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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
287
Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.
Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score
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).
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS)
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.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS)
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.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Pittsburgh Sleep Quality Index (PSQI) Global Score
The Pittsburgh Sleep Quality Index (PSQI) is a self-administered survey used to assess sleep-related problems during the past month (Buysse, et al., 1989). The 19 items completed by the participant are grouped into seven components: (1) Sleep quality, (2) Sleep latency, (3) Sleep duration, (4) Habitual sleep efficiency, (5) Sleep disturbances, (6) Use of sleep medication, and (7) Daytime dysfunction. Each of the seven components are weighted equally on a 0-3 scale with 0 (better) to 3 (worse). These are summed to yield a global score with a range of 0-21 with higher scores indicating worse sleep quality.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score
The Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-5) symptoms of PTSD. Each symptom is scored on a scale of 0 (not at all) through 4 (extreme). A total symptom severity score is calculated by summing the scores for each of the 20 items. Scores can range from 0 to 80 with higher scores representing greater PTSD symptom severity.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Patient Health Questionnaire (PHQ-9) Score
The Patient Health Questionnaire (PHQ-9) assesses the severity of depression (Kroenke, et al., 2002). It consists of 9 depression symptom questions with response choices of 0 (not at all), 1 (several days), 2 (more than half of days), or 3 (nearly every day). The total score is calculated by adding together the symptom ratings for each of the 9 questions so that scores range from 0 to 27 (higher scores represent greater depression severity).
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Dimensions of Anger Reactions (DAR) Score
The 7-item Dimensions of Anger Reactions (DAR) is a seven-item scale that assesses anger disposition directed to others (Forbes, et al.,2004). For each item, participants indicate the degree to which each statement describes their feelings and behavior on an 8-point scale ranging from 0 (not at all) to 8 (exactly so). Scores are totaled yielding a range of 0 to 56 with higher scores indicating greater anger disposition.
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Time frame: 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)
The Suicidal Behavior or Ideation (SBI) indicator derived from the Columbia Suicide Severity Rating Scale (C-SSRS) is dichotomized as the presence or absence of suicidal behavior or ideation. Presence of SBI is indicated by a "Yes" response to any one of the five suicidal behavior or the five suicidal ideation questions.
Time frame: 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
Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection.
Time frame: 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
Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Percentage of Participants With a Non-VA Hospitalization
Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers.
Utilization of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 540 days starting on the pairing date; summarized into six 90-day periods
Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers
Utilization of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 540 days starting on the pairing date; summarized into six 90-day periods
Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers
Cost of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 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
Cost of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 540 days starting on the pairing date; summarized into six 90-day periods
Total Cost of VA Healthcare (Inpatient and Outpatient)
Cost of VA inpatient and outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 540 days starting on the pairing date; summarized into six 90-day periods
Percentage of Days Covered for Antidepressants
The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antidepressants are reported for this outcome (as a percentage).
Time frame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Percentage of Days Covered for Antipsychotics
The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antipsychotics are reported for this outcome (as a percentage).
Time frame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Percentage of Days Covered for Benzodiazepines
The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for benzodiazepines are reported for this outcome (as a percentage).
Time frame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Percentage of Days Covered for Other Sedatives
The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for other sedatives are reported for this outcome (as a percentage).
Time frame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Number of Veterans Employed
Employment assessed using the question "Are you currently employed (working for pay)?" from the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Sample size (n) reflects the number of participants who provided work productivity and employment information at the time of data collection.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Impact of Health on Work Productivity Score
Impact of Health on Work Productivity was assessed using the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Only participants who were employed were included in this analysis. Scores can range from 0 (no impact of health on work productivity) to 10 (extreme impact of health on work productivity), so a higher score represents a greater impact of health on work productivity.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing