the formation of secure attachment relations with another living being and thereby contributing 
to one’s basic sense of trust.59  
 
To date, there have been no long-term follow-up studies of the impact or efficacy of animal-
assisted interventions. Although some have attempted to determine if changes in behavior could 
be observed beyond the context of the intervention (generally school and home) 60, 61  the results 
are conflicting.  
 
When considered alongside the large numbers of anecdotal statements attesting to the power of 
animals to hasten the building of rapport between patient and therapist, these findings have 
important healthcare implications. If the presence of an animal can make the therapist appear less 
threatening, it seems reasonable to believe that some patients would achieve a greater sense of 
comfort more quickly and remain in therapy.  In addition to enhancing the patient's perception of 

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the healthcare provider, the presence of an animal provides a benign, external topic of 
conversation on which to focus, which may further hasten and enhance the development of a 
working alliance. Given that compliance and retention in treatment, as well as treatment 
outcomes, may be strongly related to the quality of the therapeutic relationship, this particular 
aspect of animal-assisted interventions merits urgent investigation. 
 
The use of dogs as companions and an adjunct to current mental health treatment is quite 
promising.  Professionally trained SDs can assist Veterans find misplaced items due to cognitive 
memory loss (e.g., wallet, cell phone, keys); perform functions to assist with PTSD symptoms 
(e.g., alert bark, safety check of rooms, position self between stranger and owner in large 
crowds); result in fewer doctor contacts; and serve as catalysts or mediators of human social 
interactions and may expedite the rapport-building process between patient and therapist.62,63 Not 
only can a dog assist Veterans to meet physical challenges and proceed in therapy, but they can 
be utilized to overcome a lot of the mental instability that they feel. 
 
Preliminary Studies 
The principal investigator (PI) has completed several pilot studies on SDs. An overview of the 
studies is provided below.  NOTE: PI name changed in 2009 from Fitzgerald to Groer.  
 
Wheelchair Assistance Dog –Merit Review # D3078R was completed expanding the pilot work 
of the PI. For sake of space, information on the pilot studies has not been included. This 
prospective study compared four groups over an 18-month period: those who had recently 
received a SD and those waiting to receive a SD, those who had pets and those who did not have 
a pet. All participants completed questionnaires at baseline (prior to receipt of dog), and at 3, 9, 
12 and 18 months (post receipt of dog for the SD group). The questionnaires covered 
demographics, socioeconomics, health care utilization, and psychosocial characteristics (e.g., 
self-esteem, affect) as well as functional outcomes.   
 
There were a total of 186 participants enrolled in the Merit Review study.  Of these participants, 
123 completed all five collection points over the 18-months of the study and 14 were withdrawn 
or dropped out by missing more than one questionnaire.  The mean age was 46.1 + 12.2 years, 
having their disability/diagnosis for 25.3 + 15.6 years. Forty percent of the subjects had 
progressive disabilities ranging from multiple sclerosis to amyotrophic lateral sclerosis and 60% 
had non-progressive disorders such as cerebral palsy and spinal cord injury.  The population was 
also comprised of 83.9% Caucasian and 62.9% female. 31.4% were actively employed.  At 
baseline, groups were comparable in all outcomes. After all follow-up was completed, the only 
significant difference in psychosocial outcomes was found between groups with respect to 
depression (p=.047). No other measures were significantly different between the groups for other 
psychosocial variables [fatigue (p=.342), loneliness (p=.656), positive affect (p=.088), negative 
affect (p=.313) or self-esteem (p=.129)].  Significant differences were also seen the occupational 
component of the Craig Handicap Assessment and Reporting Technique CHART tool (=0.025). 
In both findings, those who were on the waiting list to receive the service dog were significantly 
more depressed and less functional (CHART) than the other groups. 64 
 
Epidemiology of Service Dogs was a second study funded by VISN 4 aimed to: 1) describe the 
population partnered with SDs based on the characteristics of the individual, 2) determine the 
association between of length of SD partnership and the individual characteristics and 3) 

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compare the characteristics described above between individuals who have yet to receive a SD 
and individuals already utilizing a SD. Identical information was collected as described for 
previous study.65 
 
Because of the large population that we recruited, we completed a secondary data analysis to 
examine sub populations.  Of specific interest, was to determine if those individuals who 
required human assistance would benefit more from a SD. Of the 375 individuals who 
contributed data, 89% were Caucasian, 66.4% were females with an average of 45.7 years old (+ 
12.9) and a mean duration of injury or disability equaling 23.4 years (+ 14.9). One hundred sixty-
four individuals (43.7%) owned SDs. 
 
Significant differences were found between the two groups (those who had SDs and those who 
did not) with respect to functioning and community participation as measured by the CHART. 
People who had SDs had more cognitive independence (p=0.00), were more able to participate in 
and maintain customary social relationships (p=0.00) and had better mobility than their 
counterparts. Those partnered with SDs had higher positive affect scores (p=0.000), but reported 
taking fewer medications than those individuals without SDs (p=0.000). Individuals with SDs 
reported using more hours of paid assistance for instrumental activities of daily living (IADLs) – 
such as running errands (p=0.000), than those without SDs. This suggests that if an individual 
requires functional help, SDs may be of benefit.66 
 
Hearing and Service Dogs: An alternative assistive technology: A service directed project 
(#B3089R) was subsequently funded to examine SDs and hearing dogs (HD) as an alternative to 
assistive technology (AT). A combination of questionnaires and observation was completed to 
assess types of assistive technology including healthcare utilization and caregiver help questions 
as well as specific questions related to SDs.  
 
Cost issues associated with AT: People partnered with a SD pay on average $75 per month to 
care for their dog while the SD comparison group also paid $75 per month for their AT needs.  
Although not statistically different, SD partners pay about $188 per month for their AT devices 
(p=0.16). However, these differences in costs associated with service dog versus AT devices is a 
function of disability and race (p=0.159).  In addition, participants partnered with a SD were 
asked if they had to make accommodations to their environment.  Eighty-eight percent made 
changes to their surroundings and 74% had to pay for these changes out of pocket with the 
median total cost being $400 and a range of $10 to $6,600.  HD partners paid about $100 per 
month to care for their dog in addition to an average of $74 per month for the AT needs.  In 
comparison, HD controls pay about $145 per month for their AT needs.  No significant 
differences were observed between these monthly costs (p=0.01).  When the HD individuals 
were partnered with their dog, 62% (n=8) made changes to their environment and 75% of these 
individuals paid for their accommodations.  The range of cost for changes was $75 to $2000 with 
a median cost of $250.   
 
