Clinical trial NCT03245814: Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
Official title: Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: service dogs
human-animal interaction
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-08-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PTSD Severity and Symptoms Via Self-report
timeFrame: 3 months
measure: PTSD Severity and Symptoms Via Clinician Rating
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
Secondary outcomes:
measure: Social Isolation
timeFrame: 3 months
measure: Companionship
timeFrame: 3 months
measure: Ability to Participate in Social Activities
timeFrame: 3 months
measure: Mental Health Quality of Life
timeFrame: 3 months
measure: Psychological Well-being
timeFrame: 3 months
measure: Life Satisfaction
timeFrame: 3 months
measure: Resilience
timeFrame: 3 months
measure: Anger
timeFrame: 3 months
measure: Daily Socio-emotional Experiences
timeFrame: 3 months
Other outcomes:
measure: Work and Activity Participation
timeFrame: 3 months
measure: Suicidal Ideation
timeFrame: 3 months
measure: Sleep Quality
timeFrame: 3 months
measure: Sleep Disturbance
timeFrame: 3 months
measure: Sleep Actigraphy
timeFrame: 3 months
measure: Salivary Cortisol Awakening Response
timeFrame: 3 months
measure: Electrodermal Activity (Skin Conductance)
timeFrame: 3 months
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Marguerite O'Haire, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: