PTSD
Conditions
Keywords
PTSD, Service Dogs
Brief summary
The purpose of this study is to evaluate use of service dogs for individuals who have been diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the impact service dogs have on the mental health and quality of life of Veterans; (2) to provide recommendations to the VA to serve as guidance in providing service dogs to Veterans; and (3) To determine cost associated with total health care utilization and mental health care utilization among Veterans with PTSD.
Interventions
OTHERService Dogs
Service dogs will be trained to help Veterans with PTSD
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years * Referral from provider. * PTSD diagnosis * In active treatment for PTSD for at least three months at time of enrollment, with plans to remain in active treatment * Acceptance by the dog vendor for the service dog * Ability to adequately care for a dog - physically/financially * Able to travel to vendor for pairing with dog
Exclusion criteria
* Been hospitalized for mental health reasons in the prior 6 months * Not living at the same residence for 6 months. * Diagnoses: Psychoses, Delusions, dementia, active alcohol/substance dependence. Moderate to severe TBI. Any other diagnosis deemed by PI to limit ability to participate or give informed consent * At time of enrollment - Active suicidal ideation, homicide, cognitive disabilities that would preclude safety of animal and ability needed for participation in the study. * Children under age 10 living in the home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mental Health Outcomes | 3,6,9,12,18 and 24 months after receipt of service dog | Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms |
Countries
United States
Participant flow
Pre-assignment details
Veterans were recruited prior to receipt of ServiceDog and given questionnaires to complete. They were followed and questionnaires completed every 3 months until receipt of Service Dog.
Participants by arm
| Arm | Count |
|---|---|
| Service Dog Veterans who received a service dog | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 44 |
Baseline characteristics
| Characteristic | Service Dog |
|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 15.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 60 |
| other Total, other adverse events | 12 / 60 |
| serious Total, serious adverse events | 10 / 60 |
Outcome results
Primary
Mental Health Outcomes
Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms
Time frame: 3,6,9,12,18 and 24 months after receipt of service dog
Population: No valid data to report.