Assistance dogs specific questions: For those individuals partnered with assistance dogs, 
additional questions were asked that were specific to the reliability and satisfaction of their dogs.  
For those with SDs, 90% reported being very satisfied with their dogs overall. Similarly, 82% 
were very satisfied with the agency from which they obtained their dogs, and 86% were very 

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satisfied with the training the agency provided for using their dogs. Eighty-five percent of the SD 
partners received follow-up training with their dogs and of these individuals, 81% were 
extremely satisfied with this training. Overall, about 86% of the population felt their SD was 
very reliable.   
 
For those who were partnered with HD, 69% stated they were very satisfied with their dog,  77% 
stated they were very satisfied with the dog agency as well as the training they provided to work 
with the dog.  Seventy-nine percent of the population partnered with HDs received follow-up 
training of their dogs, with 67% being very satisfied with this training.  Eighty-five percent of the 
HD respondents rated the reliability of their HD greater than an eight on a scale of 1-10, with 10 
being most satisfied (> 9). 
 
Very little data exists regarding changes in health care utilization of individuals partnered with 
assistance dogs. This study found that those with dogs were less likely to have visits to the doctor 
and spend less time than their counterparts. Although number of visits is a crude measure of 
healthcare utilization it still represents a potential that the impact assistance dogs may have on 
their partner. Research conducted on pets in general has shown that contact with them may 
actually decrease the occurrence of disease as well as decrease stress and anxiety. Within this 
respect, the dog is not only benefiting the individual from a technology perspective but also a 
psychosocial perspective. 67, 68,69, 70 
 
Research Design and Methods 
Design 
 
This 3-year, mixed methods modified, non-randomized trial will follow individuals for two 
years.  Due to the inability to recruit veterans interested in participating in a control (no dog) 
group, this group has been eliminated going forward with the study.  The study will examine the 
influence of SDs by assessing the longitudinal change in mental health assessment over time 
among veterans who have PTSD. The group will consist of individuals partnered with SDs. 
Following initial screening for inclusion criteria, including criteria set by dog vendors, subjects 
who are eligible will receive a SD. This study will measure changes over time in the primary 
outcome of mental health. Additional outcomes in psychosocial health and healthcare utilization 
will be included. Recruits successfully completing the  screening process will be placed on a 
vendor’s waiting list to receive a SD upon the dog’s completion of training. Recruits  who do not 
meet all criteria, including vendor criteria, will be ineligible to participate.. 
 
Data will be collected at baseline and at 3, 6, 9, 12, 18 and 24 months for individuals with 
service dogs. For those awaiting service dogs, repeated assessments will occur every 3 months 
until obtaining a SD. Once baseline data has been collected for 24 months, assessments will 
occur every 6 months until the Veteran is paired with a SD.  Baseline data will include detailed 
information on the characteristics of the participants, their mental health, psychosocial well-
being, socioeconomic and healthcare utilization characteristics. As we want to obtain 
information regarding the changes in health and wellbeing over time, a prospective study will 
permit this type of comparison.  
 

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Sample: The study will use a convenience sample of VHA patients who are currently in 
treatment for PTSD. We have chosen to use these criteria as a safety measure for the veteran and 
the dogs. At this time, there are currently 600 veterans receiving care at James A. Haley VAMC 
for PTSD, with an estimated 25 new veterans seen in the clinic per week. We are confident that 
an adequate number of Veterans will be recruited for the study. We will monitor recruitment and 
retention numbers on a monthly basis. The use of additional VA hospitals as a potential source 
for recruitment is the contingency plan should we be unable to meet enrollment numbers.  
We will be enrolling up to 220 Veterans to be paired with service dogs  The previously cited 
longitudinal study had only an eight percent attrition rate.  Although similar methods are 
included in this proposal, we recognize that this is a different population; we will plan on a 
higher attrition rate. Thus, we are estimating a 15 percent drop-out rate (n=33), and we will over-
recruit participants. Up to two hundred and twenty participants will be recruited over the course 
of the study. These recruitment numbers are chosen with the expectation that 200 individuals 
will complete the study.   
 
A repeated measures design with one fixed effects (any one covariate [TBD]) and 1 within 
subject effect (time; each subject is measured 5 times [minimum]) achieves approximately 100% 
power to test the primary fixed effect (dog group status) if a Geisser-Greenhouse Corrected F 
Test is used with an alpha level=5% and the actual effect SD=0.47 (effect size=5.54). Further, 
this design achieves approximately 100% power to detect a significant effects among both 
covariates (alpha level=5%, SD=0.8; effect size=5.54) and significant interaction between both 
the primary fixed effect (dog group status) and each of the covariates (alpha level=5%, SD=0.8; 
effect size=5.54). This analysis assumes a 1st order auto correlation between repeated 
assessments equal to 0.80. 
 
To assure that we recruit sufficient sample size, we will initiate the following strategies: (1) 
carefully consider respondent burden when finalizing the baseline survey and interview schedule, 
(2) employ and train research assistants/data collectors with previous experience in collecting 
data and who have good communication skills, (3) provide a small reimbursement ($10.00) for 
participant time and effort each time a questionnaire is returned, (4) develop posters and 
recruitment flyers which will be displayed in all mental health clinical areas, and (5) provide in-
services on a regular basis to the PTSD and other mental health clinicians explaining the study. 
These methods have been used successfully in the past by the research team. 
 
The investigators will track all subjects who contact them for potential participation in the study. 
Reasons for individuals deciding not to participate will be tracked. In the past, reasons that have 
been recorded include time, and effort to make appointments.  The eligibility criteria will also be 
tracked so that a description of the population and who met criteria to enter the study (or not) can 
be described for future publications. These methods are used in all studies that the PI conducts.  
 
To assure that we retain sufficient sample size, we will initiate the following strategies: (1) coach 
the research assistants in establishing rapport during all contact (in person and telephone), (2) 
reminders sent in advance of in-person interviews and packet of information sent to participant 
two weeks prior to the time of their scheduled interview, alerting the participant that we will be 
calling, (3) at the end of all visits, provide the participants the phone number with which to 
contact researchers should they have to change their next visit, as well as provide the name and 

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Dogs and PTSD: V11: 11.26.14 
 
 
phone number of the supervisor should they have problems (4) send out a thank you card once a 
year to let participants know their efforts are appreciated, (5) keep the interviews to a minimum 
to lessen respondent burden, and (6) conduct quality assurance for the visits to assure that 
participants are being interviewed appropriately. These methods have been used successfully in 
previous studies conducted by the PI.  
 
