Equine Assisted Psychotherapy for PTSD
Primary Purpose
PostTraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Equine Assisted Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for PostTraumatic Stress Disorder
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Equine Assisted Psychotherapy
Control
Arm Description
6 week Equine Assisted Psychotherapy program
Standard of Care, Existing PTSD therapy
Outcomes
Primary Outcome Measures
Change in 17-item PCL-Military (PTSD Symptoms)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03039361
First Posted
January 11, 2017
Last Updated
March 5, 2018
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT03039361
Brief Title
Equine Assisted Psychotherapy for PTSD
Official Title
Equine Assisted Psychotherapy for PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Equine Assisted Psychotherapy
Arm Type
Experimental
Arm Description
6 week Equine Assisted Psychotherapy program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of Care, Existing PTSD therapy
Intervention Type
Behavioral
Intervention Name(s)
Equine Assisted Psychotherapy
Other Intervention Name(s)
Equine Assisted Therapy
Intervention Description
Therapist will use Equine Assisted Growth and Learning Association (EAGALA) modeled Equine Assisted Psychotherapy.
Primary Outcome Measure Information:
Title
Change in 17-item PCL-Military (PTSD Symptoms)
Description
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.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark R Burge, MD
Organizational Affiliation
UNM Clinical Translational Science Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be provided in Lobo vault after finalization of the study.
Learn more about this trial
Equine Assisted Psychotherapy for PTSD
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