Clinical trial NCT03777020: Service Dog Training Program for Military Veterans With PTSD
Official title: Evaluating the Efficacy of a Service Dog Training Program for Military Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: human-animal interaction
service dog
stress
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-traumatic stress disorder (PTSD), an invisible wound of war, affects approximately 20%1 of the 18.5 million U.S. veterans and places them at higher risk for impaired biopsychosocial functioning. PTSD symptom severity (PTSDSS) is significantly correlated with stress and psychosocial consequences of inability to regulate emotions, control impulsive behaviors, and function within family and society. Alarming veteran PTSD rates and its insidious effects demand empirically validated treatment programs. More than a million veterans receive new diagnoses of each year. VA PTSD therapy programs reach only 1% of veterans. Nearly 35% of veterans do not respond to widely used psychotherapy and pharmacotherapy treatments. Training a service dog (SD) is a novel rehabilitative animal-assisted intervention that shows promise in other populations. This project evaluates the efficacy of a service dog training program (SDTP) as an alternative and adjunctive treatment and rehabilitative option for veterans with PTSD.

Detailed description: Veterans with PTSD attend 8 weekly sessions of either training a service dog or learning about how to train a dog at the Warrior Canine Connection facility in Boyds MD. They complete questionnaires prior to the start of the program and at the midpoint (after 4 sessions) and end of the program (after 8 sessions). Participants also wear a monitor to record heart rate variability during the 1st, 4th, and 8th sessions and provide saliva samples at these same times.

Eligibility criteria: Inclusion Criteria

1. Accepted into the Warrior Canine Connection Service Dog Training Program. Their inclusion criteria are:

   1. military veteran;
   2. diagnosis of PTSD;
   3. able to give informed consent; and
   4. able to understand English; And
2. Military Veteran

Exclusion Criteria:

Excluded from the Warrior Canine Connection Service Dog Training Program. Their criteria are:

1. fear of dogs;
2. allergy to pet dander;
3. active substance abuse;
4. active psychosis, or
5. history of animal abuse
6. Excluded by the WCC from participation in their Service Dog Training Program because they have:

fear of dogs; allergy to pet dander; active substance abuse; active psychosis, history of animal abuse or physically unable to complete tasks required to train dogs

.

Primary outcomes:
measure: Post Traumatic Stress Symptom Severity
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Stress Biomarker Markers:Cortisol
timeFrame: Baseline, 8 weeks
measure: Stress Biomarkers: Alpha Amylase
timeFrame: Baseline, 8 weeks
measure: Stress Biomarkers: IgA
timeFrame: Baseline, 8 weeks
measure: Stress Biomarkers: HRV
timeFrame: baseline, 8 weeks
measure: Stress Marker: Perceived Stress
timeFrame: Baseline, 8 weeks
measure: Psychosocial Health: Positive Affect
timeFrame: Baseline, 8 weeks
measure: Psychosocial Health: Health Related Quality of Life
timeFrame: Baseline, 8 weeks
measure: Psychosocial Health: Resilience
timeFrame: Baseline, 8 weeks
measure: Psychosocial Health: Relationship With Friends and Family
timeFrame: Baseline, 8 weeks
measure: Psychosocial Health: Quality of Individual's Relationships
timeFrame: Baseline, 8 weeks
measure: Psychosocial Health: Satisfaction With Social Activities
timeFrame: Baseline, 8 weeks
measure: Psychosocial Health: Companionship
timeFrame: Baseline, 8 weeks
measure: Psychosocial Health:Depression
timeFrame: baseline, 8 weeks
measure: Psychosocial Health: Anxiety
timeFrame: baseline, 8 weeks
measure: Psychosocial Health: Suicidal Ideation
timeFrame: Baseline, 8 weeks
Other outcomes:
measure: Cellular Aging
timeFrame: Baseline, 8 weeks
Locations:
city: Boyds
country: United States
facility: Warrior Canine Connections
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Erika Friedmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: