NCT03068325

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

April 8, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

3.2 years

First QC Date

February 26, 2017

Results QC Date

February 15, 2022

Last Update Submit

April 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    8 weeks

Study Arms (1)

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.

Other: EAT-PTSD

Interventions

EAT-PTSD

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Yuval Neria
Organization
New York State Psychiatric Institute

Study Officials

  • Yuval Neria, PhD

    Columbia University Irving Medical Center, New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Psychology

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 1, 2017

Study Start

April 1, 2016

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

April 8, 2025

Results First Posted

April 8, 2025

Record last verified: 2025-04

Locations