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
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 measure
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 (if study stopped)
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)
Total final enrolment
2831
Participant exclusion criteria
N/A
Recruitment start date
01/10/2016
Recruitment end date
31/05/2018
Locations
Countries of recruitment
Canada
Trial participating centre
Saint-Jean-sur-Richelieu, Québec
J0J 1R0
Canada
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
30/06/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31664960 (added 31/10/2019)