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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893202
Other study ID # EAAVeterans
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2013
Est. completion date June 2016

Study information

Verified date July 2023
Source Baylor University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the research project was to assess changes in Posttraumatic stress disorder [PTSD] symptoms, quality of life and participation of combat veteran who participate in equine assisted activities [EAA]. The study used a mixed-methods, waitlist-controlled, repeated measures trial of a standardized 8-week therapeutic riding intervention for combat veterans with PTSD. Behavioral changes were assessed four times during the study. Veterans meeting inclusion criteria were selected to participate in either the intervention group or the control/waitlist group.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 25 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Baylor University Horses and Humans Research Foundation

References & Publications (3)

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. — View Citation

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Change in PTSD symptoms PCL-5 to measure PTSD symptoms at each time point baseline, 4 weeks, 8 weeks, and 2 month post intervention
Secondary Change in behavior by participating in the program assessed with a semi-structured questionnaire semi-structured questions designed to elicit responses about changes in behavior by participating in the program. 8 weeks
Secondary Change in Disability and Functioning WHODAS 2 was used to measure level of functioning at each time point baseline, 4 weeks, 8 weeks, and 2 month post intervention
Secondary Change in Quality of life SF36v2 was used to measure quality of life at each time point baseline, 4 weeks, 8 weeks, and 2 month post intervention
Secondary Change in Depression symptoms Major Depression Inventory was used to measure depression symptoms at each time point baseline, 4 weeks, 8 weeks, and 2 month post intervention
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