Inclusion/Exclusion Criteria  
 
Inclusion Criteria 
Description  
Age 
Age greater than or equal to 18 years 
Referral 
Referral from VA provider which documents PTSD diagnosis.  
PTSD  
 
PTSD symptoms as documented in the clinician referral letter. 
Treatment 
for 
PTSD 
In active treatment for PTSD for at least three months at time of 
enrollment and remain in treatment throughout the duration of the study. 
Participation will be verified quarterly to ensure that the veteran is still 
in treatment. 
Acceptance by the 
dog vendor 
Will be a function of the vendors that agree to provide dogs.  
Dog care 
Ability to adequately care for a dog, physically/financially.  Has suitable 
home environment to provide for a dog.  Has someone to care for a dog 
in the absence of the Veteran.  
Travel to vendor 
Willing and able to travel to vendor location by air or car for pairing 
Geographic 
location 
Living the state of Florida 
 
 
 
 
 
 
 
 
Exclusion Criteria 
Description  
Mental 
Health 
Hospitalization 
Veterans will be excluded if they have been hospitalized for mental 
health reasons in the prior 6 months.  
Residence 
Not living at the same residence for 6 months. It will be emphasized to 
the subjects to try and maintain the same residency throughout the 
duration of the study. Rationale is to ensure access they have appropriate 
follow up available to them both clinically and for the service dog. 
Specific 
Diagnoses/conditi
ons 
Psychoses, Delusions, dementia, active alcohol/substance abuse or 
dependence, moderate to severe TBI as documented by chart review, 
suicide flag in CPRS.  Study staff identifies a social, mental, or physical 
condition that prevents the Veteran from giving informed consent or 
participating in the study   

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Dogs and PTSD: V11: 11.26.14 
 
 
Active 
suicide 
/homicide 
At time of entry – Active suicide/homicide plan or intent, cognitive 
disabilities that would preclude safety of animal and ability needed for 
participation in the study  
Children under 10 
Veterans with children under 10 years of age in the home for more than 
8 hours per day one day a week or more will be unable to participate. 
Dual 
Enrollment  
without approval 
While in this research study participants are required to check with the 
study team prior to enrolling in a secondary study.  Taking part in other 
research studies may invalidate the results of this research, as well as 
that of the other research. As a result, participation in this study may be 
terminated. 
 
 
 
 
Participant Recruitment and Informed Consent 
A HIPAA waiver will be obtained for the project manager to review CPRS to identify Veterans 
who are under treatment for PTSD. A list will be generated of Veterans and letters will be mailed 
to inquire about the Veteran’s willingness to participate in the research study. Veterans will be 
directed to respond to the project manager of the study either via return mail or calling the 1-888 
number available for the Center of Excellence. The project manager and/or data collectors will 
coordinate the timing of the screening visit. Flyers (which are already approved) will be provided 
to clinicians and other professionals that work for the VA and dog vendors that are providing 
dogs so that they may be distributed to Veterans. The flyer will also be printed as posters, to 
enable hanging in relevant areas of the hospital. If needed, veteran organizations (e.g. Paralyzed 
Veterans of America (PVA)) will be asked to print/distribute flyer in their newsletters. Other 
methods of recruitment will include posting announcements on relevant websites (e.g. PVA) to 
advertise the research study.  
 
Opposed to matching, we will use a modified statistical method, minimization,71 that facilitates 
equalizing study groups to assure similarity of disease characteristics, gender, and age. Similar to 
stratified sampling, our modified minimization technique involves examining groups to 
determine distribution of participants in selected confounding variables such as progressive and 
non-progressive disabilities. When an imbalance in such a variable occurs, recruitment will be 
aimed at the group with the lesser number of participants. This method will help minimize 
possible confounding variables, thus improving the validity of conclusions drawn. 
 
Screening Visit: Once a Veteran has agreed to participate in the study, they will be asked to 
participate in a screening visit. Once the informed consent process is finalized, eligibility criteria 
will be confirmed. A review of CPRS records will be conducted by the study team to verify the 
Veteran truly meets all criteria.  At this time, if all criteria are met, all baseline questionnaires 
will be completed and field notes taken. For safety reasons, Veterans who have children younger 
than 10 years of age in the home for more than 8 hours per day, one day per week or more will 
be excluded from the study.  After 20 dogs have been placed without incident, this criterion will 
be revisited to potentially allow these Veterans to participate. 
 
• The study team will perform a home evaluation visit prior to referring Veterans to 
a vendor.  This visit will be to ensure the environment is safe and suitable for a 

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Dogs and PTSD: V11: 11.26.14 
 
 
dog.  A home environment checklist has been developed and will guide the study 
team in assessing the environment.  An information sheet that provides details to 
Veterans regarding why and how the home visit will be conducted will provided 
to Veterans when Informed Consent is obtained. During the visit, the team will 
check to see that there is an area for a dog to exercise, relieve itself, sleep, as well 
as making sure hazardous plants or chemicals are not within reach of a dog.  All 
family members that will be living in the home will be expected to meet with the 
study team to ensure they understand the study requirements and are on board 
with bringing a dog into the home.  If any issues are identified by the study team 
during the home evaluation the Veteran will have 3 weeks to fix the issues and 
reschedule a follow up home evaluation visit.  If during the follow up home 
evaluation the study team determines that the issues are not fully resolved the 
Veteran will have one additional week to remedy the issues and reschedule a final 
home evaluation.  If the issues remain unresolved the Veteran will be withdrawn 
from the study.  Once the home evaluation has been approved the Veteran will be 
provided with contact information for the vendor.  The Veteran will be instructed 
to contact the vendor and will be placed on the waiting list.  The Veteran will be 
encouraged to review home owner/rental insurance policy to include a dog and be 
required to obtain a license for their service dog per local laws. 
 
 
At this time, three vendors have been awarded contracts to provide dogs for this study. The RFI 
which was posted by the Contracting Office for the provision of service dogs for this project 
states “The National Defense Authorization Act for Fiscal Year 2010 specifically states, under 
Sec. 1077., Department of Veterans Affairs Use of Service Dogs for the Treatment or 
Rehabilitation of Veterans with Physical or Mental Injuries or Disabilities, para (b)(1)(B): The 
Secretary shall carry out the study by partnering with nonprofit 501(c)(3) organizations that are 
accredited by, or adhere to standards comparable to those of, an accrediting organization with 
demonstrated experience, national scope, and recognized leadership and expertise in the training 
of service dogs and education in the use of service dogs.”   
Due to the concern that vendors could influence Veterans and thereby introduce bias, the 
interaction between vendors and Veterans will be limited.  The study team will screen the 
enrolled Veterans to ensure vendor criteria are met.  The vendors will require an interview to 
provide insight into the applicant’s personality and lifestyle, allowing them to match the 
Veteran’s personality and temperament with that of the dog they will receive.  This interview 
may take place over the phone or in person, depending on the location of the vendor.  Study team 
personnel may be present during this interview.  The Statement of Work (SOW) provided to 
contracted vendors specifies that vendors are to limit their contact with Veterans to only what is 
necessary for assessment and training/pairing. 
Once vendor screening and application is completed, vendors will provide input, based on their 
expertise as to who will qualify for a SD. The process for accepting the participant to receive a 
service dog will be a function of the vendor’s current practices. As previously stated, the study 
team will have the vendor’s acceptance criteria ahead of time to minimize the chance that a 

