Testing the efficacy of a mental health education program for military recruits

ISRCTN ISRCTN52557050
DOI https://doi.org/10.1186/ISRCTN52557050
Secondary identifying numbers 2016-021
Submission date
13/10/2016
Registration date
24/10/2016
Last edited
31/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Deniz Fikretoglu
Scientific

1133 Sheppard Ave. W
Toronto
M3K 2C9
Canada

Study information

Study designAnglophones: Single-centre double-blinded group randomized control trial design Francophones: Single-centre group non-randomized/uncontrolled longitudinal (pre-post-post) observational study
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Other
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleTesting the efficacy and effectiveness of the Road to Mental Readiness (R2MR) mental health training program during basic military qualification
Study objectivesThe 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(s)Human Research Ethics Committee (HREC), Defence Research & Development Canada - Toronto, 21/06/2016, ref: 2016-021
Health condition(s) or problem(s) studiedPsychological well-being
InterventionIncoming 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 typeBehavioural
Primary outcome measureThe 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 measuresTraining graduation rate, indicated by performance in the BMQ course at week 9 (completion of the BMQ)
Overall study start date01/05/2016
Completion date31/12/2018

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participants53 platoons (approximately 60 members in each platoon)
Total final enrolment2831
Key inclusion criteriaGroup 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
Key exclusion criteriaN/A
Date of first enrolment01/10/2016
Date of final enrolment31/05/2018

Locations

Countries of recruitment

  • Canada

Study participating centre

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

Sponsor information

Canadian Forces Health Services
Government

1745 Alta Vista Drive
Ottawa
K1A 0K6
Canada

ROR logo "ROR" https://ror.org/03rqcfv80

Funders

Funder type

Government

Canadian Forces Health Services

No information available

Results and Publications

Intention to publish date30/06/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planTo be confirmed at a later date
IPD sharing planParticipant level data will not be disclosed in order to ensure confidentiality for study participants. Data will be held by Defence Research and Development Canada.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 29/10/2019 31/10/2019 Yes No

Editorial Notes

31/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
17/05/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2018 to 31/05/2018.
2. The intention to publish date was changed from 31/12/2019 to 30/06/2019.