- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03068325
Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD (TF-EAT)
April 7, 2025 updated by: Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
This study seeks to examine feasibility, acceptability, safety, and preliminary efficacy of Equine-Assisted Therapy for veterans with posttraumatic stress disorder (EAT-PTSD).
While several well-studied, validated treatments for PTSD exist, some individuals find these treatments ill-suited, ineffective, or undesirable.
EAT is an alternative therapy widely used by organizations, such as PATH International Equine Services, that endorse its effectiveness for treating a variety of mental health issues.
These claims have drawn criticism because the published research contains glaring methodological flaws, making it difficult to assess how effective these therapies actually are (Anestis et al., 2014).
Equine-assisted therapies present a unique treatment modality that might effectively treat PTSD, particularly for individuals who have difficulty with other treatment modalities.
In EAT, a psychotherapist and equine specialist work together to help the patients negotiate interactions with a horse using structured interventions or activities.
Study Overview
Detailed Description
In this pilot study the investigators will develop the EAT intervention and determine whether research methods (evaluation interviews, assessment measures, videotaping procedures) are acceptable to participants.
Specifically, the investigators will focus on issues such as session length, appropriateness of the "content" for treatment of PTSD, ordering of session content, adherence to the manual of the equine therapeutic team (based on observations made during supervision and feedback from the consultants), and will detail logistics of data collection and how best to record the sessions (camera angles, etc.).
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Between the ages of 18 and 70
- Current DSM-5 diagnosis of PTSD as determined by a) full criteria met on CAPS, and b) clinical assessment
- Able to give consent, fluent in English
Exclusion Criteria:
- History of psychiatric diagnosis of psychotic disorder, unstable bipolar disorder
- Elevated depression of clinical concern and/or score of >25 on the Hamilton Rating Scale for Depression
- At elevated risk for suicide based on history and current mental state
- History of substance/alcohol use disorder at severe level within the past six months, and current diagnosis of substance/alcohol use disorder at a moderate level within past two months
- Fear of horses or other large animals
- Orthopedic or other physical conditions and/or limitations that prevent people from walking unassisted and/or walking freely in the ring.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EAT-PTSD
Manualized Equine-Assisted Treatment for PTSD (EAT-PTSD) seeks to increase affective awareness of self and others, improve communication, help regulate emotional response, improve critical thinking/problem solving, and increase self-confidence/self-efficacy while engaging with the horses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Clinician-Administered PTSD Scale at 8 Weeks
Time Frame: 8 weeks
|
Change in symptoms of PTSD as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, severity rating ranging from 0-80 with higher scores indicating more severe PTSD) in a clinical interview
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yuval Neria, PhD, Columbia University Irving Medical Center, New York State Psychiatric Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fisher PW, Lazarov A, Lowell A, Arnon S, Turner JB, Bergman M, Ryba M, Such S, Marohasy C, Zhu X, Suarez-Jimenez B, Markowitz JC, Neria Y. Equine-Assisted Therapy for Posttraumatic Stress Disorder Among Military Veterans: An Open Trial. J Clin Psychiatry. 2021 Aug 31;82(5):21m14005. doi: 10.4088/JCP.21m14005.
- Zhu X, Suarez-Jimenez B, Zilcha-Mano S, Lazarov A, Arnon S, Lowell AL, Bergman M, Ryba M, Hamilton AJ, Hamilton JF, Turner JB, Markowitz JC, Fisher PW, Neria Y. Neural changes following equine-assisted therapy for posttraumatic stress disorder: A longitudinal multimodal imaging study. Hum Brain Mapp. 2021 Apr 15;42(6):1930-1939. doi: 10.1002/hbm.25360. Epub 2021 Feb 5.
- Arnon S, Fisher PW, Pickover A, Lowell A, Turner JB, Hilburn A, Jacob-McVey J, Malajian BE, Farber DG, Hamilton JF, Hamilton A, Markowitz JC, Neria Y. Equine-Assisted Therapy for Veterans with PTSD: Manual Development and Preliminary Findings. Mil Med. 2020 Jun 8;185(5-6):e557-e564. doi: 10.1093/milmed/usz444.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
February 26, 2017
First Submitted That Met QC Criteria
February 26, 2017
First Posted (Actual)
March 1, 2017
Study Record Updates
Last Update Posted (Actual)
April 8, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB # 7232
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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