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Dogs and PTSD: V11: 11.26.14 
 
 
Veteran will arrive to the training location and be turned away.  This will help to avoid distress 
on the part of the participant by thinking they are getting a dog and then being declined.   
Training of SDs for a specific individual takes time, and immediate placement of a dog with a 
Veteran most likely will not occur. Thus, baseline data collection will occur at the time of 
consent and every three months until the dog becomes available for the Veteran. If a Veteran 
completes 24 months of observation and is still not paired with a dog, assessments will continue 
every 6 months until a dog becomes available.  If the Veteran is not been paired by 48 months 
they will be withdrawn from the study.  Through observations and questionnaires we will ask the 
Veteran about how they feel, their mood, and their quality of life.   During the waiting period, 
Veterans will be required to take an education course related to dog care and responsibility of 
dog ownership.  This course will be provided by the study team and will be online through CITI 
or via paper copy.  A paper copy of the Education Modules in the course will be provided to 
Veterans as a reference.  Course content will cover all aspects of Service Dog ownership 
including grooming, health maintenance, and financial responsibility.  A competency test will be 
given at the end of the course to ensure Veterans understand the material.  If the Veteran fails to 
pass the test with a score of 80% or better, remedial training will be given by the study team and 
the test will be re-taken until passed.  A Veteran Guide for Veterinary Care information sheet 
will be provided at this time as well.  This Guide will contain information about health 
maintenance and when to take the dog to the veterinarian.  
Once the study team receives word from a vendor that a SD is about ready for pairing, the 
Veteran and vendor will have an opportunity to talk to ensure that an appropriate match will be 
made.  When the dog is ready, the Veteran will be required to travel to the vendor location.  
Travel may be by air or car, depending on the vendor location and considering the Veteran’s 
preference when possible.  If a Veteran drives their personal vehicle, he/she will be reimbursed 
at the government mileage rate upon completion of training and return home. Vendor staff will 
make travel and lodging arrangements for the Veteran.  Lodging, air travel, and meals will be 
paid for by the vendor during the pairing (per Federal regulations) and reimbursed by VA per the 
SOW.  The pairing process may vary by vendor and can last from one to three weeks.   
Follow up visits after pairing: One week after bringing the dog home, the Veteran will be visited 
by the study team to ensure the transition into the home is going well and to ensure the safety of 
the Veteran and the dog.  A SD Post Pairing Evaluation form will be completed.  The Post 
Pairing Evaluation is an objective evaluation of the dog’s health and behavior while the SD 
Questions speak to the Veteran’s subjective feedback regarding the dog’s behavior and their 
satisfaction with the dog.  If concerns are identified, they will be addressed through additional 
home visits and training sessions with the VA trainer.  After the initial questionnaire is 
completed, participants will be visited by the study team Dog Trainer or VA veterinarian months 
one and two to query the veteran about their dog’s behavior. These interactions will be 
completed in person and a SD Post Pairing Evaluation form will be completed at each visit. If 
problems are noted, the PI will be notified and additional training will be provided by the dog 
trainer on the team.  At months 3, 6, 9, 12, and18,  many of the same baseline questionnaires will 
be completed. For month 24, the same questionnaires completed at baseline will be administered. 
These questionnaires will be mailed to the Veteran or completed over the telephone. In addition, 
after receipt of the service dog, follow up home visits will occur at months 3, 6, 9, 12, 18, and 

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Dogs and PTSD: V11: 11.26.14 
 
 
24. These follow up visits will be done in person and will encompass the data collector of the 
study and the VA dog trainer or veterinarian meeting with the Veteran and 1) collecting 
questionnaires if necessary, 2) watching interaction between Veteran and SD and completing the 
SD Post Pairing Evaluation and SD Questions, 3) completing an  assessment of lethality which is 
standard operating procedure for clinicians to complete that no suicidal ideation or intent 
currently exists, 4) taking field notes, and 5) answering any questions should they arise.  
Correspondence between the Veteran participants and research team will be noted in a secure 
electronic database.   If the assessment of lethality indicates problems, the Veteran’s clinician 
will be called immediately.  Veterans may be asked to meet with the Dog Trainer or veterinarian 
in a public setting (restaurant, park, etc.) so the Trainer or veterinarian can observe the dog’s 
behavior in an unfamiliar setting.  Periodic visits may be made to the Veteran by the funding 
agency to ensure safety and satisfaction of the SD. Questionnaires may be completed in person, 
mailed to the Veteran, or completed over the telephone. 
   
The Veterans will be required to take their SD to their veterinarian for a wellness check every 6 
months.  The visits will start six months after receiving a service dog.  Once per year, dogs will 
receive a comprehensive exam by their veterinarian.  A Veterinarian Checklist will be provided 
to ensure a thorough exam is performed as required in the SOW.  Veterans will provide the 
Checklist to their veterinarian during the visit, and the veterinarian will fax the completed form 
to the COTR.  The fax will not contain any Veteran PHI and will be identified by the dog’s 
name.  Dogs will be taken to the veterinarian for health maintenance or for illness or injury as 
needed and Veterans will be asked to notify the study team any time the dog is taken to the 
veterinarian.  VA will provide health insurance for the dog through a contract with Trupanion.  
Veterans will be provided with an ID card that allows them to use the veterinarian of their 
choice.  All medical needs will be covered by this policy and the Veteran will have no out of 
pocket costs for healthcare related to the dog.   
 
A Data Safety Monitoring Board (DSMB) is in place and will review reports provided by the 
study team to ensure ongoing safety of the veterans and SDs.  The Board will advise and provide 
input and corrective measures as needed. 
  .  
Completion of the questionnaire takes approximately one hour, and the questionnaires will be 
completed a total of six (6) times over the Veteran’s 2 year participation in the study. All 
participants will be paid $10.00 for their time and effort to participate in each of the data 
collection sessions. This includes the six visits that will occur after the baseline visit (total of 
$70.00) as well as the data collection visits which will be conducted prior to delivery of the 
service dog. It is unknown how long it will take to have a SD placed with the veteran. Those who 
have been paired with a SD will receive $75.00 per month for dog upkeep for the duration of 
their participation in the research study. This was written into the ‘Bill’, (and previously, we had 
not included it in the protocol). Veterans will be informed that payment may be received by mail 
or direct deposit into their bank account. In addition, veterans will be informed that payment may 
take up to 8 weeks to be received after completion of questionnaires and for the first $75.00 
payment. The study team will do everything possible to ensure timely payment. The funding 
agency may choose to visit Veterans to ensure their continued success in the study and dog 
pairing. In this case, Veterans will be paid $10.00 for their time and effort.  
 

