Service Dog Training Program for Military Veterans With PTSD

Post Traumatic Stress Disorder Clinical Trial

Official title:

Evaluating the Efficacy of a Service Dog Training Program for Military Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777020
• Other study ID #: HP-00083872
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Service Dog Training Program
Participate in 8 weekly dog training sessions using a positive reinforcement method and curriculum under the direct supervision of trainer at the Warrior Canine Connection facility in Boyds (Montgomery County) MD.

Other:
• Dog Training Education
Learn about training dogs by watching 8 weekly dog training online modules programs at the Warrior Canine Connection facility in Boyds (Montgomery County) MD. After completing this education the participants will participate in the service dog training program.

Locations

Country	Name	City	State
United States	Warrior Canine Connections	Boyds	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cellular Aging	total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging	8 weeks
Primary	Post traumatic stress symptom severity	Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)	8 weeks
Secondary	Stress biomarker markers:cortisol	salivary cortisol ug/dL; higher is more stress	8 weeks
Secondary	Stress biomarkers: alpha amylase	salivary alpha amylase U/mL; higher is more stress	8 weeks
Secondary	Stress biomarkers: IgA	salivary immunoglobulin A µg/mL; higher is less stress	8 weeks
Secondary	Stress biomarkers: HRV	Heart rate variability Polar H7 heart rate sensor worn around the chest and matching Polar V800 GPS Sports Watch, higher is better	8 weeks
Secondary	Stress marker: Perceived Stress	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	8 weeks
Secondary	Psychosocial Health: Positive Affect	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	8 weeks
Secondary	Psychosocial Health: Health Related Quality of Life	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).	8 weeks
Secondary	Psychosocial Health: Resilience	Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient	8 weeks
Secondary	Psychosocial Health: Relationship with Friends and Family	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	8 weeks
Secondary	Psychosocial Health: Quality of Individual's Relationships	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	8 weeks
Secondary	Psychosocial Health: Satisfaction with Social Activities	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	8 weeks
Secondary	Psychosocial Health: Companionship	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	8 weeks
Secondary	Psychosocial Health:Depression	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	8 weeks
Secondary	Psychosocial Health: Anxiety	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	8 weeks
Secondary	Psychosocial Health: Suicidal Ideation	Beck Scale for Suicide Ideation (BSSI), raw scores range from 0 to 38, higher score is greater suicidal ideation	8 weeks