Posttraumatic Stress DisorderTF-EATNCT03068325
Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD
A study testing EAT-PTSD in people with Posttraumatic Stress Disorder, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- EAT-PTSD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
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.
Read the 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.).
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- EAT-PTSD
- 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.
EAT-PTSDOther
| Study group | Role | What they receive |
|---|---|---|
| EAT-PTSD | Experimental | 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. Receives: Other: EAT-PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Clinician-Administered PTSD Scale at 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startApr 2016
- Primary completionJul 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Yuval Neria, PhD, Principal investigator, Columbia University Irving Medical Center, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068325
- Sponsor's protocol ID
- IRB # 7232
- Acronym
- TF-EAT
- Status last verified
- Apr 2025
- First submitted
- 26 Feb 2017
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 34464523Zhu 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.
PubMed 33547694Arnon 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.
PubMed 32034416
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT03068325
- Acronym / sponsor ID
- TF-EAT / IRB # 7232
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- Columbia University
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EAT-PTSD | Experimental | Other: EAT-PTSDManualized 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| EAT-PTSD | Other | EAT-PTSD |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34464523Fisher 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.
- Derived from this study: PubMed 33547694Zhu 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.
- Derived from this study: PubMed 32034416Arnon 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.
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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.
Yuval Neria, PhD principal investigator
Columbia University Irving Medical Center, New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EAT-PTSD in people with Posttraumatic Stress Disorder, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
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 6 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Clinician-Administered PTSD Scale at 8 Weeks (time frame: 8 weeks). 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 NCT03068325, 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 8 Apr 2025.