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We have chosen to follow individuals at these intervals, as we are building upon an earlier dog 
study framework. Although every effort will be made to contact participants at the scheduled 
times, there will be a 2-week window allowed from the target date to contact the participant. 
Should no contact be made, a second attempt to contact will take place 2-weeks beyond that to 
ensure that the participant still would like to participate. Although we originally planned to drop 
participants from the study should they fail to complete the questionnaire, this would entail the 
person having to give up their dog (if they were paired). We feel that with the in person visits 
with the individuals with service dogs as well as the less burdensome questionnaire, participants 
will be more likely to complete the surveys. To remove the dog from the veteran due to failure to 
complete questionnaire was deemed inappropriate.   
 
Intervention: The vendor(s) will provide SDs for the Veterans enrolled in the study. The dogs 
will be trained according to their standards and will meet the criteria outlined in the Statement of 
Work (SOW). All dogs will be trained in basic obedience and a standard set of commands 
related to mitigation of PTSD symptoms.  Due to previous vendor issues, the updated SOW calls 
for vendors to use only purpose bred dogs (no rescues) which have passed a thorough medical 
work up and have been “proofed” by a VA dog trainer with extensive experience in training 
dogs.  Veterans will be expected to follow all directions from the vendor(s). Should a Veteran 
need hospitalization for mental health reasons at any time after they are enrolled, they will not be 
dropped from the study.  Veterans must remain in active treatment for PTSD for the duration of 
the study.  Any Veteran who stops receiving treatment for their PTSD symptoms will be dropped 
from the study and the service dog removed and returned to the vendor. To ensure Veterans are 
still in treatment, quarterly verification of mental health treatment will be done by contacting the 
Veteran’s clinician directly or reviewing the medical record..  
 
Once a Veteran has completed their participation in the study, they may choose to keep their dog 
or return it to the vendor.  If the Veteran chooses to keep their dog at the end of their study 
participation, they take full responsibility for the care of the dog.  Neither the study nor the VA 
provides further support to the Veteran to care for the dog upon completion of the two year 
period.  If keeping their dog, Veterans may be required to return the dog’s service vest to the 
vendor who provided it. Once out of the study, the Veteran will be able to contact the vendor 
directly and receive any follow up services provided by the vendor.  Such services may include 
training support, supplies, support groups, or other services. 
 
 
Dog removal:  There may be instances when a dog would be removed from a Veteran’s care 
after pairing.  Quarterly home visits will be done to evaluate the status of the pairing and to 
ensure the safety and wellbeing of the dog and the Veteran.  If there is evidence of mistreatment 
of the dog, it will be removed from the Veteran and returned to the vendor per the SOW.  This 
evidence includes signs that a dog has been hit or kicked (cowering, shaking in the presence of 
the Veteran or a family member, head shyness), very low weight in the absence of a medical 
condition, skin sores in the absence of a medical condition, the dog stays away from the Veteran 
or a family member, evidence that the dog has been tied to an object outside (neglect), gross 
parasite infection (fleas, ticks), and any other circumstance that would show neglect or abuse. 
 

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Sometimes, pairings fail because a bond cannot be established between a dog and a person.  
Vendors are experts at matching human and animal personalities to limit the possibility that this 
would happen.  Based on information from vendors, a failure will usually occur within the first 
two weeks after returning home with a dog.  In the case of a failed pairing within the first two 
weeks, the VA dog trainer will intervene and inform a Contracting Officer Representative 
(COR), who will inform the vendor.  Per the SOW the dog will be returned to the vendor and a 
replacement dog sought.  The Veteran may be required to attend another training session at the 
vendor location.  If a pairing fails due to lack of bonding more than two weeks after returning 
home, it will be assessed by the VA dog trainer and dealt with on a case by case basis. 
 
If a Veteran chooses to withdraw from the study after receiving a dog, the dog will be returned to 
the vendor.  If a Veteran is not being treated by a mental health provider after receiving a dog, 
they will be withdrawn and the dog will be returned to the vendor. 
 
If a Veteran moves out of the state of Florida after being paired with a dog, the study team will 
meet with the Contracting Officer Representative, the Data Safety Monitoring Board, and the 
study sponsor to determine whether the Veteran can remain in the study or should be withdrawn.  
These situations will be handled on a case by case basis. 
 
At the end of the two year data collection period the Veteran may decide not to keep his/her dog.  
If a Veteran chooses not to keep their dog, it will be returned to the vendor. 
 
Dog replacement:  Per the SOW, if a dog develops disqualifying health or behavioral problems 
at any time after pairing the dog can be returned to the vendor.  The VA dog trainer and COR, 
who is a veterinarian, would evaluate whether the problems can be easily remedied or if the dog 
should be returned to the vendor.  If another dog can be provided quickly enough a replacement 
dog will be provided to the Veteran.  If a dog dies due to circumstances outside of the Veteran’s 
control, such as a terminal illness, a replacement dog may be provided.  The Veteran may be 
required to attend a second training session at the vendor location.  These situations will be 
handled on a case by case basis to determine whether a replacement dog will be provided. 
 
Measurements: Outcomes and Independent Predictors 
The outcomes to be measured by this study will be grouped into four categories: mental health, 
physical, psychosocial and socioeconomic/healthcare utilization. Table 2 shows an outline of the 
study outcomes, predictor variables, and possible confounders to be obtained from all 
participants.  
 
