Equine Assisted Activities on PTSD, Quality of Life and Functioning in Veterans With PTSD: An ICF Approach (THRICF) (THRICF)
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic Horseback riding
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Equine assisted activities, quality of life
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Ride On Center for Kids (ROCK) facility
Triple H Equitherapy Facility
Rainer Therapeutic Riding facility
REACH Therapeutic Riding facility
Courtney Cares Riding facility
Arm Description
8-week therapeutic horseback riding
8-week therapeutic horseback riding
8-week therapeutic horseback riding
8-week therapeutic horseback riding
8-week therapeutic horseback riding
Outcomes
Primary Outcome Measures
Change in PTSD symptoms
PCL-5 to measure PTSD symptoms at each time point
Secondary Outcome Measures
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.
Change in Disability and Functioning
WHODAS 2 was used to measure level of functioning at each time point
Change in Quality of life
SF36v2 was used to measure quality of life at each time point
Change in Depression symptoms
Major Depression Inventory was used to measure depression symptoms at each time point
Full Information
NCT ID
NCT02893202
First Posted
August 30, 2016
Last Updated
July 28, 2023
Sponsor
Baylor University
Collaborators
Horses and Humans Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02893202
Brief Title
Equine Assisted Activities on PTSD, Quality of Life and Functioning in Veterans With PTSD: An ICF Approach (THRICF)
Acronym
THRICF
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor University
Collaborators
Horses and Humans Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, Equine assisted activities, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ride On Center for Kids (ROCK) facility
Arm Type
Experimental
Arm Description
8-week therapeutic horseback riding
Arm Title
Triple H Equitherapy Facility
Arm Type
Experimental
Arm Description
8-week therapeutic horseback riding
Arm Title
Rainer Therapeutic Riding facility
Arm Type
Experimental
Arm Description
8-week therapeutic horseback riding
Arm Title
REACH Therapeutic Riding facility
Arm Type
Experimental
Arm Description
8-week therapeutic horseback riding
Arm Title
Courtney Cares Riding facility
Arm Type
Experimental
Arm Description
8-week therapeutic horseback riding
Intervention Type
Other
Intervention Name(s)
Therapeutic Horseback riding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PTSD symptoms
Description
PCL-5 to measure PTSD symptoms at each time point
Time Frame
baseline, 4 weeks, 8 weeks, and 2 month post intervention
Secondary Outcome Measure Information:
Title
Change in behavior by participating in the program assessed with a semi-structured questionnaire
Description
semi-structured questions designed to elicit responses about changes in behavior by participating in the program.
Time Frame
8 weeks
Title
Change in Disability and Functioning
Description
WHODAS 2 was used to measure level of functioning at each time point
Time Frame
baseline, 4 weeks, 8 weeks, and 2 month post intervention
Title
Change in Quality of life
Description
SF36v2 was used to measure quality of life at each time point
Time Frame
baseline, 4 weeks, 8 weeks, and 2 month post intervention
Title
Change in Depression symptoms
Description
Major Depression Inventory was used to measure depression symptoms at each time point
Time Frame
baseline, 4 weeks, 8 weeks, and 2 month post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth A Lanning, PhD
Organizational Affiliation
Baylor University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21076562
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
12959332
Citation
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.
Results Reference
background
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Equine Assisted Activities on PTSD, Quality of Life and Functioning in Veterans With PTSD: An ICF Approach (THRICF)
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