N/A
Completed N=227
Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?
Post Traumatic Stress Disorders
Source: ClinicalTrials.gov NCT02039843 ↗
Enrolled (actual)
227
Serious AEs
12.2%
Results posted
Dec 2023
Primary outcomePrimary: World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score — 38.31; 35.78; 41.76; 38.76 score on a scale — p=0.052
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score |
38.31; 35.78; 41.76; 38.76; 41.70; 36.73 | 0.052 |
| PRIMARY Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) |
40.16; 43.07; 37.14; 39.05; 35.78; 39.80 | 0.421 |
| PRIMARY Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) |
31.11; 30.68; 35.59; 35.81; 36.71; 35.71 | 0.606 |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) Global Score |
14.26; 13.60; 13.60; 12.51; 13.10; 12.17 | 0.210 |
| SECONDARY Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score |
46.98; 48.33; 41.96; 41.54; 39.66; 39.39 | 0.036 sig |
| SECONDARY Patient Health Questionnaire (PHQ-9) Score |
13.08; 12.79; 11.46; 10.95; 10.55; 10.03 | 0.079 |
| SECONDARY Dimensions of Anger Reactions (DAR) Score |
23.82; 21.85; 23.21; 22.14; 21.05; 20.35 | 0.155 |
| SECONDARY Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) |
13; 24; 22; 33; 19; 21 | 0.157 |
| SECONDARY Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers |
1.6; 1.1; 0.9; 0.5; 1.0; 0.4 | 0.430 |
| SECONDARY Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities |
0.1; 0.1; 0.1; 0.0; 0.1; 0.0 | 0.358 |
| SECONDARY Percentage of Participants With a Non-VA Hospitalization |
0; 6; 3; 5; 5; 2 | 0.39 |
| SECONDARY Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. |
16.4; 15.2; 15.1; 15.1; 14.5; 15 | — |
| SECONDARY Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers |
0; 0.1; 0; 0.1; 0; 0 | — |
| SECONDARY Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers |
4701.32; 4496.76; 3997.82; 4696.70; 3684.87; 4579.89 | — |
| SECONDARY Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers |
184.53; 1341.99; 132.36; 727.11; 803.92; 567.10 | — |
| SECONDARY Total Cost of VA Healthcare (Inpatient and Outpatient) |
4885.85; 5838.74; 4130.18; 5423.80; 4488.79; 5146.99 | — |
| SECONDARY Percentage of Days Covered for Antidepressants |
78.10; 73.90; 70.50; 77.20 | — |
| SECONDARY Percentage of Days Covered for Antipsychotics |
79.00; 72.30; 71.40; 76.30 | — |
| SECONDARY Percentage of Days Covered for Benzodiazepines |
61.60; 72.60; 54.80; 60.10 | — |
| SECONDARY Percentage of Days Covered for Other Sedatives |
66.90; 63.20; 79.10; 63.00 | — |
| SECONDARY Number of Veterans Employed |
28; 25; 27; 22; 23; 23 | 0.383 |
| SECONDARY Impact of Health on Work Productivity Score |
5.7; 3.3; 4.7; 3.4; 4.1; 3.1 | 0.932 |
Eligibility Criteria
Inclusion Criteria
- Males and Females greater than> 18 years of age.
- Referral from Mental Health provider that documents PTSD.
- PTSD as a result of any trauma as determined by meeting DSM 5 diagnostic criteria.
- 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.
- Agrees to remain in mental health treatment throughout the duration of the study
- 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.
- 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.
- 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.
- Is willing to accept randomization outcome.
- 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.
- 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.
- 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.
- 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.
- Individual can verbalize understanding of consent form, is willing to provide written informed consent and to follow study procedures.
Exclusion Criteria
- Hospitalization for mental health reasons in the past 6 months.
- Once six months since hospitalization have
Data sourced from ClinicalTrials.gov (NCT02039843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.