 
Table 2: Measurements 
 
Constructs 
Measures 
Burden 
Mental Outcomes 
 
 
 
PCL -S 
PTSD diagnosis/symptom 
severity 
5 minutes  
Depression  
PHQ-9 
5 minutes 
Alcohol use 
AUDIT-C 
5 minutes 
Time point: baseline, 
final 
Physical Factors 
Co-morbidities 
Medical record,  
None to subject** 

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Constructs 
Measures 
Burden 
Medication  
 
Type, class, dose  
 
None to subject ** 
Sleep 
Pittsburgh Sleep Index and 
PSQI Amendment for 
PTSD 
 10 minutes 
Psychosocial 
Factors 
Health-related 
Quality of Life  
SF12 
10 minutes 
Community 
participation 
 Community Integration 
Questionnaire 
10 minutes 
 
Demographic 
Age, gender, race/ 
ethnicity, marital status 
5 minutes  
Service Dog 
Satisfaction  
Tasks 
Behavior, Level of 
satisfaction with the 
performance of service 
dog and what tasks are 
completed 
10 minutes 
Follow up visits 1, 2 , 
3 and thereafter; only 
after pairing 
Economics 
Socioeconomic 
factors 
Employment , hours 
worked, years of 
education, health 
insurance, income 
5 minutes 
 
Healthcare 
utilization 
Number of visits to 
healthcare in previous 3 
month time period, for 
both mental health and 
general health care visits 
 
 
Healthcare costs 
Out of pocket expenses, 
self-report of outside 
healthcare 
10 minutes 
 
Other Forms 
Form 
Purpose 
When Completed 
Who Completes 
Home 
environment 
checklist 
Checklist to assess home 
environment prior to dog 
placement 
Pre-pairing home 
visit 
Study Team Dog 
Trainer 
Dog Care Test 
Test knowledge of dog 
care and responsibility 
After completion of 
Dog Care Course 
Veteran 
Service Dog 
Post Pairing 
Evaluation 
Assess pairing and 
identify potential health or 
behavior problems in dogs 
One week post 
pairing, months 1, 2, 
3, 6, 9, 12, 18, 24 
Study Team Dog 
Trainer at home visit 
Veterinarian 
Checklist 
Assess dog’s health 
Once per year 
Veterinarian caring 
for each dog 
Veteran Guide 
for Veterinary 
Care 
Provides information to 
Veteran about maintain 
dog’s health 
Provided when Dog 
Care Course is 
completed 
Information provided 
to Veterans 
Home visit 
information 
sheet 
Provides information to 
Veterans about how and 
why the home visit is done 
Provided after IC, 
prior to home visit 
Information provided 
to Veterans 

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Dogs and PTSD: V11: 11.26.14 
 
 
Service Dog 
Questions 
Veteran’s subjective 
report about the dog’s 
behavior and Veteran’s 
satisfaction with the dog 
Months 3, 6, 9, 12, 
18, 24 
Study team member 
present at home visit 
 
Unless otherwise noted, all measures are completed at all visits. 
**Data for these items will be abstracted from medical record  
 
Mental Outcomes: Outcomes for the main hypotheses will be measured with the following 
measure using the PTSD Checklist (PCL). 72. PTSD Checklist is a 17-item self-report measure of 
the 17 DSM-IV symptoms of PTSD. Respondents rate how much they were “bothered by that 
problem in the past month”. Items are rated on a 5-point scale ranging from 1 (“not at all”) to 5 
(“extremely”). The PCL can be scored in several different ways. A total score (range 17-85) can 
be obtained by summing the scores from each of the 17 items. Although the CAPS was used 
initially for the study, it was decided by the research team with input from the funding agency 
that diagnosis of PTSD will be confirmed by referring clinician and eliminate stress of 
completing the interview for the veteran. For some of the veterans that are enrolled in the study, 
CAPS is available in their medical record. If it is available, we will abstract the information to 
further confirm the diagnosis.  
 
Alcohol Use Disorder Identification Test (AUDIT-C) and/or Addiction Severity Index –Alcohol 
Use Disorders Identification Test (AUDIT)-C is a 3-item paper and pencil alcohol screen to 
identify hazardous drinking or those with problematic alcohol consumption use (abuse and 
dependence). There is a five-point scale ranging from 0 to 4.  The items are summed to obtain a 
total score ranging from 0-12. For men, a score of 4 or more is considered positive.  For women, 
a score of 3 or more is considered positive. Internal consistency reliability has been reported as 
0.80.73, 74 
 
Physical factors: Physical factors will include items that can be drawn from the medical record 
(co-morbidities, medications). Abstracting medical record data at least one year prior allows for 
an evaluation of trends or sudden departures from normal care or medication profiles. In 
addition, we will track the number of visits and type of therapies that the subjects will be 
participating in while in treatment for their PTSD.  
Pittsburgh Sleep Quality Index (PSQI) is a 24 item self-administered survey used to assess sleep-
related problems during the past month. The first 19 items are completed by the subject and there 
are five items 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 quality75. The seven component 
scores of the PSQI had an overall reliability coefficient (Cronbach’s α) of 0.83.  We will also be 
using the PSQI-A, addendum for PTSD.  The PSQI-A asks an additional ten questions that target 
PTSD-related sleep problems. 

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Psychosocial factors:  
Community Integration Questionnaire (CIQ) consists of 15 questions focusing on community 
integration behaviors. The CIQ is used to assess integration behaviors in the home, in social 
settings, and in productive activities such as employment and education. Items are scored on a 0-
2 scale and scores can range from 0-29. A high score indicates greater independence and better 
community integration. The CIQ has been reported to have excellent internal consistency 
(Chronbach’s α = 0.76)76 and test-retest reliability (0.96)77. 
Health Related Quality of Life will be assessed by the SF12. This is a subset of the SF-36, a 
generic health status measure that has been shown to be valid and reliable in a wide variety of 
health care settings.78,79  
 
Socioeconomic Factors: Factors of socioeconomic status will include items related to 
demographics (e.g. age, gender, marital status) and economic items which will include years of 
education, type of employment and occupation, income (self and household), type of health 
insurance carried, and number of individuals living in household.  
 
Healthcare utilization: will encompass out of pocket expenses, and asks number of visits to health 
professionals over the past year (an average per month will be determined), average annual out-
of-pocket healthcare expenses, current prescription medication used, etc.  
 
 
Data Management and Statistical Analysis 
Data Management: All data will be entered into a database developed for this project. Prior to 
data entry, all data will be reviewed for inconsistencies and missing values. All variables will 
have limitations imposed (range checks for high and low limits for the variable values). The 
database is password protected for confidentiality and data entry personnel will have read only 
access, so that data can be entered, but fields cannot be manipulated without investigator 
permission. A data safety and monitoring plan will be implemented to ensure no changes in the 
benefit/risk ratio occur during the study, and that confidentiality of research data is maintained. 
Investigators, study personnel, and the clinical coordinators involved in the study will meet 
monthly to discuss the study (e.g., study goals, progress, modifications, documentation) and 
address any issues or concerns at these meetings. Any instances of adverse effects will be 
reported immediately using the standard forms and/or procedures set forth by the Institutional 
Review Board. In addition, clinical coordinators from the Institutional Animal Care and Use 
Committee (IACUC) will periodically review study documentation and/or consent forms to ensure 
the safety and well-being of the dog participants.   
 
