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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02039843
First received: January 7, 2014
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Post Traumatic Stress Disorders
Other: Service Dog or Emotional Support Dog
Other: Emotional Support Dog

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The primary outcome measures are limitations of activities and quality of life. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    1a: The total score and six domain scores as measured by the World Health Organization Disability Assessment Scale II will define activity limitations. The WHO-DAS 2.0 is a structured 36-item instrument, which assesses difficulties in six domains of life during the last 30 days.

    1b: The outcome measure will be the summary measures from the VR-12 instrument of health related quality of life as measured by both the Physical Component Summary and Mental Component Summary scores.


  • limitations on quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    1b: The outcome measure will be the summary measures from the VR-12 instrument of health related quality of life as measured by both the Physical Component Summary and Mental Component Summary scores.


Secondary Outcome Measures:
  • Secondary outcomes include PTSD severity and symptoms, depression, sleep, suicide intent, healthcare utilization, healthcare cost, and employment. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    2a: The outcome measure will be the Posttraumatic Stress Disorder Checklist. PCL-S is a 17-item self-report measure of PTSD symptoms (in the past month) based on DSM-IV criteria with a 5-point Likert scale response format.

    Hypothesis 2b will examine suicidal ideation, which will be assessed by the Columbia-Suicide Severity Rating Scale.

    Hypothesis 2c examines depression, will be assessed by the Patient Health Questionnaire.

    Hypothesis 2d will to measure sleep quality as assessed by the Pittsburgh Sleep Quality Index.

    Hypotheses 3a and 3b: Information on healthcare utilization and costs will be collected from VA administrative data sets and with the Health Economics Resource Center - standard questions regarding non-VA outpatient and inpatient utilization.

    Hypotheses 4a,4b: Employment outcomes will be examined with the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0.


  • Suicidal Ideation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    2b will examine suicidal ideation, which will be assessed by the Columbia-Suicide Severity Rating Scale.

  • Depression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Hypothesis 2c examines depression, will be assessed by the Patient Health Questionnaire.

  • Sleep Quality [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Hypothesis 2d will to measure sleep quality as assessed by the Pittsburgh Sleep Quality Index.

  • Healthcare Utilization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Information on healthcare utilization and costs will be collected from VA administrative data sets and with the Health Economics Resource Center - standard questions regarding non-VA outpatient and inpatient utilization.

  • Employment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Employment outcomes will be examined with the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0.


Estimated Enrollment: 220
Study Start Date: January 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Emotional Support Dogs
Other: Service Dog or Emotional Support Dog

Emotional Support Dog. Service Dog - an assistance dog specifically trained to perform tasks that are specific to the person's disability and has public access privileges.

-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.

Other: Emotional Support Dog
-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.
Active Comparator: 2
Service Dogs
Other: Service Dog or Emotional Support Dog

Emotional Support Dog. Service Dog - an assistance dog specifically trained to perform tasks that are specific to the person's disability and has public access privileges.

-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.

Other: Emotional Support Dog
-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.

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 three-year prospective randomized study is proposed which has two randomized arms. Arm one of the study will be Veterans (n=110) randomized to receiving a Service Dog, which has been trained for specific tasks to assist with the Veteran's disability. Arm two (n=110) of the study will be Veterans randomized to receive an Emotional Support Dog (a dog which provide emotional comfort). All Veterans, after confirmation of eligibility will be observed a minimum of three months. During this 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 dogs become available, Veterans will be randomized to be paired with a Service Dog or Emotional Support Dog. Follow-up will begin at one month post pairing to track any dog behavior issues, and will continue every three months after pairing for 18 months. Primary outcomes to be examined include limitations on activity (as measured by the WHO- DAS 2.0), quality of life (measured by the VR-12). Secondary outcomes include PTSD symptoms (measured by the PCL-S), Suicidal ideation (Columbia-Suicide Severity Rating Scale); depression (PHQ-9) and Sleep (Pittsburgh Sleep Quality Index). In addition, health care utilization, anger management, employment and productivity will also be examined. This multi-site study will be conducted at three locations, Nationwide.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and Females greater than> 18 years of age
  • Referral from Mental Health provider that documents PTSD diagnosis is needed. Must meet all items on referral checklist (anger management; cognitive ability; exclusion of suicidal plan, delusions, psychoses, dementia, alcohol/substance dependence.
  • PTSD as a result of any trauma
  • PTSD diagnosed by CAPS (Meets criteria for DSM V current PTSD).
  • Enrolled in mental health services at VA and has attended at least one visit in the past 90 days prior to consent.
  • Agrees to remain in mental health treatment throughout the duration of the study
  • Ability to adequately care for a dog (physically and financially). Please note, an individual may have a physical impairment, (e.g., use a wheelchair), but Service Dogs will not be trained to accommodate for those disabilities.
  • Has lived in home for over six consecutive months and has suitable home environment to provide for a dog.
  • Home environment must be accessible for study staff
  • Willing to accept randomization outcome, thus willing to attend either a training session for potential receipt of Service Dog that lasts two weeks or a weekly obedience class to learn commands for their Emotional Support Dog.
  • Has someone to care for dog in the absence of Veteran
  • Agreement by others in home to have dog
  • Willing and able to travel (by air or car) to training site for pairing
  • Acceptance by dog vendors to receive dog. Note, additional criteria may be added because of the vendors who provide the dogs. At this time, the vendors are unknown. When the vendors are selected, eligibility criteria will be reviewed and consensus obtained on additional criteria.
  • Subject has no pets (cats, dogs or horses), but wants a dog.
  • Able to verbalize understanding of consent form, willingness to complete study questionnaires, and provide written informed consent

Exclusion Criteria:

  • Hospitalization for mental health reasons in the past 6 months
  • Aggressive behavior on the part of the Veteran that would make it unsafe for dog
  • Diagnosis of psychoses, delusions, dementia, active alcohol/substance dependence, or moderate to severe traumatic brain injury as documented by chart review
  • Active suicidal or homicidal intent, or cognitive disabilities that would preclude safety of dog and ability to participate in the study
  • Suicide flag in VA medical record
  • Site PI identifies a social, mental or physical condition that prevents Veteran from either giving informed consent or participating in the study.
  • Participating in another research trial
  • Has the National CPRS flag for violent/disruptive behavior
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039843

Contacts
Contact: Alexander V Libin, PhD (301) 951-8603 Alexander.Libin2@va.gov
Contact: Kathryn M Magruder, PhD MPH BA (843) 789-7280 Kathryn.Magruder@va.gov

Locations
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC Active, not recruiting
Washington, District of Columbia, United States, 20422
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Not yet recruiting
Decatur, Georgia, United States, 30033
Contact: Bekh Bradley, PhD    404-321-6111 ext 7935    bekh.bradley@va.gov   
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA Not yet recruiting
Iowa City, Iowa, United States, 52246-2208
Contact: Thad Abrams, MD    319-338-0581    thad.abrams@va.gov   
United States, Oregon
Portland VA Medical Center, Portland, OR Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Daniel Storzbach, PhD       Daniel.Storzbach@v.gova   
Sponsors and Collaborators
Investigators
Study Chair: Alexander V Libin, PhD Washington DC VA Medical Center, Washington, DC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02039843     History of Changes
Other Study ID Numbers: SDPTSD
Study First Received: January 7, 2014
Last Updated: July 3, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014