- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03245814
Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
March 27, 2024 updated by: Maggie O'Haire, University of Arizona
The purpose of this study is to quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The long-term research goal is to evaluate the safety and efficacy of service dogs as a complementary intervention to enhance biopsychosocial functioning in special populations.
The objective is to conduct a methodologically rigorous trial to quantify the therapeutic efficacy of service dogs on clinically-important outcomes for veterans with PTSD.
Based on preliminary findings and qualitative reports, the central hypothesis is that military veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms related to socio-emotional functioning and arousal modulation.
The rationale for this research is that its successful completion will provide an evidence-based demonstration of the efficacy and role of an increasingly used yet poorly tested complementary intervention.
The completion of this project is expected to established an initial demonstration of the therapeutic efficacy of service dogs in this population, as well as possible mechanisms of action via specific biological pathways and human-canine interaction profiles.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- University of Arizona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria for veterans into the study will include:
- Applied for and approved to receive a dog from K9s For Warriors
- Military service on or after September 11, 2001
- Honorable discharge or current honorable service
- Diagnosis of PTSD
- No conviction of any crimes against animals.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Service Dog
Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog.
|
A service dog trained to perform tasks that are specific to PTSD
|
No Intervention: Waitlist Control
Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD severity and symptoms via self-report
Time Frame: 3 months
|
Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
|
3 months
|
PTSD severity and symptoms via clinician rating
Time Frame: 3 months
|
Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5)
|
3 months
|
Depression
Time Frame: 3 months
|
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a
|
3 months
|
Anxiety
Time Frame: 3 months
|
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social isolation
Time Frame: 3 months
|
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a
|
3 months
|
Companionship
Time Frame: 3 months
|
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a
|
3 months
|
Ability to participate in social activities
Time Frame: 3 months
|
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a
|
3 months
|
Mental health quality of life
Time Frame: 3 months
|
Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component
|
3 months
|
Psychological well-being
Time Frame: 3 months
|
Bradburn Scale of Psychological Wellbeing (BSPW)
|
3 months
|
Life satisfaction
Time Frame: 3 months
|
Satisfaction with Life Scale (SLS)
|
3 months
|
Resilience
Time Frame: 3 months
|
Connor-Davidson Resilience Scale (CDRS)
|
3 months
|
Anger
Time Frame: 3 months
|
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a
|
3 months
|
Daily socio-emotional experiences
Time Frame: 3 months
|
Ecological momentary assessment (EMA)
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Work and activity participation
Time Frame: 3 months
|
Work Productivity and Activity Impairment Questionnaire (WPAIQ)
|
3 months
|
Suicidal ideation
Time Frame: 3 months
|
Columbia Suicide Severity Rating Scale (CSSRS)
|
3 months
|
Sleep quality
Time Frame: 3 months
|
Pittsburgh Sleep Quality Assessment (PSQI)
|
3 months
|
Sleep disturbance
Time Frame: 3 months
|
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a
|
3 months
|
Sleep actigraphy
Time Frame: 3 months
|
Actiwatch 2 (Philips Respironics)
|
3 months
|
Salivary cortisol awakening response
Time Frame: 3 months
|
Passive drool method (Salimetrics)
|
3 months
|
Electrodermal activity (skin conductance)
Time Frame: 3 months
|
Embrace wristband (Empatica, Inc.)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marguerite O'Haire, Ph.D., University of Arizona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
June 4, 2020
Study Completion (Actual)
June 4, 2020
Study Registration Dates
First Submitted
July 5, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 10, 2017
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21HD091896-01 (U.S. NIH Grant/Contract)
- R21HD091896-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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