Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001438347
Ethics application status
Approved
Date submitted
4/10/2017
Date registered
11/10/2017
Date last updated
19/03/2021
Date data sharing statement initially provided
8/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of mental skills training in the military context
Scientific title
Effectiveness of mental skills training in the military context: A quasi-randomised trial with the Canadian Armed Forces
Secondary ID [1] 292996 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human performance 304908 0
Resilience 304993 0
Condition category
Condition code
Mental Health 304238 304238 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to the intervention arm will receive a two-day (approximately 8 hours per day), modularised psychological skills training (PST) package. The program will be delivered to members in groups of 20-40 individuals; it is anticipated that the intervention will be delivered to approximately 15 member groups or units. All sessions will be delivered face to face by a facilitation team that includes two experienced human performance specialists (with Masters/PhD level educational training in sport psychology) and at least 1 co-facilitator (member of the Canadian Armed Forces who has received specialist training in the content and delivery of the intervention package). All intervention sessions will be delivered at formal training facilities of the Canadian Armed Forces using a PowerPoint package displayed on a projector screen and hardcopy manual for participants. The same two human performance specialists will lead the delivery of the intervention, adhering to a single training protocol to ensure standardised delivery in terms of structure and content across member groups. The co-facilitators will vary depending on their availability throughout the intervention period. The PST package includes education delivered by human performance specialists, videos of current members who discuss their experiences with specific psychological skills, breakout sessions for participants to engage in discussion with peers, and practical skill exercises where participants test out strategies taught in the education component. In terms of content, the PST program incorporates modules on stress and activation; activation management; confidence; self-talk; imagery; goal setting; routines; attention control; recovery; mindfulness; and self-regulation. Participants will be provided with a hardcopy course pack including all PowerPoint slides and exercises used during the training package.

As the training program is delivered by the same two human performance specialists, the intervention will be rolled out sequentially over a period of approximately 8 months. Units who have expressed an interest in this study will be provided with a schedule in which 2-day blocks are dispersed across the study period in approximately 20 cohorts. For each cohort, there will be two dates available, which will be represented as “A” (intervention) or “B” (waitlist control). Group A will receive the intervention at the start of the block, whereas Group B will receive the intervention after the post-assessments have been completed. Unit training coordinators will choose from these available options as to when they can complete the training by selecting their chosen date. Units will have no visibility as to whether the option they have chosen is the intervention or waitlist control (i.e., blinded); all they will see are the dates offered and the “closing date” for sign-up to each cohort, which is 2 weeks prior to the date allocated to Group A (i.e., receives the intervention as part of the study).

Co-facilitators will receive specialist training prior to the roll out of the intervention. This training will involve between 3-5 serials or iterations, depending on requirements and availability of personnel. The co-facilitator training will occur over a period of 5 days, and will include in-person training in which we cover the entire training content (with time for review/questions for each module); and 2 days of adult education content with practical public speaking practice and a pass/fail evaluation component where each participant delivers part of the course content to their peers, and is provided a score and feedback.
The training is delivered in person, using an interactive approach comprised of PowerPoint presentations, individual self-reflective exercises, group discussion, video, and practical teaching/public speaking exercises. The training will be delivered by a team of mental performance specialists (with masters or PhD level training) who developed the intervention program.
Intervention code [1] 299236 0
Behaviour
Comparator / control treatment
Waitlist control; these individuals will receive the intervention after the 6-week post-assessment has been completed.
Control group
Active

Outcomes
Primary outcome [1] 303523 0
Self-reported psychological skill usage: the frequency with which participants employ psychological strategies (e.g., goal setting, self-talk, imagery, relaxation techniques) for the purpose of influencing performance positively in a training or operational context. For the purposes of this study, instructions and item-stems of the Test of Performance Strategies (Hardy et al., 2010; Thomas et al., 1999) will be revised to reflect the nature of military training and operations for operator constituents and specialists and in training and garrison context for supporters, as compared to sport competition and practice.

Thomas, P. R., Murphy, S. M., & Hardy, L. (1999). Test of Performance Strategies: Development and preliminary validation of a comprehensive measure of athletes’ psychological skills. Journal of Sports Sciences, 17, 697-711.

