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Examining EAL for PTSD (EAL)

Primary Purpose

Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Equine Assisted Learning
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring EAL, PTSD, posttraumatic stress disorder, public safety personnel, first responder, Equine Assisted Learning, horse therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Equine Assisted Learning group

Waitlist control group

Arm Description

Participants in this group will receive 16 sessions of Equine Assisted Learning (EAL), facilitated by a trained clinician at Cartier Farms.

Participants in the waitlist control group will not receive EAL for the duration of the study.

Outcomes

Primary Outcome Measures

PTSD symptomatology
Changes in performance on the Clinician Administered PTSD Scale (structured interview) at pre, post, and follow-up.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Mental health symptomatology
Changes in performance on the Mini International Neuropsychiatric Interview (structured interview) at pre, post, and follow-up.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Heart rate variability
Changes in heart rate variability over time, as measured by a Garmin VivoActive 4 smartwatch.
Oxygen saturation
Changes in oxygen saturation over time, as measured by a Garmin VivoActive 4 smartwatch.
Sleep quality
Changes in sleep quality over time, as measured by a Garmin VivoActive 4 smartwatch.

Full Information

First Posted
September 28, 2022
Last Updated
March 13, 2023
Sponsor
McMaster University
Collaborators
University of Saskatchewan, University of Regina
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1. Study Identification

Unique Protocol Identification Number
NCT05579717
Brief Title
Examining EAL for PTSD
Acronym
EAL
Official Title
Examining the Benefit of Equine Assisted Learning for First Responders With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
University of Saskatchewan, University of Regina

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
EAL, PTSD, posttraumatic stress disorder, public safety personnel, first responder, Equine Assisted Learning, horse therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Equine Assisted Learning group
Arm Type
Experimental
Arm Description
Participants in this group will receive 16 sessions of Equine Assisted Learning (EAL), facilitated by a trained clinician at Cartier Farms.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
Participants in the waitlist control group will not receive EAL for the duration of the study.
Intervention Type
Behavioral
Intervention Name(s)
Equine Assisted Learning
Other Intervention Name(s)
EAL
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD symptomatology
Description
Changes in performance on the Clinician Administered PTSD Scale (structured interview) at pre, post, and follow-up.
Time Frame
20 weeks
Title
PTSD symptomatology
Description
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.
Time Frame
20 weeks
Title
Emotion regulation
Description
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.
Time Frame
20 weeks
Title
Dissociation
Description
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.
Time Frame
20 weeks
Title
Moral injury
Description
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.
Time Frame
20 weeks
Title
Body awareness
Description
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.
Time Frame
20 weeks
Title
Sleep quality
Description
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.
Time Frame
20 weeks
Title
Health complaints
Description
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.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Mental health symptomatology
Description
Changes in performance on the Mini International Neuropsychiatric Interview (structured interview) at pre, post, and follow-up.
Time Frame
20 weeks
Title
Depression, anxiety, and stress symptomatology
Description
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.
Time Frame
20 weeks
Title
Substance involvement
Description
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.
Time Frame
20 weeks
Title
Alcohol use disorder symptomatology
Description
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.
Time Frame
20 weeks
Title
Cannabis use disorder symptomatology
Description
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.
Time Frame
20 weeks
Title
Substance use disorder symptomatology
Description
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.
Time Frame
20 weeks
Title
Resilience
Description
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.
Time Frame
20 weeks
Title
Self-compassion
Description
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.
Time Frame
20 weeks
Title
Cognitive functioning
Description
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.
Time Frame
20 weeks
Title
Health and disability
Description
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.
Time Frame
20 weeks
Title
Disability
Description
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.
Time Frame
20 weeks
Title
Work functioning and productivity
Description
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.
Time Frame
20 weeks
Title
Heart rate variability
Description
Changes in heart rate variability over time, as measured by a Garmin VivoActive 4 smartwatch.
Time Frame
20 weeks
Title
Oxygen saturation
Description
Changes in oxygen saturation over time, as measured by a Garmin VivoActive 4 smartwatch.
Time Frame
20 weeks
Title
Sleep quality
Description
Changes in sleep quality over time, as measured by a Garmin VivoActive 4 smartwatch.
Time Frame
20 weeks
Other Pre-specified Outcome Measures:
Title
Experience in EAL
Description
Participant experience in EAL as measured by a semi-structured, qualitative interview.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Penta, BSc
Phone
226-600-3597
Email
pentas@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Chrysler, BA
Phone
905-517-7852
Email
chrysl@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret McKinnon, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9C0E3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephani

12. IPD Sharing Statement

Plan to Share IPD
No

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Examining EAL for PTSD

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