- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05579717
Examining the Effectiveness of EAL (EAL)
Examining the Effectiveness of Equine Assisted Learning for Trauma-exposed Public Safety Personnel
Study Overview
Detailed Description
The purpose of the proposed project is to investigate the effectiveness of Equine Assisted Learning (EAL) for reducing symptoms associated with trauma exposure among public safety personnel. EAL is an intervention in which mental health clinicians and equine specialists work together with clients to address a learning goal via unmounted interaction with a horse. Recent literature indicates that EAL shows promise in addressing a range of mental health diagnoses among a variety of populations, including military and Royal Canadian Mounted Police veterans with PTSD. The EAL intervention will be delivered at Cartier Farms in Spruce Home, Saskatchewan. Research components of this study will be conducted virtually via Zoom.
The investigators will employ a quasi-experimental design with pre-post and follow-up testing. Participants will be assigned one of two groups based on the time that they complete their initial baseline interview: (1) the intervention group will receive the EAL intervention for 8 weeks, while (2) the waitlist control condition will not receive this treatment for the same amount of time. Data on trauma exposure symptom severity will be collected from all participants prior to the start of the the study (baseline), again 8 weeks later (post), and then a final time 3 months later (follow-up). The two conditions will then be compared to determine whether there are differences in trauma exposure symptom severity between groups. To obtain a sufficient sample size while also running appropriately sized interventions of 6-10 participants per session, the researchers will conduct 4-6 rounds of group assignment. All individuals in the waitlist control condition will be offered EAL following their completion of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Saskatchewan
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Prince Albert, Saskatchewan, Canada, S6V5R2
- Cartier Farms
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English-speaking adults;
- Currently or previously employed as public safety personnel (e.g., police officer, fire fighter, paramedic, healthcare worker, emergency dispatcher, correctional officer);
- Reside in Saskatchewan;
- Meet diagnostic criteria for having experienced a Criterion A traumatic event;
- Able to provide written informed consent;
- Have access to a smart phone, tablet, or computer with a working microphone and camera; and
- Have access to consistent and reliable internet.
Exclusion:
- Meet/met current/past diagnostic criteria for several psychiatric, neurodevelopmental, and neurological conditions;
- History of severe head trauma with loss of consciousness or history of traumatic brain injury;
- Have previously completed at least half of the EAL curriculum at Cartier Farms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Equine Assisted Learning group
Participants in this group will receive 16 sessions of Equine Assisted Learning (EAL), facilitated by a trained clinician at Cartier Farms.
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EAL is an intervention in which mental health clinicians and equine specialists work together with clients to address a learning goal via unmounted interaction with a horse.
It is 16 sessions in length, at a rate of two sessions per week.
Other Names:
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No Intervention: Waitlist control group
Participants in the waitlist control group will not receive EAL for the duration of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PTSD symptomatology
Time Frame: 20 weeks
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Changes in performance on the Clinician Administered PTSD Scale (structured interview) at pre, post, and follow-up.
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20 weeks
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PTSD symptomatology
Time Frame: 20 weeks
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Changes in performance on the PTSD Checklist for DSM-5 at pre, post, and follow-up.
Scores can range between 0 and 80 with higher scores denoting higher PTSD symptomatology.
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20 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Emotion regulation
Time Frame: 20 weeks
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Changes in performance on the Difficulties in Emotion Regulation Scale, at pre, post, and follow-up.
Scores can range between 36 and 180 with higher scores denoting poorer emotion regulation.
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20 weeks
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Dissociation
Time Frame: 20 weeks
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Changes in performance on the Multiscale Dissociation Index at pre, post, and follow-up.
Scores can range between 0 and 120 with higher scores denoting higher dissociative symptomatology.
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20 weeks
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Moral injury
Time Frame: 20 weeks
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Changes in performance on the Moral Injury Assessment - Public Safety Personnel at pre, post, and follow-up.
Scores can range between 17 and 102 with higher scores denoting higher moral injury.
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20 weeks
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Body awareness
Time Frame: 20 weeks
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Changes in performance on the Multidimensional Assessment of Interoceptive Awareness - Version 2 at pre, post, and follow-up.
Scores can range between 0 and 185 with higher scores denoting greater body awareness.
