Clinical trial NCT03068325: Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD
Official title: Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2017-03-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.).

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.

Primary outcomes:
measure: Change From Baseline in Clinician-Administered PTSD Scale at 8 Weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University Irving Medical Center, New York State Psychiatric Institute
name: Yuval Neria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.