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Completed

NCT Number: NCT03777020

Service Dog Training Program for Military Veterans With PTSD

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.

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Key information

Conditions

Post Traumatic Stress Disorder Behavior Human-Animal Interaction Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Warrior Canine Connections

Boyds, Maryland, 20841, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Accepted into the Warrior Canine Connection Service Dog Training Program. Their inclusion criteria are:
  • military veteran;
  • diagnosis of PTSD;
  • able to give informed consent; and
  • able to understand English; And
  • Military Veteran

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

.

Treatment and study plan

Service Dog Training Program

Behavioral

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.

Dog Training Education

Other

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.

Primary outcomes

  1. Post Traumatic Stress Symptom Severity

    Time frame: Baseline, 8 weeks

    Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)

Secondary outcomes

  1. Stress Biomarker Markers:Cortisol

    Time frame: Baseline, 8 weeks

    salivary cortisol ug/dL; higher is more stress

  2. Stress Biomarkers: Alpha Amylase

    Time frame: Baseline, 8 weeks

    salivary alpha amylase U/mL; higher is more stress

  3. Stress Biomarkers: IgA

    Time frame: Baseline, 8 weeks

    salivary immunoglobulin A μg/mL; higher is less stress

  4. Stress Biomarkers: HRV

    Time frame: 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

  5. Stress Marker: Perceived Stress

    Time frame: 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

  6. Psychosocial Health: Positive Affect

    Time frame: 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

  7. Psychosocial Health: Health Related Quality of Life

    Time frame: 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).

  8. Psychosocial Health: Resilience

    Time frame: Baseline, 8 weeks

    Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient

  9. Psychosocial Health: Relationship With Friends and Family

    Time frame: 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

  10. Psychosocial Health: Quality of Individual's Relationships

    Time frame: 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

  11. Psychosocial Health: Satisfaction With Social Activities

    Time frame: 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

  12. Psychosocial Health: Companionship

    Time frame: 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

  13. Psychosocial Health:Depression

    Time frame: 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

  14. Psychosocial Health: Anxiety

    Time frame: 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

  15. Psychosocial Health: Suicidal Ideation

    Time frame: Baseline, 8 weeks

    Beck Scale for Suicide Ideation (BSSI), raw scores range from 0 to 38, higher score is greater suicidal ideation

Other outcomes

  1. Cellular Aging

    Time frame: Baseline, 8 weeks

    total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2018
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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