Examining EAL for PTSD

Posttraumatic Stress Disorder Clinical Trial

— EAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579717
• Other study ID #: 14547
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: Stephanie Penta, BSc
• Phone: 226-600-3597
• Email: pentas[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Equine Assisted Learning
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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	University of Regina, University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Experience in EAL	Participant experience in EAL as measured by a semi-structured, qualitative interview.	8 weeks
Primary	PTSD symptomatology	Changes in performance on the Clinician Administered PTSD Scale (structured interview) at pre, post, and follow-up.	20 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Mental health symptomatology	Changes in performance on the Mini International Neuropsychiatric Interview (structured interview) at pre, post, and follow-up.	20 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Heart rate variability	Changes in heart rate variability over time, as measured by a Garmin VivoActive 4 smartwatch.	20 weeks
Secondary	Oxygen saturation	Changes in oxygen saturation over time, as measured by a Garmin VivoActive 4 smartwatch.	20 weeks
Secondary	Sleep quality	Changes in sleep quality over time, as measured by a Garmin VivoActive 4 smartwatch.	20 weeks