Posttraumatic Stress DisorderTHRICFNCT02893202
Equine Assisted Activities on PTSD, Quality of Life and Functioning in Veterans With PTSD: An ICF Approach (THRICF)
A study testing Therapeutic Horseback riding in people with Posttraumatic Stress Disorder, run by Baylor University.
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]. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Therapeutic Horseback riding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- had a diagnosis of bipolar, schizophrenia, or presence of psychosis
- active substance dependence within the last three months
- significant cognitive impairment
About this study
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
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Therapeutic Horseback riding
- Keywords
- PTSD, Equine assisted activities, quality of life
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Horseback ridingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ride On Center for Kids (ROCK) facility | Experimental | 8-week therapeutic horseback riding Receives: Other: Therapeutic Horseback riding |
| Triple H Equitherapy Facility | Experimental | 8-week therapeutic horseback riding Receives: Other: Therapeutic Horseback riding |
| Rainer Therapeutic Riding facility | Experimental | 8-week therapeutic horseback riding Receives: Other: Therapeutic Horseback riding |
| REACH Therapeutic Riding facility | Experimental | 8-week therapeutic horseback riding Receives: Other: Therapeutic Horseback riding |
| Courtney Cares Riding facility | Experimental | 8-week therapeutic horseback riding Receives: Other: Therapeutic Horseback riding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms
PCL-5 to measure PTSD symptoms at each time point
Measured: baseline, 4 weeks, 8 weeks, and 2 month post intervention
Secondary outcomes (4)
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.
Measured: 8 weeks
Change in Disability and Functioning
WHODAS 2 was used to measure level of functioning at each time point
Measured: baseline, 4 weeks, 8 weeks, and 2 month post intervention
Change in Quality of life
SF36v2 was used to measure quality of life at each time point
Measured: baseline, 4 weeks, 8 weeks, and 2 month post intervention
Change in Depression symptoms
Major Depression Inventory was used to measure depression symptoms at each time point
Measured: baseline, 4 weeks, 8 weeks, and 2 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startAug 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- Horses and Humans Research Foundation
- Responsible party
- Sponsor
- Investigators
- Beth A Lanning, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893202
- Sponsor's protocol ID
- EAAVeterans
- Acronym
- THRICF
- Status last verified
- Jul 2023
- First submitted
- 30 Aug 2016
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 21076562Ware, 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.
PubMed 12959332
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02893202
- Acronym / sponsor ID
- THRICF / EAAVeterans
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Equine assisted activities, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- Horses and Humans Research Foundation
- Study start
- Aug 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ride On Center for Kids (ROCK) facility | Experimental | Other: Therapeutic Horseback riding8-week therapeutic horseback riding |
| Triple H Equitherapy Facility | Experimental | Other: Therapeutic Horseback riding8-week therapeutic horseback riding |
| Rainer Therapeutic Riding facility | Experimental | Other: Therapeutic Horseback riding8-week therapeutic horseback riding |
| REACH Therapeutic Riding facility | Experimental | Other: Therapeutic Horseback riding8-week therapeutic horseback riding |
| Courtney Cares Riding facility | Experimental | Other: Therapeutic Horseback riding8-week therapeutic horseback riding |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- had a diagnosis of bipolar, schizophrenia, or presence of psychosis
- active substance dependence within the last three months
- significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Horseback ridingAn 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. | Other | Courtney Cares Riding facility, REACH Therapeutic Riding facility, Rainer Therapeutic Riding facility, Ride On Center for Kids (ROCK) facility, Triple H Equitherapy Facility |
Primary outcome
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
4 secondary outcomes
Change in behavior by participating in the program assessed with a semi-structured questionnaire
Time frame: 8 weeks
Change in Disability and Functioning
Time frame: 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
Change in Depression symptoms
Time frame: baseline, 4 weeks, 8 weeks, and 2 month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 21076562Ustun 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.
- BackgroundWare, J. E., Kosinski, M., & Keller, S. D. (1994). SF-36 Physical and Mental Component Summary Measures: A User's Manual Boston: The Health Institute.
- Background: PubMed 12959332Schneidert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth A Lanning, PhD principal investigator
Baylor University
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Horseback riding in people with Posttraumatic Stress Disorder, run by Baylor University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms (time frame: baseline, 4 weeks, 8 weeks, and 2 month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893202, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.