Stress Disorders, Post-TraumaticNCT02816788
Investigation of Equine Assisted Therapy for Post-Traumatic Stress Disorder
A study testing Equine Assisted Therapy (EAT) in people with Stress Disorders, Post-Traumatic, run by Western University, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Equine Assisted Therapy (EAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2017to 19 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Equine Assisted Therapy (EAT)
- Keywords
- PTSD, Equine Assisted Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine Assisted Therapy (EAT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Equine Assisted Therapy (EAT) | Experimental | Equine Assisted Therapy (EAT) treatment group Receives: Behavioral: Equine Assisted Therapy (EAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of effects/effectiveness of EAT for PTSD.
PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5)
Measured: 6 months
Secondary outcomes (2)
Understanding of effects/effectiveness of EAT for PTSD-related moods and emotions.
Positive and Negative Affect Scale (PNAS)
Measured: 6 months
Understanding of effects/effectiveness of EAT for PTSD-related self esteem issues.
Rosenberg Self Esteem Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start20 Jun 2017
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Why it stopped: Variety of issues, including imminent retirement of principal investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, within subjects comparison. Pre- and post-intervention comparisons.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Barnfield, Western University, Canada
- Investigators
- Anne MC Barnfield, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816788
- Sponsor's protocol ID
- 108102
- Status last verified
- Mar 2024
- First submitted
- 16 Jun 2016
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Equine Assisted Therapy for Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02816788
- Acronym / sponsor ID
- 108102
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, Equine Assisted Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Variety of issues, including imminent retirement of principal investigator.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, within subjects comparison. Pre- and post-intervention comparisons.
| Arm | Type | Receives |
|---|---|---|
| Equine Assisted Therapy (EAT) | Experimental | Behavioral: Equine Assisted Therapy (EAT)Equine Assisted Therapy (EAT) treatment group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Equine Assisted Therapy (EAT)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. | Behavioural | Equine Assisted Therapy (EAT) |
Primary outcome
Understanding of effects/effectiveness of EAT for PTSD.
Time frame: 6 months
PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5)
2 secondary outcomes
Understanding of effects/effectiveness of EAT for PTSD-related moods and emotions.
Time frame: 6 months
Understanding of effects/effectiveness of EAT for PTSD-related self esteem issues.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Variety of issues, including imminent retirement of principal investigator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- BackgroundDuncan, R., Critchley, S., & Marland, J. (2014). Can Praxis: A Model of Equine Assisted Learning (EAL) for PTSD. Canadian Military Journal 14(2), 64-69.
- BackgroundJohnson, 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
- BackgroundYorke, J., Adams, C., &Coady, N. (2008). Therapeutic value of equine-human bonding in recovery from trauma. Anthrozoös, 21(1), 17-33.
- BackgroundBarnfield, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne MC Barnfield, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equine Assisted Therapy (EAT) in people with Stress Disorders, Post-Traumatic, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Variety of issues, including imminent retirement of principal investigator.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding of effects/effectiveness of EAT for PTSD. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816788, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.