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20 weeks
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Sleep quality
Time Frame: 20 weeks
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Changes in performance on the Pittsburgh Sleep Quality Index at pre, post, and follow-up.
Scores can range between 0 and 21 with higher scores denoting poorer sleep quality.
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20 weeks
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Health complaints
Time Frame: 20 weeks
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Changes in performance on the Physical Symptoms Questionnaire at pre, post, and follow-up.
Scores can range between 0 and 33 with higher scores denoting more health complaints.
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20 weeks
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Mental health symptomatology
Time Frame: 20 weeks
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Changes in performance on the Mini International Neuropsychiatric Interview (structured interview) at pre, post, and follow-up.
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20 weeks
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Depression, anxiety, and stress symptomatology
Time Frame: 20 weeks
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Changes in performance on the Depression Anxiety Stress Scale at pre, post, and follow-up.
Scores can range between 0 and 42 with higher scores denoting higher depression, anxiety, and/or stress symptomatology.
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20 weeks
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Alcohol use disorder symptomatology
Time Frame: 20 weeks
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Changes in performance on the Alcohol Use Disorder Identification Test at pre, post, and follow-up.
Scores can range between 0 and 40 with higher scores denoting higher AUD symptomatology.
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20 weeks
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Cannabis use disorder symptomatology
Time Frame: 20 weeks
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Changes in performance on the Cannabis Use Disorder Identification Test at pre, post, and follow-up.
Scores can range between 0 and 32 with higher scores denoting higher CUD symptomatology.
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20 weeks
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Substance use disorder symptomatology
Time Frame: 20 weeks
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Changes in performance on the Drug Use Disorder Identification Test at pre, post, and follow-up.
Scores can range between 0 and 44 with higher scores denoting higher SUD symptomatology.
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20 weeks
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Resilience
Time Frame: 20 weeks
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Changes in performance on the Brief Resilience Scale at pre, post, and follow-up.
Scores can range between 6 and 30 with higher scores denoting higher resilience.
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20 weeks
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Self-compassion
Time Frame: 20 weeks
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Changes in performance on the Self Compassion Scale at pre, post, and follow-up.
Scores can range between 26 and 130 with higher scores denoting higher self-compassion.
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20 weeks
|
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Health and disability
Time Frame: 20 weeks
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Changes in performance on World Health Organization's Disability Assessment Schedule 12 at pre, post, and follow-up.
Scores can range between 0 and 100 with higher scores denoting greater disability.
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20 weeks
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Disability
Time Frame: 20 weeks
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Changes in performance on the Sheehan Disability Scale at pre, post, and follow-up.
Scores can range between 0 and 44 with higher scores denoting greater disability.
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20 weeks
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Work functioning and productivity
Time Frame: 20 weeks
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Changes in performance on Lam's Employment and Productivity Scale at pre, post, and follow-up.
Scores can range between 0 and 28 with higher scores denoting more severe work impairment.
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20 weeks
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Substance involvement
Time Frame: 20 weeks
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Changes in performance on the World Health Organization's Alcohol, Smoking, and Substance Involvement Test at pre, post, and follow-up.
Each question on the ASSIST has a checklist set of responses to choose from to measure substances used in the past, and each response from questions 2 to 7 has a numerical score.
Higher scores indicate more significant substance involvement.
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20 weeks
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Exposure to childhood trauma
Time Frame: Completed once at baseline
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Baseline description of trauma experienced in childhood based on the Childhood Trauma Questionnaire, which is a 28-item checklist where more endorsed traumatic experiences indicates more exposure to childhood trauma.
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Completed once at baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heart rate variability
Time Frame: 20 weeks
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Changes in heart rate variability over time, as measured by a Garmin VivoActive 4 smartwatch.
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20 weeks
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Sleep quality
Time Frame: 20 weeks
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Changes in sleep quality over time, as measured by a Garmin VivoActive 4 smartwatch.
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20 weeks
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Experience in EAL
Time Frame: 8 weeks
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Participant experience in EAL as measured by a semi-structured, qualitative interview.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Margaret McKinnon, PhD, CPsych, McMaster University
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 (Actual)
Study Record Updates
Last Update Posted (Estimated)
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
- 14547
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
product manufactured in and exported from the U.S.
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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