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

NCT02039843 | Completed Results DMC

• 1 other identifier: SDPTSD
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 4

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.

Conditions

Post Traumatic Stress Disorders

Keywords

Post Traumatic Stress Disorder; Service Dog; Emotional Support Dog

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (19)

• Pittsburgh Sleep Quality Index (PSQI) Global Score

  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

  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

• Dimensions of Anger Reactions (DAR) Score

  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

Study Arms (2)

Emotional Support Dogs

ACTIVE COMPARATOR

Participants paired with 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.

Other: Emotional Support Dogs

Service Dogs

ACTIVE COMPARATOR

Participants paired with 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).

Other: Service Dogs

Interventions

Emotional Support Dogs OTHER

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.

Emotional Support Dogs

Service Dogs OTHER

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).

Service Dogs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Homicidal intent or cognitive disabilities that would preclude safety of dog and/or ability to participate in the study.
• Social, mental or physical condition that prevents the potential participant from either giving informed consent or participating in the study.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

Related 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 service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD). Contemp Clin Trials. 2017 Nov;62:105-113. doi: 10.1016/j.cct.2017.08.017. Epub 2017 Aug 26.

  PMID: 28844986 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Joan Richerson
• Organization: Tennesse Valley HCS

joan.richerson@va.gov

615-574-8198

Study Officials

• Joan Richerson, DVM

  Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 20, 2014
• Study Start: December 15, 2014
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)