Condition category
Mental and Behavioural Disorders
Date applied
13/10/2016
Date assigned
24/10/2016
Last edited
20/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The Canadian Armed Forces recognize the importance of maintaining good mental health among personnel. The Road to Mental Readiness (R2MR) mental health education and training program was developed and launched to help military members maintain good mental health throughout their career. All Canadian Armed forces non-commissioned member recruits receive R2MR mental health training during Basic Military Qualification training. These key components or objectives are aimed at increasing knowledge about mental health, teaching stress management skills, and changing negative attitudes towards mental health service use. The aim of this study is to assess how well mental health training works with respect to mental health and well-being, resilience, training performance, and attitudes.

Who can participate?
Anglophone and Francophone Canadian Armed forces non-commissioned member recruits partaking in the Basic Military Qualification (BMQ) training at Canadian Forces Leadership and Recruit School

What does the study involve?
Anglophone platoons are randomly allocated to receive the R2MR mental health education/training conducted either at the beginning or later on in BMQ. Francophone platoons are allocated to R2MR mental health training conducted at the beginning of the BMQ. All participants complete questionnaires assessing current mental health and well-being, resilience, performance, and attitudes at three times over the course of the BMQ training. Time commitment for this study is 80 minutes at each of the three assessments (start, mid-point and end of the BMQ).

What are the possible benefits and risks of participating?
This study will provide information on how well mental health training works within a military context. The results of this study will indicate how well mental health training works and whether it needs to be changed to better meet the needs of Canadian Armed Forces recruits. There are no known risks associated with this study.

Where is the study run from?
Saint-Jean-sur-Richelieu, Québec, Canada

When is the study starting and how long is it expected to run for?
May 2016 to December 2018

Who is funding the study?
Canadian Forces Health Services

Who is the main contact?
Dr Deniz Fikretoglu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Deniz Fikretoglu

ORCID ID

Contact details

1133 Sheppard Ave. W
Toronto
M3K 2C9
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016-021

Study information

Scientific title

Testing the efficacy and effectiveness of the Road to Mental Readiness (R2MR) mental health training program during basic military qualification

Acronym

Study hypothesis

The Road to Mental Readiness (R2MR) mental health training program at Basic Military Qualification (BMQ) has three objectives:
1. To increase basic mental health literacy
2. To teach stress management skills
3. To change attitudes and intentions towards mental health service use
The overall objective of this study is to assess the efficacy of R2MR in improving psychological health, psychological resilience, attitudinal and performance outcomes for Canadian Armed Forces (CAF) Non-Commissioned Member (NCM) recruits.

The trialists hypothesize that:
1. R2MR will have a beneficial effect on psychological health
2. R2MR will have a beneficial effect on psychological resilience
3. R2MR will have a beneficial effect on attitudes towards and intentions for mental health service use
4. R2MR will have a beneficial effect on performance in BMQ training
5. R2MR’s beneficial effects will be in the very small-to-medium range
6. R2MR’s beneficial effects will diminish over time, from immediately post-intervention to short-term follow-up

The trialists hypothesize in an exploratory fashion, that:
1. Stress management and mental health literacy will mediate the effects of R2MR
2. Some socio-demographic variables such as sex and education will moderate the effects of R2MR

Ethics approval

Human Research Ethics Committee (HREC), Defence Research & Development Canada - Toronto, 21/06/2016, ref: 2016-021

Study design

Anglophones: Single-centre double-blinded group randomized control trial design
Francophones: Single-centre group non-randomized/uncontrolled longitudinal (pre-post-post) observational study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Psychological well-being

Intervention

Incoming Anglophone platoons will be assigned, using blocked randomization, to either the Intervention (i.e., receiving R2MR early on in the BMQ) or a delayed intervention control (i.e., receiving R2MR later on in BMQ). R2MR involves participants attending a 160-minute class about mental health literacy, stress management skills, and attitudes towards mental healthcare. Baseline measures will be collected at the beginning, mid-point, and end of the BMQ training.

In the observational study of Francophone recruits, all Francophone platoons will receive R2MR at the beginning of BMQ. The data collection schedule will be identical to the Anglophone study.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The following measures will be collected at the beginning (week 2), mid-point (week 5), and end (week 9) of the BMQ training:
1. Psychological health, measured using the Patient Health Questionnaire, Kessler Psychological Distress Scale, and Subjective Units of Distress Scale
2. Psychological resilience, measured using the Connor-Davidson Resilience Scale and Test of Performance Strategies
3. Mental health service use attitudes and intentions, measured using the Canadian Armed Forces Mental Health Service Use Questionnaire and R2MR Program Evaluation Form

Secondary outcome measures

Training graduation rate, indicated by performance in the BMQ course at week 9 (completion of the BMQ)

Overall trial start date

01/05/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Group randomized controlled trial:
1. Anglophone
2. Canadian Armed Forces non-commissioned member recruits
3. Partaking in the Basic Military Qualification training at Canadian Forces Leadership and Recruit School
4. Ages 16-65, inclusive

Parallel observational study:
1. Francophone
2. Canadian Armed Forces non-commissioned member recruits
3. Partaking in the Basic Military Qualification training at Canadian Forces Leadership and Recruit School
4. Ages 16-65, inclusive

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

53 platoons (approximately 60 members in each platoon)

Participant exclusion criteria

N/A

Recruitment start date

01/10/2016

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Canada

Trial participating centre

Saint-Jean-sur-Richelieu, Québec
J0J 1R0
Canada

Sponsor information

Organisation

Canadian Forces Health Services

Sponsor details

1745 Alta Vista Drive
Ottawa
K1A 0K6
Canada

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Canadian Forces Health Services

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD sharing plan
Participant level data will not be disclosed in order to ensure confidentiality for study participants. Data will be held by Defence Research and Development Canada.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes