NCT05527509

Brief Summary

The Royal Canadian Mounted Police (RCMP), like all public safety personnel (PSP), are frequently exposed to potentially psychologically traumatic events that contribute to posttraumatic stress injuries (PTSI). Addressing PTSI is impeded by the limited available research. The RCMP are working to build evidence-based solutions to PTSI and other mental health challenges facing their members, which by extension will help all PSP, as part of the Canadian Government Federal Framework on Posttraumatic Stress Disorder. A key element is the "Longitudinal Study of Operational Stress Injuries / Étude longitudinale sur les traumatismes liés au stress opérationnel", a study which has been renamed "Risk and Resiliency Factors in the RCMP: A Prospective Investigation", and is referred to as the "RCMP Study" for short. The RCMP Study has been detailed online (www.rcmpstudy.ca) and in a recently published peer-reviewed protocol paper, "The Royal Canadian Mounted Police (RCMP) Study: protocol for a prospective investigation of mental health risk and resilience factors" (https://doi.org/10.24095/hpcdp.42.8.02). The RCMP Study, part of the concerted efforts by the RCMP to reduce PTSI by improving access to evidence-based assessments, treatments, and training as well as participant recruitment and RCMP Study developments to date. The RCMP Study has been designed to (1) develop, deploy and assess the impact of a system for ongoing annual, monthly and daily evidence-based assessments; (2) evaluate associations between demographic variables and PTSI; (3) longitudinally assess individual differences associated with PTSI; (4) augment the RCMP Cadet Training Program with skills to proactively mitigate PTSI; and (5) assess the impact of the augmented training condition (ATC) versus the standard training condition (STC). Participants in the STC (n = 480) and ATC (n = 480) are assessed before and after training and annually for 5 years on their deployment date; they also complete brief monthly and daily surveys. The RCMP Study results are expected to benefit the mental health of all participants, RCMP and PSP by reducing PTSI among all who serve.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
960

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Apr 2019Dec 2029

Study Start

First participant enrolled

April 22, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Expected
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

5.6 years

First QC Date

August 29, 2022

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • Change in Posttraumatic Stress Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)

    Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.

    Time 1 (pre-training; week 1), Time 2 (post-training; week 26)

  • Sustained Posttraumatic Stress Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)

    Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.

    Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)

  • Change in Major Depressive Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)

    Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.

    Time 1 (pre-training; week 1), Time 2 (post-training; week 26)

  • Sustained Major Depressive Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)

    Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.

    Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)

  • Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)

    Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.

    Time 1 (pre-training; week 1), Time 2 (post-training; week 26)

  • Sustained Generalized Anxiety Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)

    Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.

    Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)

  • Change in Panic Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)

    Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.

    Time 1 (pre-training; week 1), Time 2 (post-training; week 26)

  • Sustained Panic Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)

    Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.

    Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)

Study Arms (2)

Standard Training Condition (STC)

ACTIVE COMPARATOR

The STC has received the "standard" RCMP Depot Division ("Depot") Cadet Training Program as has been provided to cadets prior to June 2022. The STC and the ATC will complete the same standardized self-report assessments, clinical interview assessments, and biometric assessments, and receive the same feedback and reporting based on those assessments.

Behavioral: Active Monitoring

Augmented Training Condition (ATC)

EXPERIMENTAL

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based cognitive-behavioral intervention designed to cultivate constructive approach-oriented emotional engagement. The 13-week Emotional Resilience Training (ERST) is an adaptation of the UP designed for use as a proactive training course. The ERST frames emotional experiences as natural responses to threat, rather than pathological occurrences to avoid; as such, the ERST is well-suited for mitigating health challenges and the skills may also help PSP to support persons in distress, including other PSP and the community members they all serve. The ERST training materials include an instructor guide, didactic PowerPoints, and a trainee workbook. The ERST was designed for seamless integration with the Cadet Training Program, effective June 2022, which is what creates the augmented training arm (i.e., the ATC).