Federal laws state that we must keep study records private.  We will keep the records of this 
study private and confidential by locking them in a cabinet within a locked office in a secure 
building. Data will be maintained on a secure computer with encryption. Consent forms and 
notes will be transported back to the James A. Haley VA via locked security bag.  All data 
collected will be maintained and stored according to VA regulations.  

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Dogs and PTSD: V11: 11.26.14 
 
 
All computer data will be encrypted to protect patient confidentiality. VA and other Federal 
privacy, confidentiality and HIPAA regulations will be strictly adhered to.  Data will be secured 
on a VA server behind VA firewalls, and access will be password protected and restricted to a 
limited number of study personnel.  Fax machine available will be secured. All information 
collected by agencies shall be kept securely by the agency.  
 
Analysis: The distribution of each variable will be examined for outliers to determine if 
transformations (to normalize data) are necessary. Initially, means ± SD, and medians, will be 
calculated for all continuous measures (e.g., age, psychological scales). Frequencies and percent 
will be determined for categorical variables (e.g., gender, race, etc.). Variables considered 
‘confounders’ (demographic and dog predisposition questionnaires) would be compared across 
time for the relevant hypotheses. Categorical variables (e.g., gender, race, disability) will be 
compared across groups using chi-square. Continuous variables (years of disability, dog 
predisposition scores) will be compared using ANOVA. Baseline differences will be noted and 
controlled for in additional analyses. A significance level of ( < 0.05) will be used for all 
analyses. All data will be managed as intent to treat.  
 
Statistical Analyses are presented below by hypothesis:  
Hypothesis 1A: Individuals partnered with SDs will have greater improved mental health over 
time. Baseline data will be examined. Observed significant differences will be used as covariates 
in modeling, they will be controlled in subsequent analysis. For this hypothesis, a linear repeated 
measures mixed model will be used to determine changes over time between groups. PCL-
checklist scores will be considered the dependent variable. Baseline PCL-C scores will be 
introduced in all models as covariates. These scores are continuous. The use of mixed models 
allows for control of covariance data expected in clustered and repeatedly sampled data, and 
missing data. We expect the SD group to have greater functional independence and community 
participation at the end of the study. 
 
Hypothesis 1B: Improvements in secondary factors of physical, psychosocial, and 
socioeconomic variables will be seen in the SD group over time.  Variables within the physical 
(medication, comorbities), psychosocial (affect, depression, loneliness) and socioeconomics 
(healthcare utilization) will be compared over time and will be assessed for each variable of 
interest using a repeated measures mixed model for dependent variable (DV) scored a continuous 
scale and generalized estimating equations (GEE) models for DV variables scored as a 
categorical. Dependent variables for all models will be scale or subscale scores. The within-
participants variable will be the score at each time point (baseline, 3, 9, 12, 18 and 24 months). If 
significant differences exist at baseline for any confounding variables, that factor will be 
controlled for in the analysis. We expect to show improvements in all characteristics over the 
course of the study.  
 
We will also complete a multivariate logistic regression to determine predictors of success 
(dichotomized higher scores after 18 months on function and participation). We expect that 
improvements in psychosocial factors (e.g, community participation) will result. We expect the 
data to be normally distributed; therefore, linear regression will be used. Results from the 
previous hypotheses (1B) will be used to determine which predictor variables are entered into the 
regression model; any variable with a p-value less than 0.10 will be considered. Highly related 
variables will be entered into the model separately. Any confounders significant at baseline will 

23 
 
Dogs and PTSD: V11: 11.26.14 
 
 
be controlled for in the models. In addition, we will repeat the multivariate logistic regression 
analysis described above with group (SD vs. control) as a primary fixed variable. We expect that 
subjects paired with a SD will demonstrate increased improvement in psychosocial factors.  
 
We expect some individuals to benefit more than others. We hypothesize that individuals with 
greater limitations will have the most improvement when provided with an SD. Consequently, 
we will conduct a sub-analysis of the SD group. We acknowledge this is an exploratory analysis 
and the power is limited. The hypothesis we will test is individuals who score lower in 
psychosocial factors (e.g. community participation) at baseline will show greater improvements 
in those characteristic than individuals who scored higher. Therefore we will use the 
subcomponents scores of continuous measures and dichotomize them at a clinically meaningful 
point (e.g., > 80 > 75th percentile) at the baseline measure. All individuals will be put into one of 
two groups based on this cutpoint. Repeated measures analyses will be completed on all 
continuous variables with the between factor being the two groups and the within measure 
equaling variables of physical, psychosocial and economic characteristics.  
 
In addition, we will conduct an exploratory analysis to determine whether relationships exist 
between group status (SD vs. control), demographic variables (age, gender, living arrangements, 
marital status, etc.) and the outcomes of interest – mental health (, PCL-C) and psychosocial 
factors (e.g. community participation). Categorical demographic variables will be analyzed using 
a chi-square for variables that are dichotomous, and one-way ANOVAs will be used for 
continuous variables that have multiple categories. Continuous demographic variables (e.g., age) 
will be compared to the outcomes using correlations: Pearson for normally distributed variables 
and Spearman rho for not-normally distributed variables. Sub-analysis will examine the 
relationship between the outcomes of interest and the physical, psychosocial and economic 
variables. Correlation analysis will be used to determine significant relationships. Two separate 
multiple regression models will be developed using any variables significant at a p-value < 0.10 
in the univariate analysis. The outcomes will be from the 18-month visit, whereas the predictor 
variables will be those recorded at baseline. These analyses will be used to describe those 
characteristics of Veteran’s most likely to benefit from obtaining a SD compared to control 
subjects.  
 
Power analysis for Hypotheses 1: All power analyses were completed with PASS 6.081. Given a 
minimum sample size of 65 (per group), and an alpha of 0.05, we have over 80 percent power to 
detect differences in socioeconomic characteristics. This power analysis is based on changes in 
mean and SD (PCL-C) from prior published studies. This power analysis allows for the addition 
of three covariates to be added to the model.  
 
Hypothesis 2A: Individuals partnered with SDs will have decreased mental health care 
utilization, over time. We expect the SD group to experience diminished healthcare utilization 
over time. A within subject repeated measures will be completed to determine changes over time 
for healthcare utilization. 
 
Hypothesis 2B: Individuals partnered with SDs will have decreased overall health care 
utilization, over time. We expect the SD group to experience diminished healthcare utilization 
over time.  A within subject repeated measures will be completed to determine changes over time 
for healthcare utilization. 

