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Service Dog Training Program for Military Veterans With PTSD

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Service Dog Training Program
Dog Training Education
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring human-animal interaction, service dog, stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

.

Sites / Locations

  • Warrior Canine Connections

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Service Dog Training Program (SDTP)

Dog Training Education

Arm Description

Veterans randomized to the SDTP will be paired with an experienced Warrior Canine Connection (WCC) Mission Based Trauma Recovery (MBTR)-Trainer (MBRT-T) and a service dog (SD). One hour training modules will be scheduled once a week for 8 weeks. Participants will come to WCC for all the weekly training modules. Participants will be paired with the same SD for the duration of the SDTP unless an unforeseen circumstance arises and the SD needs to be removed from the SDTP. The MBTR-T will deliver the prescribed SDTP modules created by WCC. Each session will be fully supervised by a WCC MBTR-T to address any concerns or safety issues that may arise.

Veterans randomized to Dog Training Education will participate in one hour online SD training modules (https://e-trainingfordogs.com) scheduled once a week for 8 weeks. The online training modules are delivered by experienced SD trainers and will employ parallel content to the WCC SDTP. Participants will come to the WCC site for all the weekly online training modules. Members of the WLCI group will have education about dog training, but NO interaction with a SD. The online training modules for the DTE group are intended to keep the veterans who are not immediately assigned to the SDTP engaged in the study. They will participate in the SDTP after conclusion of participation in the 8 week study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stress biomarker markers:cortisol
salivary cortisol ug/dL; higher is more stress
Stress biomarkers: alpha amylase
salivary alpha amylase U/mL; higher is more stress
Stress biomarkers: IgA
salivary immunoglobulin A μg/mL; higher is less stress
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
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
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
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).
Psychosocial Health: Resilience
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
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
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
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
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
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
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
Psychosocial Health: Suicidal Ideation
Beck Scale for Suicide Ideation (BSSI), raw scores range from 0 to 38, higher score is greater suicidal ideation

Full Information

First Posted
December 10, 2018
Last Updated
May 3, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03777020
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
human-animal interaction, service dog, stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Service Dog Training Program (SDTP)
Arm Type
Experimental
Arm Description
Veterans randomized to the SDTP will be paired with an experienced Warrior Canine Connection (WCC) Mission Based Trauma Recovery (MBTR)-Trainer (MBRT-T) and a service dog (SD). One hour training modules will be scheduled once a week for 8 weeks. Participants will come to WCC for all the weekly training modules. Participants will be paired with the same SD for the duration of the SDTP unless an unforeseen circumstance arises and the SD needs to be removed from the SDTP. The MBTR-T will deliver the prescribed SDTP modules created by WCC. Each session will be fully supervised by a WCC MBTR-T to address any concerns or safety issues that may arise.
Arm Title
Dog Training Education
Arm Type
Other
Arm Description
Veterans randomized to Dog Training Education will participate in one hour online SD training modules (https://e-trainingfordogs.com) scheduled once a week for 8 weeks. The online training modules are delivered by experienced SD trainers and will employ parallel content to the WCC SDTP. Participants will come to the WCC site for all the weekly online training modules. Members of the WLCI group will have education about dog training, but NO interaction with a SD. The online training modules for the DTE group are intended to keep the veterans who are not immediately assigned to the SDTP engaged in the study. They will participate in the SDTP after conclusion of participation in the 8 week study.
Intervention Type
Behavioral
Intervention Name(s)
Service Dog Training Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dog Training Education
Intervention Description
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 Outcome Measure Information:
Title
Post traumatic stress symptom severity
Description
Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Stress biomarker markers:cortisol
Description
salivary cortisol ug/dL; higher is more stress
Time Frame
8 weeks
Title
Stress biomarkers: alpha amylase
Description
salivary alpha amylase U/mL; higher is more stress
Time Frame
8 weeks
Title
Stress biomarkers: IgA
Description
salivary immunoglobulin A μg/mL; higher is less stress
Time Frame
8 weeks
Title
Stress biomarkers: HRV
Description
Heart rate variability Polar H7 heart rate sensor worn around the chest and matching Polar V800 GPS Sports Watch, higher is better
Time Frame
8 weeks
Title
Stress marker: Perceived Stress
Description
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
Time Frame
8 weeks
Title
Psychosocial Health: Positive Affect
Description
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
Time Frame
8 weeks
Title
Psychosocial Health: Health Related Quality of Life
Description
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).
Time Frame
8 weeks
Title
Psychosocial Health: Resilience
Description
Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient
Time Frame
8 weeks
Title
Psychosocial Health: Relationship with Friends and Family
Description
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
Time Frame
8 weeks
Title
Psychosocial Health: Quality of Individual's Relationships
Description
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
Time Frame
8 weeks
Title
Psychosocial Health: Satisfaction with Social Activities
Description
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
Time Frame
8 weeks
Title
Psychosocial Health: Companionship
Description
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
Time Frame
8 weeks
Title
Psychosocial Health:Depression
Description
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
Time Frame
8 weeks
Title
Psychosocial Health: Anxiety
Description
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
Time Frame
8 weeks
Title
Psychosocial Health: Suicidal Ideation
Description
Beck Scale for Suicide Ideation (BSSI), raw scores range from 0 to 38, higher score is greater suicidal ideation
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Cellular Aging
Description
total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Friedmann, PhD
Organizational Affiliation
University of Maryland, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warrior Canine Connections
City
Boyds
State/Province
Maryland
ZIP/Postal Code
20841
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Service Dog Training Program for Military Veterans With PTSD

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