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

Primary Purpose

Post Traumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Service Dog or Emotional Support Dog
Emotional Support Dog
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Traumatic Stress Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA
  • Iowa City VA Health Care System, Iowa City, IA
  • VA Portland Health Care System, Portland, OR
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Emotional Support Dogs

Service Dogs

Outcomes

Primary Outcome Measures

The primary outcome measures are limitations of activities and quality of life.
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
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.

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2014
Last Updated
August 14, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02039843
Brief Title
Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?
Acronym
SDPTSD
Official Title
Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2014 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Emotional Support Dogs
Arm Title
2
Arm Type
Active Comparator
Arm Description
Service Dogs
Intervention Type
Other
Intervention Name(s)
Service Dog or Emotional Support Dog
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Emotional Support Dog
Intervention Description
-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.
Primary Outcome Measure Information:
Title
The primary outcome measures are limitations of activities and quality of life.
Description
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.
Time Frame
3 years
Title
quality of life
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Secondary outcomes include PTSD severity and symptoms, depression, sleep, suicide intent, healthcare utilization, healthcare cost, and employment.
Description
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.
Time Frame
3 years
Title
Suicidal Ideation
Description
Will examine suicidal ideation, which will be assessed by the Columbia-Suicide Severity Rating Scale.
Time Frame
3 years
Title
Depression
Description
Hypothesis 2c examines depression, will be assessed by the Patient Health Questionnaire.
Time Frame
3 years
Title
Sleep Quality
Description
Hypothesis 2d will to measure sleep quality as assessed by the Pittsburgh Sleep Quality Index.
Time Frame
3 years
Title
Healthcare Utilization
Description
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.
Time Frame
3 years
Title
Employment
Description
Employment outcomes will be examined with the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Richerson, DVM
Organizational Affiliation
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Official's Role
Study Chair
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2208
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28844986
Citation
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.
Results Reference
result

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