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

• ClinicalTrials.gov Identifier: NCT02039843
• Recruitment Status: Completed
• First Posted: January 20, 2014
• Last Update Posted: August 15, 2019
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: January 7, 2014
• First Posted Date: January 20, 2014
• Last Update Posted Date: August 15, 2019
• Actual Study Start Date: December 15, 2014
• Actual Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2015)

• The primary outcome measures are limitations of activities and quality of life. [ Time Frame: 3 years ]
  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.
• quality of life [ Time Frame: 3 years ]
  The outcome measure will be the summary measures from the Veteran's Rand 12 item Health Survey (VR-12) as measured by both the Physical Component Summary and Mental Component Summary scores.

Original Primary Outcome Measures (submitted: January 16, 2014)

• The primary outcome measures are limitations of activities and quality of life. [ Time Frame: 3 years ]
  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 ]
  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.

Current Secondary Outcome Measures (submitted: February 10, 2015)

• Secondary outcomes include PTSD severity and symptoms, depression, sleep, suicide intent, healthcare utilization, healthcare cost, and employment. [ Time Frame: 3 years ]
  The outcome measure for PTSD severity will be the Posttraumatic Stress Disorder Checklist. PCL is a 20-item self-report measure of PTSD symptoms (in the past month) based on DSM-IV criteria with a 5-point Likert scale response format.
• Suicidal Ideation [ Time Frame: 3 years ]
  Will examine suicidal ideation, which will be assessed by the Columbia-Suicide Severity Rating Scale.
• Depression [ Time Frame: 3 years ]
  Hypothesis 2c examines depression, will be assessed by the Patient Health Questionnaire.
• Sleep Quality [ Time Frame: 3 years ]
  Hypothesis 2d will to measure sleep quality as assessed by the Pittsburgh Sleep Quality Index.
• Healthcare Utilization [ Time Frame: 3 years ]
  Along with the Health Economics Resource Center information healthcare utilization and costs will be collected from VA administrative data sets and from standard questions regarding non-VA outpatient and inpatient utilization.
• Employment [ Time Frame: 3 years ]
  Employment outcomes will be examined with the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0.

Original Secondary Outcome Measures (submitted: January 16, 2014)

• Secondary outcomes include PTSD severity and symptoms, depression, sleep, suicide intent, healthcare utilization, healthcare cost, and employment. [ Time Frame: 3 years ]
  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 ]
  2b will examine suicidal ideation, which will be assessed by the Columbia-Suicide Severity Rating Scale.
• Depression [ Time Frame: 3 years ]
  Hypothesis 2c examines depression, will be assessed by the Patient Health Questionnaire.
• Sleep Quality [ Time Frame: 3 years ]
  Hypothesis 2d will to measure sleep quality as assessed by the Pittsburgh Sleep Quality Index.
• Healthcare Utilization [ Time Frame: 3 years ]
  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 ]
  Employment outcomes will be examined with the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?
• Official Title: Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?
• 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 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 randomized to receive a Service Dog or Emotional Support Dog and 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 paired with a Service Dog or Emotional Support Dog. Follow-up will begin at 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 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), 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Post Traumatic Stress Disorders

Intervention

• 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.

Study Arms

• Active Comparator: 1
  Emotional Support Dogs
  Interventions:

  • Other: Service Dog or Emotional Support Dog
  • Other: Emotional Support Dog
• Active Comparator: 2
  Service Dogs
  Interventions:

  • Other: Service Dog or Emotional Support Dog
  • Other: Emotional Support Dog

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2019): 287
• Original Estimated Enrollment (submitted: January 16, 2014): 220
• Actual Study Completion Date: June 30, 2019
• Actual Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)

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
• 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 accessible for study staff
• If a participant moves home while enrolled in the study, the new home must be geographically accessible to study staff.
• Is willing to accept randomization outcome..
• Has someone to care for dog in a long-term absence
• If no one is available to care for the dog but the situation changes then the participant may become eligible to participate.
• 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
• 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.
• Individual has no household pets that would threaten the dog-human bonding process
• If an individual has household pets but the situation changes, the individual may become eligible to participate
• 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, the individual can be eligible.
• If an individual has pets other than dogs that could interfere with bonding, the individual will be scheduled for 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.
• If can verbalize understanding of consent form, is willing to provide written informed consent and to follow study procedures.

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, active alcohol/substance dependence, or moderate to severe traumatic brain injury
• Active suicidal intent as determined by a CPRS flag for suicidal intent or a score 5 on the C-SSRS completed at the baseline visit
• 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 research trial
• If a participant 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 the study.
• Has chart note flag for violent/disruptive behavior
• Potential participants who are pregnant/who have a partner who is pregnant, or who currently have one or more children younger than the age of 5 in the household for more than 8 hours per , 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.
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02039843
• Other Study ID Numbers: SDPTSD
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: US Department of Veterans Affairs
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: US Department of Veterans Affairs
• Collaborators: Not Provided

Investigators

• Study Chair: Joan Richerson, DVM; Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

• PRS Account: VA Office of Research and Development
• Verification Date: August 2019