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NCT03245814 Clinical Trial

Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD

Post Traumatic Stress Disorder Clinical Trial

Official title:
Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03245814
Other study ID # 1R21HD091896-01
Secondary ID R21HD091896-01
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date June 4, 2020

Study information
Verified date March 2024
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date June 4, 2020
Est. primary completion date June 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Service Dog
A service dog trained to perform tasks that are specific to PTSD

Locations
Country Name City State
United States University of Arizona Tucson Arizona

Sponsors (3)
Lead Sponsor Collaborator
University of Arizona Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Work and activity participation Work Productivity and Activity Impairment Questionnaire (WPAIQ) 3 months
Other Suicidal ideation Columbia Suicide Severity Rating Scale (CSSRS) 3 months
Other Sleep quality Pittsburgh Sleep Quality Assessment (PSQI) 3 months
Other Sleep disturbance Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a 3 months
Other Sleep actigraphy Actiwatch 2 (Philips Respironics) 3 months
Other Salivary cortisol awakening response Passive drool method (Salimetrics) 3 months
Other Electrodermal activity (skin conductance) Embrace wristband (Empatica, Inc.) 3 months
Primary PTSD severity and symptoms via self-report Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5) 3 months
Primary PTSD severity and symptoms via clinician rating Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5) 3 months
Primary Depression Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a 3 months
Primary Anxiety Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a 3 months
Secondary Social isolation Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a 3 months
Secondary Companionship Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a 3 months
Secondary Ability to participate in social activities Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a 3 months
Secondary Mental health quality of life Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component 3 months
Secondary Psychological well-being Bradburn Scale of Psychological Wellbeing (BSPW) 3 months
Secondary Life satisfaction Satisfaction with Life Scale (SLS) 3 months
Secondary Resilience Connor-Davidson Resilience Scale (CDRS) 3 months
Secondary Anger Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a 3 months
Secondary Daily socio-emotional experiences Ecological momentary assessment (EMA) 3 months
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