- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816788
Investigation of Equine Assisted Therapy for Post-Traumatic Stress Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to evaluate outcomes of participation in Equine Assisted Therapy for those with a history of PTSD.
This study protocol will be a within subjects design: Treatment group with pre- and post-intervention comparisons. Participants will be Military Veterans and "first responders" (emergency services personell) with prior diagnosis of PTSD; N=8 to 10.
Procedures for treatment group: The treatment group will engage in sets of EAT sessions to be run at SARI Therapeutic Riding (SARI TR) and other equine therapy locations. A typical EAT session will involve beginning the session by checking in as a group, engaging in one or two activities with the horses and then processing the activity as a group. Each session will also end with a check out. The activities with equines will range from observation/educational, grooming, reflective work involving creative expression with writing/art, or more active activities such as leading. Each session will have an overall topic which will provide the framework for the session. Interactions with equines will take place in the indoor arena (an enclosed space for riding/training horses), whilst other aspects of the sessions will take place in the main lounge. Sessions will be conducted by a Clinical Counsellor certified with their Provincial Counselling and Psychotherapy Association, assisted by other certified personnel, including those with horse handling experience. Each session will include up to eight to ten participants. There will be two persons with therapeutic expertise and one with horse/TR experience attending to participants at all times during interaction with equines. Sessions will usually last about two and a half hours, incorporating psychotherapy and interacting with equines, over a course of several sessions.
General procedure: Military Veterans and first responders with PTSD will be recruited from the local Occupational Stress Injury Social Support (OSISS) PTSD support group and similar organizations. This service "is a partnership program between the Department of National Defence and Veterans Affairs Canada" (OSISS website) created to provide peer support to Canadian Forces personnel, Veterans and their families. The OSISS provides peer support and aids in linking members to appropriate services, programmes and supports. Data will be collected through questionnaire-type tests and post-session interview of participants. A set of short tests, the Rosenberg Self-esteem Scale, the Positive and Negative Affect Scale (PNAS), and the PTSD Checklist for DSM-5 (PCL-5) will be administered. Participants will complete sets of tests at pre-session, post-session, and follow-up, and will be interviewed one week after the end of the study in order to obtain further data. Longer-term follow-up is also anticipated, with measures being repeated at further time points (e.g., one-, three-, and six-month follow-up) after completion of EAT sessions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne MC Barnfield, PhD
- Phone Number: 28246 519-432-8353
- Email: abarnfie@uwo.ca
Study Contact Backup
- Name: John B Mitchell, PhD
- Phone Number: 28116 519-432-8353
- Email: jbmitche@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- Western University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Post-Traumatic Stress Disorder (PTSD)
- with veteran or "first responder" status
- Both of these ascertained by self-report, confirmed by membership in Occupational Stress Injury Social Support (OSISS) group or similar organization
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Equine Assisted Therapy (EAT)
Equine Assisted Therapy (EAT) treatment group
|
Psychotherapy incorporating use of equines (Equine Assisted Therapy; EAT) to facilitate therapy to improve the social, emotional and psychological well-being of participants and alleviate PTSD symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Understanding of effects/effectiveness of EAT for PTSD.
Time Frame: 6 months
|
PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Understanding of effects/effectiveness of EAT for PTSD-related moods and emotions.
Time Frame: 6 months
|
Positive and Negative Affect Scale (PNAS)
|
6 months
|
Understanding of effects/effectiveness of EAT for PTSD-related self esteem issues.
Time Frame: 6 months
|
Rosenberg Self Esteem Scale
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne MC Barnfield, PhD, Western University
Publications and helpful links
General Publications
- Duncan, R., Critchley, S., & Marland, J. (2014). Can Praxis: A Model of Equine Assisted Learning (EAL) for PTSD. Canadian Military Journal 14(2), 64-69.
- Johnson, R. A. (2015). Effects of Equine Assisted Activities on PTSD Symptoms, Coping Self-Efficacy, Emotion Regulation, and Social Engagement in Military Veterans. Horses and Humans Research Foundation Final Grant Reporting. Retrieved from: http://www.horsesandhumans.org/RA_Johnson_Final_Grant_Report_12-2015.pdf
- Yorke, J., Adams, C., &Coady, N. (2008). Therapeutic value of equine-human bonding in recovery from trauma. Anthrozoös, 21(1), 17-33.
- Barnfield, A. M. C. (2015). A response to Anestis, Anestis, Zawilinski, Hopkins and Lilienfeld (2014). Scientific and Educational Journal of Therapeutic Horse Riding, 2015, 10-15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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