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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03068325
Other study ID # IRB # 7232
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date May 2020

Study information

Verified date September 2019
Source Research Foundation for Mental Hygiene, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 71
Est. completion date May 2020
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
TF-EAT


Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (2)

Lead Sponsor Collaborator
Research Foundation for Mental Hygiene, Inc. Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Clinician-Administered PTSD Scale at 8 weeks 8 weeks
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