Investigation of Equine Assisted Therapy for Post-Traumatic Stress Disorder
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Equine Assisted Therapy (EAT)
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, Equine Assisted Therapy
Eligibility Criteria
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
Sites / Locations
- Western UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Equine Assisted Therapy (EAT)
Arm Description
Equine Assisted Therapy (EAT) treatment group
Outcomes
Primary Outcome Measures
Understanding of effects/effectiveness of EAT for PTSD.
PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5)
Secondary Outcome Measures
Understanding of effects/effectiveness of EAT for PTSD-related moods and emotions.
Positive and Negative Affect Scale (PNAS)
Understanding of effects/effectiveness of EAT for PTSD-related self esteem issues.
Rosenberg Self Esteem Scale
Full Information
NCT ID
NCT02816788
First Posted
June 16, 2016
Last Updated
August 21, 2022
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02816788
Brief Title
Investigation of Equine Assisted Therapy for Post-Traumatic Stress Disorder
Official Title
Investigation of Equine Assisted Therapy for Post-Traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In partnership with SARI Therapeutic Riding (SARI TR) and other equine therapy locations, Brescia University College, at the University of Western Ontario, will study the use of Equine Assisted Therapy (EAT) for military veterans and "first reponders" (emergency services personell) diagnosed with Post-Traumatic Stress Disorder. Data will be collected through tests and questionnaires, and follow-up interviews with participants. It is expected that after a series of EAT sessions, the social, emotional and psychological well-being of participants will be improved and PTSD symptoms alleviated.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
PTSD, Equine Assisted Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, within subjects comparison. Pre- and post-intervention comparisons.
Masking
None (Open Label)
Masking Description
No masking.
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Equine Assisted Therapy (EAT)
Arm Type
Experimental
Arm Description
Equine Assisted Therapy (EAT) treatment group
Intervention Type
Behavioral
Intervention Name(s)
Equine Assisted Therapy (EAT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Understanding of effects/effectiveness of EAT for PTSD.
Description
PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Understanding of effects/effectiveness of EAT for PTSD-related moods and emotions.
Description
Positive and Negative Affect Scale (PNAS)
Time Frame
6 months
Title
Understanding of effects/effectiveness of EAT for PTSD-related self esteem issues.
Description
Rosenberg Self Esteem Scale
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne MC Barnfield, PhD
Phone
519-432-8353
Ext
28246
Email
abarnfie@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
John B Mitchell, PhD
Phone
519-432-8353
Ext
28116
Email
jbmitche@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne MC Barnfield, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Patterson
Phone
519-661-2111
Ext
82256
Email
kpatte32@uwo.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
Yorke, J., Adams, C., &Coady, N. (2008). Therapeutic value of equine-human bonding in recovery from trauma. Anthrozoös, 21(1), 17-33.
Results Reference
background
Citation
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.
Results Reference
background
Learn more about this trial
Investigation of Equine Assisted Therapy for Post-Traumatic Stress Disorder
We'll reach out to this number within 24 hrs