Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?

Post Traumatic Stress Disorders Clinical Trial

— SDPTSD  

Official title:

Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039843
• Other study ID #: SDPTSD
• Status: Completed
• Phase: N/A
• Start date: December 15, 2014
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Emotional Support Dogs
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
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).

Locations

Country	Name	City	State
United States	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	Tennessee Valley Healthcare System Nashville Campus, Nashville, TN	Nashville	Tennessee
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 ser — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Primary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Primary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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).	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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.	540 days starting on the pairing date; summarized into six 90-day periods
Secondary	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.	540 days starting on the pairing date; summarized into six 90-day periods
Secondary	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.	540 days starting on the pairing date; summarized into six 90-day periods
Secondary	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.	540 days starting on the pairing date; summarized into six 90-day periods
Secondary	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.	540 days starting on the pairing date; summarized into six 90-day periods
Secondary	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).	Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Secondary	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).	Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Secondary	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).	Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Secondary	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).	Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Secondary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing
Secondary	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.	Baseline and every 3 months after dog pairing up to 18 months post-pairing