- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02893202
Equine Assisted Activities on PTSD, Quality of Life and Functioning in Veterans With PTSD: An ICF Approach (THRICF) (THRICF)
Examination of the Effects of Equine Assisted Activities [EAA] on Symptoms, Quality of Life and Functioning in Veterans With PTSD: An International Classification of Functioning, Disability and Health [ICF] Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research design was a quasi-experimental trial using mixed methods. Veterans recruited to a treatment group or a waitlist control group. Both qualitative and quantitative data was collected to assess changes. Qualitative data was collected post-intervention and quantitative data was collected at baseline, mid-intervention, post-intervention and 2-month follow-up.
A total of 125 veterans were recruited for the study. Eighty-nine met inclusion criteria.
Five therapeutic riding facilities will be utilized for this study: Ride On Center for Kids (R.O.C.K.), Georgetown, Texas; Riding Equines to Achieve Confidence and Health (R.E.A.C.H.), McGregor, Texas; Texas A&M Systems Courtney Grimshaw Fowler Equine Therapeutic Riding Center (Courtney Cares), College Station, Texas; Triple H, Cripple Creek, Texas, and Rainier Therapeutic Riding, Yelm, Washington. Two of the sites (R.O.C.K. and Rainier TR) are Professional Association of Therapeutic Horsemanship International [PATHIntl] premier accredited facilities, one (R.E.A.C.H.) is reaching premier status, and one (Courtney Cares) is under the direction of the research director at R.O.C.K. All four sites have existing Professional Association of Therapeutic Horsemanship [PATH] Equine for Service Members programs and the staff is experienced with the veteran population. Five sites were needed to ensure adequate sample size for the study.
EAA Protocol
The eight week EAA program followed the same protocol at all five testing sites with riding instructors and staff using a standardized curriculum, Rainier Therapeutic Riding's Riding Through Recovery. Baseline assessments was conducted for all participants in both the EAA group and the wait-list group. The EAA program consisted of eight, 90 minute weekly lessons. The first few lessons focused on developing a relationship between the horse and the participant without riding. The last two lessons included riding instruction if the participant chooses to ride. The PTSD Checklist- Military [PCL-M] and PTSD Checklist-5 [PCL-5] were administered pre and post as well as 2 months following the program. The Short Form Health Survey [SF-36v2], World Health Organization Disability Assessment Schedule 2.0 [WHODAS-2.0] and the Major Depression Inventory [MDI] were completed before beginning the program, at four weeks (mid-treatment), post-treatment and 2 months follow-up. Open-ended questions were completed post-treatment. The wait-list group participated in treatment as usual (TAU) and was assessed using the same instruments and time sequence with the exception of the post-treatment open-ended questions and the 2 month follow-up. After the first eight weeks, the wait-list group participated in the EAA intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- participated in any of the three Iraq and Afghanistan war missions Operation Enduring Freedom, [OEF], Operation Iraqi Freedom,[OIF], Operation New Dawn, [OND]
- diagnosed with PTSD or exhibiting PTSD symptoms and confirmed using PCL-M or PCL-5 provisional diagnosis
- not participated in equine assisted activities and therapies six months prior to the start of the study
Exclusion Criteria:
- had a diagnosis of bipolar, schizophrenia, or presence of psychosis
- active substance dependence within the last three months
- significant cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ride On Center for Kids (ROCK) facility
8-week therapeutic horseback riding
|
An 8-week equine-assisted program designed to especially for veterans.
The curriculum consists of eight 90-minute sessions designed to teach basic horse care and riding skills along with communication skills.
|
Experimental: Triple H Equitherapy Facility
8-week therapeutic horseback riding
|
An 8-week equine-assisted program designed to especially for veterans.
The curriculum consists of eight 90-minute sessions designed to teach basic horse care and riding skills along with communication skills.
|
Experimental: Rainer Therapeutic Riding facility
8-week therapeutic horseback riding
|
An 8-week equine-assisted program designed to especially for veterans.
The curriculum consists of eight 90-minute sessions designed to teach basic horse care and riding skills along with communication skills.
|
Experimental: REACH Therapeutic Riding facility
8-week therapeutic horseback riding
|
An 8-week equine-assisted program designed to especially for veterans.
The curriculum consists of eight 90-minute sessions designed to teach basic horse care and riding skills along with communication skills.
|
Experimental: Courtney Cares Riding facility
8-week therapeutic horseback riding
|
An 8-week equine-assisted program designed to especially for veterans.
The curriculum consists of eight 90-minute sessions designed to teach basic horse care and riding skills along with communication skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PTSD symptoms
Time Frame: baseline, 4 weeks, 8 weeks, and 2 month post intervention
|
PCL-5 to measure PTSD symptoms at each time point
|
baseline, 4 weeks, 8 weeks, and 2 month post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in behavior by participating in the program assessed with a semi-structured questionnaire
Time Frame: 8 weeks
|
semi-structured questions designed to elicit responses about changes in behavior by participating in the program.
|
8 weeks
|
Change in Disability and Functioning
Time Frame: baseline, 4 weeks, 8 weeks, and 2 month post intervention
|
WHODAS 2 was used to measure level of functioning at each time point
|
baseline, 4 weeks, 8 weeks, and 2 month post intervention
|
Change in Quality of life
Time Frame: baseline, 4 weeks, 8 weeks, and 2 month post intervention
|
SF36v2 was used to measure quality of life at each time point
|
baseline, 4 weeks, 8 weeks, and 2 month post intervention
|
Change in Depression symptoms
Time Frame: baseline, 4 weeks, 8 weeks, and 2 month post intervention
|
Major Depression Inventory was used to measure depression symptoms at each time point
|
baseline, 4 weeks, 8 weeks, and 2 month post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Beth A Lanning, PhD, Baylor University
Publications and helpful links
General Publications
- Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.
- Ware, J. E., Kosinski, M., & Keller, S. D. (1994). SF-36 Physical and Mental Component Summary Measures: A User's Manual Boston: The Health Institute.
- Schneidert M, Hurst R, Miller J, Ustun B. The role of environment in the International Classification of Functioning, Disability and Health (ICF). Disabil Rehabil. 2003 Jun 3-17;25(11-12):588-95. doi: 10.1080/0963828031000137090.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EAAVeterans
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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