Clinical trial NCT02039843: Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?
Official title: Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorders
Keywords: Post Traumatic Stress Disorder
Service Dog
Emotional Support Dog
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-01-20
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 the completion of activities of daily living and instrumental activities of daily living. Service Dogs are efficacious for individuals with disabilities, such as vision limitations, spinal cord injury and hearing problems. In addition, some mental health outcomes have improved with the introduction of a Service Dog. A research study was mandated in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies Program, the proponents have designed a research study to effectively meet the demands of the Bill and to provide timely research into an evolving field.

Detailed description: Background: 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 the completion of activities of daily living and instrumental activities of daily living. Service Dogs are efficacious for individuals with disabilities, such as vision limitations, spinal cord injury and hearing problems. In addition, some mental health outcomes have improved with the introduction of a Service Dog. A research study was mandated in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies Program, the proponents have designed a research study to effectively meet the demands of the Bill and to provide timely research into an evolving field.

Study Primary Objective: 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.

Study Design: A prospective randomized study is proposed which has two randomized arms. Arm one of the study will be Veterans (n=110) randomized and paired with a Service Dog, which has been trained in 5 PTSD-specific tasks to assist with the Veteran's PTSD issues. Arm two (n=110) of the study will be Veterans randomized and paired with an Emotional Support Dog (a dog that provides support via emotional comfort). All Veterans, after confirmation of eligibility, will be randomized to receive a Service Dog or Emotional Support Dog and will be observed for a minimum of three months prior to receiving their dog. During this observation period, Veterans will be required to participate in a Dog Care Course to ensure they are aware of the demands dogs place on humans. Once a dog becomes available, the Veteran will be paired with a Service Dog or Emotional Support Dog. Pairing is the training process in which the Veteran is given instruction and practice in commanding and caring for their new service dog or emotional support dog. The pairing process for a service dog takes place at the contracted dog vendor's location; the pairing process for an emotional support dog takes place at the Veteran's home, facilitated by a VA Dog Trainer. Follow-up with the Veteran begins one week post pairing to track any dog behavior issues, and will continue after pairing for 18 months. Primary outcomes to be examined include limitations on Veteran activity (as measured by the WHO-DAS 2.0) and quality of life (measured by the VR-12). Secondary outcomes include PTSD symptoms (measured by the PCL-5), suicidal ideation (C-SSRS); depression (PHQ-9) and Sleep (PSQI). In addition, health care utilization, anger management (DAR), employment, and work productivity will also be examined. Study outcomes are assessed at baseline (prior to randomization), and at 3-month intervals after a Veteran is paired with a dog until 18 months post pairing. This multi-site study will be conducted at three locations nationwide.

Eligibility criteria: Inclusion Criteria:

1. Males and Females greater than\> 18 years of age.
2. Referral from Mental Health provider that documents PTSD.
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 a 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 potential participant 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 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 training site for pairing.

    * If potential participant'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.
13. Individual has no household pets that would 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 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.
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 potential participant 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 chart note 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.

Primary outcomes:
measure: World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS)
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS)
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI) Global Score
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Dimensions of Anger Reactions (DAR) Score
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Percentage of Participants With a Non-VA Hospitalization
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers.
timeFrame: 540 days starting on the pairing date; summarized into six 90-day periods
measure: Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers
timeFrame: 540 days starting on the pairing date; summarized into six 90-day periods
measure: Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers
timeFrame: 540 days starting on the pairing date; summarized into six 90-day periods
measure: Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers
timeFrame: 540 days starting on the pairing date; summarized into six 90-day periods
measure: Total Cost of VA Healthcare (Inpatient and Outpatient)
timeFrame: 540 days starting on the pairing date; summarized into six 90-day periods
measure: Percentage of Days Covered for Antidepressants
timeFrame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
measure: Percentage of Days Covered for Antipsychotics
timeFrame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
measure: Percentage of Days Covered for Benzodiazepines
timeFrame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
measure: Percentage of Days Covered for Other Sedatives
timeFrame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
measure: Number of Veterans Employed
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
measure: Impact of Health on Work Productivity Score
timeFrame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Iowa City
country: United States
facility: Iowa City VA Health Care System, Iowa City, IA
state: Iowa
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
state: Tennessee
Study officials:
affiliation: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
name: Joan Richerson, DVM
role: STUDY_CHAIR
References:
citation: Saunders GH, Biswas K, Serpi T, McGovern S, Groer S, Stock EM, Magruder KM, Storzbach D, Skelton K, Abrams T, McCranie M, Richerson J, Dorn PA, Huang GD, Fallon MT. Design and challenges for a randomized, multi-site clinical trial comparing the use of service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD). Contemp Clin Trials. 2017 Nov;62:105-113. doi: 10.1016/j.cct.2017.08.017. Epub 2017 Aug 26.