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Dogs and PTSD: V11: 11.26.14 
 
 
 
Exploratory Aim: We will compare our findings to data collected in similar study entitled, “A 
Study of Dog Adoption in Veterans with Posttraumatic Stress Disorder” which is being conducted 
by Stephen Stern, MD at the South Texas Veterans Healthcare System in San Antonio, TX.  This 
is a 2-year pilot study examining the use of shelter dog adoption as a supplement to standard care 
in reducing PTSD symptoms in Veterans.  24 veterans will be randomized to adopt a dog from the 
Humane Society while another 24 (control group) will be randomized to a wait-list and be eligible 
to adopt a dog after 3 months.  Outcome measures will be assessed at baseline and at 3 intervals 
(1, 3, and 6 months post-randomization) for Veterans in the experimental group and 4 intervals (1, 
3, 4, and 6 months) for those in the control group.  Data collection will be in the form of face-to-
face interview as well as self administered paper forms.  CPRS records will be reviewed for 
changes in mental health treatments, medications, diagnoses, and other health related 
variables.  Analysis will be completed which will examine similar measures (e.g. PCL checklist, 
depression, community integration) across our Veterans who received service dogs at three time 
points (baseline, three and six months) to their Veterans who received dogs as pets. As this is an 
exploratory analysis, power analysis was not completed.  
 
Resources  
The James A. Haley Veteran’s Hospital in Tampa, Florida is a 341-bed tertiary care teaching 
hospital, with a 268 bed nursing home care unit, 50 domiciliary beds, and a 21 suite Fisher 
House affiliated with the University of South Florida. The HSR&D/RR&D Research Center of 
Excellence (COE), Maximizing Rehabilitation Outcomes, is comprised of 115 offices and 5 
conference rooms. The new facility houses three clinical areas that serve patients, including the 
Falls Clinic, the Amputee Clinic and the Prosthetics Lab. The COE also contains the Consortium 
for Health Informatics Research (CHIR), one of seven national VA sites for research using text 
and data mining of the electronic medical record, and research methodology support for all 
studies. It is located five miles from the medical center and houses the necessary software and 
hardware for health services research including high-end personal computers, research software 
support, a T-1 connection to the facility’s servers and a restricted access shared network for data 
warehousing. A safety and data monitoring board will be formed to review study progress and 
ensure well being of the study participants. 
3.0 
Progress Report 
Not applicable 
 
4.0 
Human Subjects 
1. Risk to Subjects 
• Human subject involvement and characteristics: Subjects will be asked to participate in 
this study for approximately two years which includes a screening visit, multiple baseline 
data collection pre intervention and additional follow up sessions at 3, 9, 12, 18, and 24 
months. As described in the methods section, all subjects will be Veterans who are in 
treatment for PTSD at the Tampa VA. Inclusion/exclusion criteria is described in the 
methods section. All Veterans will be accepted into the study regardless of race and/or 
gender.  

25 
 
Dogs and PTSD: V11: 11.26.14 
 
 
• Sources of Materials: Research material will be obtained from the subject’s electronic 
medical record as well as data collected from the individual subjects.  The data will be 
obtained specifically for research purposes. 
• Potential Risks: This study is a minimal risk study. Subjects are required to complete 
questionnaires over 2 years.  
 
2. Adequacy of Protection from Risk 
• Recruitment and Informed Consent:  Subjects will be recruited through direct referral as 
well as flyers in the Tampa VA PTSD clinic. Subjects interested in participation will 
contact the Project Manager.  If eligible, the subject will be scheduled to come to Center 
of Excellence and complete a screening visit. If the subject qualifies, s/he will be asked to 
sign an informed consent by the Data Collector.  The Research Consent will be noted in 
the subject’s electronic medical record. Additional details of recruitment have been 
included in the methods section of the grant. 
• Protection against Risk: On our research team, we have a psychiatrist who has extensive 
experience in individuals with PTSD. The psychiatrist will be available for help if 
needed. We have also built in methods to ensure that the SDs are being appropriately 
cared for throughout the study enrollment. This includes speaking to the Veterans 1 and 2 
months after dog placement to ensure dog behavior is appropriate, visiting Veterans who 
are paired with dogs to ensure the pairing is appropriate, and completing the assessment 
of lethality at that visit to ensure Veterans continued well being. We also have contact 
information for all clinicians and their Service Chiefs, in the event we need to reach 
clinical help. We will be complying with agencies requirements that the SDs are only 
placed with eligible Veterans.  
 
Subjects will be issued a coded identifier, which will be known only to the PI, data 
manager, and clerk. All records and the informed consent documents will be retained in 
locked files in the data manager’s office. All computer data will be encrypted to protect 
patient confidentiality. HIPAA regulations will be strictly adhered to. Data will be secure 
on a networked computer system behind two firewalls, and access will be restricted and 
password protected.   
 
• Potential Benefits of Research to Subjects and Others We do not know if there are 
potential benefits to subjects or others. We expect that those who receive the service dogs 
will receive benefits, but this study is being proposed to answer that question.  
 
• Importance of Knowledge to Be Gained This clinical trial is the first to examine SDs with 
a Veteran population with PTSD. Prior to the OEF/OIF conflict, the VA had 
approximately 500 Veterans receiving services for PTSD, depression or other anxiety 
issues.  As of April 2010, this has increased 200-fold, with over 87,000 Veterans in the 

26 
 
Dogs and PTSD: V11: 11.26.14 
 
 
VA system receiving services for PTSD, depression or other anxiety issues.  Of these, 
approximately 90% are OEF/OIF Veterans. Healthcare costs associated with mental 
health care in the VA are significant. From FY 1991-2000, the VA incurred 
approximately $10 million dollars in costs associated with mental health care. Since the 
start of the OEF/OIF wars, these costs are estimated to be between $7 and $9 billion. 
Mental health care among the OEF/OIF population is a priority for the VA, as the 
OEF/OIF Veteran population is growing exponentially.  The VA Mental Health System 
of Care mission is to maintain and improve the health and well-being of Veterans through 
excellence in health care, social services, education, and research.  There are many gaps 
in knowledge of the treatment and management of Veterans with chronic mental health 
issues, and research efforts are needed to address these gaps in an effort to lead to 
improved outcomes, and gain a better understanding of factors that impact health, 
function, and quality of life.  
 
• Data Safety Monitoring Board (DSMB). In response to the adverse events, a DSMB has 
been formed. Members include veterinarians, a social worker, and a 
psychologist/statistician. The Board will meet quarterly via teleconference.  
5.0      Vertebrate Animals 
Although dogs will be used in this study, they will not be housed on VA premises. All training 
and placement of service dogs is completed by a contracted vendor (s). No experimentation will 
done on any animals.  
 
6.0 
Multiple PI Leadership 
 
There is only one Principal Investigator for this study.  
 
7.0  
Consortium/Contractual Agreements  
There are none. 
 
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