Examining EAL for PTSD

Study Overview
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Brief Summary
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This RCT will evaluate the efficacy of Equine Assisted Learning for reducing PTSD symptoms in public safety personnel (e.g., fire fighters, police, nurses, etc.).

Detailed Description
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The purpose of the proposed project is to investigate the effectiveness of Equine Assisted Learning (EAL) for reducing symptoms related to PTSD 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 randomized controlled trial design with pre-post and follow-up testing. Participants will be randomized into one of two groups: the intervention group will receive the EAL intervention for 8 weeks while waitlist control condition will not receive this treatment for the same amount of time. Data on PTSD symptom severity will be collected from all participants prior to the start of the EAL intervention (baseline), again within two weeks after the EAL intervention is complete (post), and then a final time three months after the EAL intervention ends (follow-up). The two groups will then be compared to determine whether there are differences in PTSD symptom severity between groups. To obtain a sufficient sample size while also running appropriately sized EAL groups of 10 per session, the investigators will conduct four rounds of randomization, Thus, the final sample size will be 80 (40 in the intervention condition and 40 in the waitlist control condition). All individuals in the waitlist control condition will be offered EAL following their completion of the study.

Official Title
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Examining the Benefit of Equine Assisted Learning for First Responders With Posttraumatic Stress Disorder

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Equine Assisted Learning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet diagnostic criteria for PTSD; Employed as a police officer, fire fighter, paramedic, nurse, or emergency dispatcher; and Fully vaccinated against COVID-19. Exclusion Criteria: Substance use that limits one's capacity to participate in the intervention; Suicidality; or Enrollment in another study investigating PTSD intervention efficacy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomized to an intervention group or a waitlist control group. Individuals in the waitlist control group will be offered the opportunity to participate in EAL once they have completed the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Equine Assisted Learning group<br>Participants in this group will receive 16 sessions of Equine Assisted Learning (EAL), facilitated by a trained clinician at Cartier Farms. | Behavioral: Equine Assisted Learning<br>* 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.<br>* Other names: EAL;|
| No Intervention: Waitlist control group<br>Participants in the waitlist control group will not receive EAL for the duration of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptomatology | Changes in performance on the Clinician Administered PTSD Scale (structured interview) at pre, post, and follow-up. | 20 weeks | 
| PTSD symptomatology | 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. | 20 weeks | 
| Emotion regulation | 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. | 20 weeks | 
| Dissociation | 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. | 20 weeks | 
| Moral injury | 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. | 20 weeks | 
| Body awareness | 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. | 20 weeks | 
| Sleep quality | 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. | 20 weeks | 
| Health complaints | 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. | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental health symptomatology | Changes in performance on the Mini International Neuropsychiatric Interview (structured interview) at pre, post, and follow-up. | 20 weeks | 
| Depression, anxiety, and stress symptomatology | 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. | 20 weeks | 
| Substance involvement | Changes in performance on the NIDA-modified Alcohol, Smoking, and Substance Involvement Test at pre, post, and follow-up. Scores can range between 0 and 27 with higher scores denoting greater level of risk associated with substance involvement. | 20 weeks | 
| Alcohol use disorder symptomatology | 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. | 20 weeks | 
| Cannabis use disorder symptomatology | 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. | 20 weeks | 
| Substance use disorder symptomatology | 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. | 20 weeks | 
| Resilience | 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. | 20 weeks | 
| Self-compassion | 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. | 20 weeks | 
| Cognitive functioning | Changes in performance on the Behaviour Rating Inventory of Executive Function - Adult Version at pre, post, and follow-up. Scores can range between 0 and 100 with higher scores denoting higher levels of dysfunction in domains of executive functioning. | 20 weeks | 
| Health and disability | 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. | 20 weeks | 
| Disability | 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. | 20 weeks | 
| Work functioning and productivity | 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. | 20 weeks | 
| Heart rate variability | Changes in heart rate variability over time, as measured by a Garmin VivoActive 4 smartwatch. | 20 weeks | 
| Oxygen saturation | Changes in oxygen saturation over time, as measured by a Garmin VivoActive 4 smartwatch. | 20 weeks | 
| Sleep quality | Changes in sleep quality over time, as measured by a Garmin VivoActive 4 smartwatch. | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EAL, PTSD, posttraumatic stress disorder, public safety personnel, first responder, Equine Assisted Learning, horse therapy