search
Back to results

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
Baylor University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 30, 2016
    Last Updated
    July 28, 2023
    Sponsor
    Baylor University
    Collaborators
    Horses and Humans Research Foundation
    search

    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

    Learn more about this trial

    Equine Assisted Activities on PTSD, Quality of Life and Functioning in Veterans With PTSD: An ICF Approach (THRICF)

    We'll reach out to this number within 24 hrs