Equine Assisted Psychotherapy for PTSD

March 5, 2018 updated by: University of New Mexico

The purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD symptoms in veterans with PTSD as compared with existing care.

The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms following participation in a 6-week Equine Assisted Psychotherapy program.

Study Overview

Status

Completed

Detailed Description

This study will employ a randomized, parallel group design with delayed intervention in the control group. Eligible participants will be randomly assigned using a random number generator. The PTSD Checklist (PCL) - Military (measuring PTSD symptoms) will be administered to each participant at week 0 and week 6. Permissions have been obtained for the use of the survey.

Surveys will be identified by randomized number only, to maintain confidentiality. Participants will be assigned a unique identifier. A list of participant's initials and their random assigned numbers will be kept in a locked secure file by the investigator. In this way the participants confidentially will be protected.

The participants assigned to the intervention group will complete the Equine Assisted Psychotherapy (EAP) program that will be performed at an Equine Assisted Growth and Learning Association (EAGALA) certified facility. The participants will be going through a 6 week program. The researcher will not be conducting the therapy. An EAGALA certified and licensed Occupational Therapist will be running the therapy as well as a professional Horse Handler for safety. In the event that a participant is in need of additional therapy as a result of this research, a psychotherapist will be on call. Participation will not include riding the horses. "The basis of the EAGALA Model is a belief that all clients have the best solutions for themselves when given the opportunity to discover them. Rather than instructing or directing solutions, [the instructor] allow [their] clients to experiment, problem-solve, take risks, employ creativity, and find their own solutions that work best for them. No horseback riding is involved. Instead, effective and deliberate techniques are utilized where the horses are metaphors in specific ground-based experiences." (http://www.eagala.org/Information/What_Is_EAGALA_Model) All horse based activities involve inherent risk. The facility and the horses that the participants will be using are used daily for Hippotherapy involving disabled individuals. All safety procedures and precautions outlined by the EAGALA certifications and the therapy facility will be strictly maintained. The participants may decline to do any of the therapy activities and or survey questions at any time. If the certified therapist senses a problem, they will stop the therapy and consult with a psychotherapist.

The participants assigned to the control group will have no intervention related to the research but may continue any preexisting therapy. They will be asked to not initiate any new therapy programs. The participants will be however given the option of delayed EAP after the completion of the 6 week program.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants will include war veterans with post-traumatic stress disorder, who have a PCL-M symptom score of ≥ 29 with an age between 18 and 75.

Exclusion Criteria:

  • Adults unable to consent, individuals aged < 18 years, individuals receiving antipsychotic medication, individuals receiving glucocorticoid therapy, and/or pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Equine Assisted Psychotherapy
6 week Equine Assisted Psychotherapy program
Therapist will use Equine Assisted Growth and Learning Association (EAGALA) modeled Equine Assisted Psychotherapy.
Other Names:
  • Equine Assisted Therapy
No Intervention: Control
Standard of Care, Existing PTSD therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 17-item PCL-Military (PTSD Symptoms)
Time Frame: Baseline and 6 weeks
A validated and widely used survey instrument to assess PTSD symptoms for the purposes of diagnosis, clinical assessment, and scientific inquiry. Scores range from 17 to 85 in severity, with anything over 29 as having PTSD.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark R Burge, MD, UNM Clinical Translational Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will be provided in Lobo vault after finalization of the study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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