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Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD (TF-EAT)

Primary Purpose

Posttraumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TF-EAT
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

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

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.

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TF-EAT

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in Clinician-Administered PTSD Scale at 8 weeks

Secondary Outcome Measures

Full Information

First Posted
February 26, 2017
Last Updated
September 19, 2019
Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03068325
Brief Title
Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD
Acronym
TF-EAT
Official Title
Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
Columbia University

4. Oversight

5. Study Description

Brief Summary
This study seeks to examine feasibility, acceptability, safety, and preliminary efficacy of trauma-focused Equine-Assisted Therapy (EAT) for veterans with posttraumatic stress disorder (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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TF-EAT
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
TF-EAT
Primary Outcome Measure Information:
Title
Change from Baseline in Clinician-Administered PTSD Scale at 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34464523
Citation
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.
Results Reference
derived
PubMed Identifier
33547694
Citation
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.
Results Reference
derived
PubMed Identifier
32034416
Citation
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.
Results Reference
derived

Learn more about this trial

Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD

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