Clinical trial NCT04832815: Equine Human Interaction With Veterans
Official title: Equine Human Interaction With Veterans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Equine
PTSD
Lead sponsor: VA Salt Lake City Health Care System
Sponsor class: FED
Collaborators: name: Utah State University
First posted: 2021-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has two components. The first component (Aim 1) is a randomized trial of a novel equine therapy intervention that was developed for research purposes. The second component (Aim 2) is an evaluation of outcomes from Veterans participating in an adaptive horsemanship program that is not conducted for research purposes.


Eligibility criteria: Inclusion Criteria:

For Aim 1:

* Currently enrolled for services at the VA Salt Lake City Health Care System
* At least one mental health service encounter within the preceding 12 months
* Diagnosed with PTSD by a clinician within the preceding 24 months
* Have a doctor release to participate in equine activities

For Aim 2:

* Currently enrolled for services at the VA Salt Lake City Health Care System
* Have a doctor release to participate in equine activities

Exclusion Criteria:

* Pregnancy
* Diagnoses of a psychotic spectrum illness and/or cognitive impairment
* Physical disability that would prevent horseback riding
* Weight \>= 250 lbs.
* Potentially the severity of and psychological and/or behavioral symptoms will be considered

Primary outcomes:
measure: Mean Difference in Acceptance and Action Questionnaire-II (AAQII) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program
timeFrame: through study completion, an average of 2 years
measure: Heart Rate (HR) Indices
timeFrame: through study completion, an average of 2 years
measure: Mean Difference in Positive and Negative Affect Scale (PANAS) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program
timeFrame: through study completion, an average of 2 years
measure: Mean Difference in Physical Activity Enjoyment Scale (PACES) for Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program
timeFrame: through study completion, an average of 2 years
measure: Mean Difference in Posttraumatic Stress Disorder Checklist (PCL) for Equine Therapy + TAU cohort compared to the TAU only cohort
timeFrame: through study completion, an average of 2 years
measure: Mean Difference in Beck Depression Inventory (BDI) for Equine Therapy + TAU cohort compared to the TAU only cohort
timeFrame: through study completion, an average of 2 years
measure: Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort
timeFrame: through study completion, an average of 2 years
measure: Mean and Standard Deviation of Personal Satisfaction Program Survey for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort
timeFrame: through study completion, an average of 2 years
measure: Mean Difference in Toronto Mindfulness Scale (TMS) for Equine Therapy + TAU cohort
timeFrame: through study completion, an average of 2 years
measure: Mean Difference in Five Facet Mindfulness Questionnaire (FFMQ) for Horsemanship Skills Training Program.
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Mean and Standard Deviation of Demographic information including medical and psychiatric diagnoses
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System
state: Utah
Study officials:
affiliation: Salt Lake City Veterans' Administration Medical Center
name: William R Marchand, MD
role: PRINCIPAL_INVESTIGATOR
References: