Service Dog Training Program for Military Veterans With PTSD

Not Applicable

Completed

Conditions: Post Traumatic Stress Disorder

Registration Number: NCT03777020

Lead Sponsor: University of Maryland, Baltimore

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

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

fear of dogs;
allergy to pet dander;
active substance abuse;
active psychosis, or
history of animal abuse
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post Traumatic Stress Symptom Severity	Baseline, 8 weeks	Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)

Secondary Outcome Measures

Name	Time	Method
Stress Biomarkers: Alpha Amylase	Baseline, 8 weeks	salivary alpha amylase U/mL; higher is more stress
Stress Biomarkers: HRV	baseline, 8 weeks	Heart rate variability Polar H7 heart rate sensor worn around the chest and matching Polar V800 GPS Sports Watch, higher is better
Psychosocial Health: Resilience	Baseline, 8 weeks	Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient
Psychosocial Health: Relationship With Friends and Family	Baseline, 8 weeks	Relationship Scale Questionnaire (RSQ) , 4 subscales are created from average of items: Secure scale is the average of 3, 9(Reverse),10, 15, 28(Reverse). Fearful scale is the average of 1, 5, 12, 24. Preoccupied scale is the average of 6(Reverse), 8, 16, 25. Dismissing scale is the average of 2, 6, 19, 22, 26. Subscale scores range from 1 to 5. Higher scores are poorer relationships
Stress Biomarkers: IgA	Baseline, 8 weeks	salivary immunoglobulin A μg/mL; higher is less stress
Psychosocial Health: Quality of Individual's Relationships	Baseline, 8 weeks	PROMIS Satisfaction with Social Roles and Activities (SSRA)-Short Form 4a (PROMIS-SSRA), raw scores range from 4 to 20, T scores range from 27.9 to 63.8, higher score is more satisfaction
Psychosocial Health: Satisfaction With Social Activities	Baseline, 8 weeks	PROMIS Short Form v1.0- Satisfaction with Participation in Discretionary Social Activities- Short Form 7a (PROMIS SPDSA) raw scores range from 7 to 35, T scores range from 28.7 to 67.3, higher score is more satisfaction
Psychosocial Health: Companionship	Baseline, 8 weeks	PROMIS Companionship - Short Form 4a (PROMIS-C) raw scores range from 4 to 20, T scores range from 25.2 to 65.3, higher score is more companionship
Psychosocial Health: Anxiety	baseline, 8 weeks	PROMIS Anxiety Short-Form 8a (PROMIS-A) raw scores range from 8 to 40, T scores range from 0-100, higher score is more anxiety
Stress Marker: Perceived Stress	Baseline, 8 weeks	Patient Reported Outcomes Measurement Information System (PROMIS) Perceived Stress; PROMIS PS, score range 10 to 50, T scores range from 22.7 to 87.1, higher is more stress perceived
Psychosocial Health: Positive Affect	Baseline, 8 weeks	PROMIS Positive Affect Short Form 15 (PA 152), raw scores range from 15 to 75 they are converted to T scores range of 14.4 to 69.9 with a mean of 50 and SD or 10, higher is greater positive affect
Psychosocial Health: Health Related Quality of Life	Baseline, 8 weeks	Veterans RAND 12 Item Health Survey (VR-12); physical health and mental health subscales; scales are calculated with an algorithm with a mean of 50 as the 50th percentile of the U.S. population; higher score is better (higher quality of life).
Psychosocial Health:Depression	baseline, 8 weeks	PROMIS Depression Short-Form 8a (PROMIS-D), raw scores range from 8 to 40, T scores range from 0-100, higher score is more depression
Psychosocial Health: Suicidal Ideation	Baseline, 8 weeks	Beck Scale for Suicide Ideation (BSSI), raw scores range from 0 to 38, higher score is greater suicidal ideation
Stress Biomarker Markers:Cortisol	Baseline, 8 weeks	salivary cortisol ug/dL; higher is more stress