Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post Traumatic Stress Disorders
- Sponsor
- VA Office of Research and Development
- Enrollment
- 287
- Locations
- 4
- Primary Endpoint
- Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Exclusion Criteria
- •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.
- •Aggressive behavior that would make it unsafe for dog.
- •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.
- •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.
Outcomes
Primary Outcomes
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS)
Time Frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The PCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life.
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS)
Time Frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The MCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life.
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score
Time Frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
The World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) is a standardized measure for assessing health and disability levels. For the WHO-DAS 2.0 36-item, self-administered questionnaire, participants rate the difficulty they experience with each item on a 5-item scale: 'None,' 'Mild,' 'Moderate,' 'Severe' or 'Extreme/cannot do.' Standardized total disability scores ranging from 0 (no disability) to 100 (full disability) are obtained (WHO-DAS 2.0 manual, 2012).
Secondary Outcomes
- Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers.(540 days starting on the pairing date; summarized into six 90-day periods)
- Percentage of Days Covered for Benzodiazepines(Baseline: The 540 days prior to pairing Follow up: Pairing through day 540)
- Number of Veterans Employed(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Patient Health Questionnaire (PHQ-9) Score(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers(540 days starting on the pairing date; summarized into six 90-day periods)
- Total Cost of VA Healthcare (Inpatient and Outpatient)(540 days starting on the pairing date; summarized into six 90-day periods)
- Pittsburgh Sleep Quality Index (PSQI) Global Score(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers(540 days starting on the pairing date; summarized into six 90-day periods)
- Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers(540 days starting on the pairing date; summarized into six 90-day periods)
- Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Dimensions of Anger Reactions (DAR) Score(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Percentage of Participants With a Non-VA Hospitalization(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Impact of Health on Work Productivity Score(Baseline and every 3 months after dog pairing up to 18 months post-pairing)
- Percentage of Days Covered for Antidepressants(Baseline: The 540 days prior to pairing Follow up: Pairing through day 540)
- Percentage of Days Covered for Other Sedatives(Baseline: The 540 days prior to pairing Follow up: Pairing through day 540)
- Percentage of Days Covered for Antipsychotics(Baseline: The 540 days prior to pairing Follow up: Pairing through day 540)