Behavioral: Emotional Resilience Skills Training (ERST)

Interventions

The ERST training is designed as a "train the trainer" model. Sauer-Zavala, a co-developer of the UP, personally trained a group of RCMP trainers during a week-long interactive workshop. The trainers continue to have access to Sauer-Zavala for optional follow-up consultation and support related to delivery of the ERST training for questions or to address any issues that arise during training. Having consultation and support available for the trainers should help to offset concerns raised about ensuring training fidelity subsequent to other mental health programs. Participants have ongoing access to ERST to support skill retention after training is completed, which should help to offset previous indications of problems with skill development for mental health programs.

Also known as: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP)
Augmented Training Condition (ATC)

Participants in the STC will be assessed for at least 66 months, via full assessments (i.e., self-report surveys, clinical interviews), monthly assessments (i.e., \~20 minute self-report surveys), daily assessments (i.e., \~1 minute self-report surveys), and biometric assessments. The self-monitoring and feedback should be inherently beneficial and should facilitate earlier access to evidence-based care, which is why the STC is considered an active comparator.

Standard Training Condition (STC)

Eligibility Criteria

Age19 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cadets starting the RCMP Cadet Training Program

You may not qualify if:

  • Anyone other than cadets starting the RCMP Cadet Training Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S0A2, Canada

RECRUITING

Related Publications (2)

  • Carleton RN, Kratzig GP, Sauer-Zavala S, Neary JP, Lix LM, Fletcher AJ, Afifi TO, Brunet A, Martin R, Hamelin KS, Teckchandani TA, Jamshidi L, Maguire KQ, Gerhard D, McCarron M, Hoeber O, Jones NA, Stewart SH, Keane TM, Sareen J, Dobson K, Asmundson GJG. The Royal Canadian Mounted Police (RCMP) Study: protocol for a prospective investigation of mental health risk and resilience factors. Health Promot Chronic Dis Prev Can. 2022 Aug;42(8):319-333. doi: 10.24095/hpcdp.42.8.02.

    PMID: 35993603BACKGROUND
  • Khoury JMB, Jamshidi L, Shields RE, Nisbet J, Afifi TO, Fletcher AJ, Stewart SH, Asmundson GJG, Sauer-Zavala S, Kratzig GP, Carleton RN. Putative risk and resiliency factors among Royal Canadian Mounted Police cadets. Front Psychol. 2023 Mar 15;14:1048573. doi: 10.3389/fpsyg.2023.1048573. eCollection 2023.

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressive Disorder, MajorPanic DisorderGeneralized Anxiety DisorderWounds and InjuriesStress Disorders, TraumaticTrauma and Stressor Related DisordersCompassion Fatigue

Condition Hierarchy (Ancestors)

Mental DisordersDepressive DisorderMood DisordersAnxiety DisordersMental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorOccupational StressStress, Psychological

Study Officials

  • R. Nicholas Carleton, PhD

    University of Regina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

R. Nicholas Carleton, PhD

CONTACT

Jonathan Burry, PM

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The RCMP Study necessarily uses a longitudinal prospective sequential experimental cohort design to create a clustered randomized trial that engages individual participants for 5.5 years. The structure of the Cadet Training Program does not allow for randomizing individual participants or individual groups of participants; nevertheless, meta-analytic evidence suggests that results from studies using this design and results from true randomized controlled trials do not typically differ meaningfully or statistically significantly, and both methods produce comparable groups at baseline.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2022

First Posted

September 2, 2022

Study Start

April 22, 2019

Primary Completion

December 1, 2024

Study Completion (Estimated)

December 1, 2029

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

There are ethical and privacy concerns with respect to sharing the participant data, even after anonymization; as such, requests to access the datasets should be directed to the primary investigator and will be addressed on a case-by-case basis in connection with the University of Regina Research Ethics Board.

Locations