Post Traumatic Stress Disorder
Conditions
Keywords
human-animal interaction, service dog, stress
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.
Interventions
BEHAVIORALService 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.
OTHERDog 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.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Stress Biomarker Markers:Cortisol | Baseline, 8 weeks | salivary cortisol ug/dL; higher is more stress |
| Stress Biomarkers: Alpha Amylase | Baseline, 8 weeks | salivary alpha amylase U/mL; higher is more stress |
| Stress Biomarkers: IgA | Baseline, 8 weeks | salivary immunoglobulin A μg/mL; higher is less 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 |
| 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: 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 |
| 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: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: 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 |
| 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 |
| Psychosocial Health: Resilience | Baseline, 8 weeks | Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cellular Aging | Baseline, 8 weeks | total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Service Dog Training Program (SDTP) 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.
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. | 30 |
| Dog Training Education 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.
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. | 29 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No longer met inclusion criteria at initial visit | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Service Dog Training Program (SDTP) | Dog Training Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 26 Participants | 54 Participants |
| Age, Continuous | 47.4 years STANDARD_DEVIATION 10.5 | 47.3 years STANDARD_DEVIATION 12.4 | 47.4 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 26 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 8 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 19 Participants | 39 Participants |
| Region of Enrollment United States | 30 participants | 29 participants | 59 participants |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 17 Participants | 14 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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)
Time frame: Baseline, 8 weeks
Population: Veterans with PTSD
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Service Dog Training Program (SDTP) | Post Traumatic Stress Symptom Severity | 8 weeks | 35.1 score on a scale | Standard Error 3.1 |
| Service Dog Training Program (SDTP) | Post Traumatic Stress Symptom Severity | Baseline | 43.7 score on a scale | Standard Error 3.1 |
| Dog Training Education | Post Traumatic Stress Symptom Severity | 8 weeks | 31.6 score on a scale | Standard Error 3.2 |
| Dog Training Education | Post Traumatic Stress Symptom Severity | Baseline | 38.9 score on a scale | Standard Error 3.2 |
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
Time frame: baseline, 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
Time frame: Baseline, 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
Time frame: baseline, 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).
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 8 weeks
Secondary
Psychosocial Health: Resilience
Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 8 weeks
Secondary
Stress Biomarker Markers:Cortisol
salivary cortisol ug/dL; higher is more stress
Time frame: Baseline, 8 weeks
Secondary
Stress Biomarkers: Alpha Amylase
salivary alpha amylase U/mL; higher is more stress
Time frame: Baseline, 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
Time frame: baseline, 8 weeks
Secondary
Stress Biomarkers: IgA
salivary immunoglobulin A μg/mL; higher is less stress
Time frame: Baseline, 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
Time frame: Baseline, 8 weeks
Other Pre-specified
Cellular Aging
total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging
Time frame: Baseline, 8 weeks