Hardy, L., Roberts, R., Thomas, P. R., & Murphy, S. M. (2010). Test of Performance Strategies (TOPS): Instrument refinement using confirmatory factor analysis. Psychology of Sport & Exercise, 11, 27-35.
Timepoint [1] 303523 0
At baseline (week 0) and 6 weeks after participants have received the intervention (week 6).
Primary outcome [2] 303534 0
Self-reported mental toughness (level): an assessment of a psychological resource characterised by purpose, flexibility, and efficiency for the enactment and maintenance of goal-direct pursuits (Gucciardi et al., 2015).

Gucciardi, D. F., Hanton, S., Gordon, S., Mallett, C. J., & Temby, P. (2015). The concept of mental toughness: Tests of dimensionality, nomological network, and traitness. Journal of Personality, 83, 26-43.
Timepoint [2] 303534 0
At baseline (week 0) and 6 weeks after participants have received the intervention (week 6).
Secondary outcome [1] 339192 0
Self-reported resilience: an assessment of one’s perceived ability to bounce back after stress or adversity.

Smith, B. W., Dalen, J., Wiggins, K., Tooley, E., Christopher, P., & Bernard, J. (2008). The brief resilience scale: Assessing the ability to bounce back. International Journal of Behavioral Medicine, 15(3), 194-200.
Timepoint [1] 339192 0
At baseline (week 0) and 6 weeks after participants have received the intervention (week 6).
Secondary outcome [2] 339215 0
Self-reported mental toughness (stability): perceived stability of one’s mental toughness across situations, contexts and time (e.g., within-person variability). This bespoke scale was created based on adaptation of work on self-esteem stability (Dykman, 1998).

Dykman, B. J. (1998). Integrating cognitive and motivational factors in depression: Initial tests of a goal-oriented approach. Journal of Personality & Social Psychology, 74, 139-158.
Timepoint [2] 339215 0
At baseline (week 0) and 6 weeks after participants have received the intervention (week 6).
Secondary outcome [3] 339216 0
Self-reported general self-efficacy: an assessment of one’s perceived capability to achieve desired objectives across various achievement-related situations (Chen et al., 2001).

Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. Organisational Research Methods, 4, 62-83.
Timepoint [3] 339216 0
At baseline (week 0) and 6 weeks after participants have received the intervention (week 6).
Secondary outcome [4] 370188 0
Mental health literacy: pertains to an individual’s understanding of and beliefs toward mental health issues and behaviors. The original mental health literacy assessment tool is a 14-item measure assessing understanding of the Mental Health Continuum Model, confidence in one’s ability to recognize signs of mental health challenge and knowledge of available resources. Items are rated on a 5-point Likert ranging from strongly disagree to strongly agree. A recent validation study (unpublished) has identified redundancy in 4-items. Thus, the revised 10-item version of this scale will be used in the present study. Only items that pertain to individual (vs team member) will be included.

Frank, C., Lee, J.E.C, Fikretoglu, D. & Bailey, S. (in press). Validation of a mental health literacy assessment tool.
Timepoint [4] 370188 0
At baseline (week 0) and 6 weeks after participants have received the intervention (week 6).
Secondary outcome [5] 370189 0
Mental health service use: based on the Theory of Planned Behavior, assesses attitudes and beliefs toward care seeking measured indirectly and directly.

Fikretoglu, D., Blais, A-R., & Lam, Q. (2015). Development and validation of a new Theory of Planned Behavior questionnaire for mental health service use.
Timepoint [5] 370189 0
At baseline (week 0) and 6 weeks after participants have received the intervention (week 6).

Eligibility
Key inclusion criteria
Participants will be active members of the Canadian Armed Forces.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Members who have volunteered to co-deliver the training package with the researchers. These individuals will be or have been provided with in-depth training and exposure to content of the psychological skills training material via a comprehensive ‘Train the Trainer’ program.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 382 participants (n = 191 in each arm) is required to provide 90% power (a = .05) to detect the smallest effect size of interest (d = .30) in a non-clustered analysis. We adjusted the required sample size in order to take into account the clustered nature of the data. A conservative estimate of the ICC as .012 (doi: 10.1037/apl0000021) and approximate group size of 30 individuals results in a design effect of 1.35 (N = 516). Allowing an attrition rate of 10% between pre- and post-assessments, we would require a total sample of 568 members.

We will use latent growth modeling (LGM) in Mplus 8 (Muthén & Muthén, 2015) with maximum likelihood estimation and accounting for clustering effects (TYPE = COMPLEX function) to determine the amount of individual change between the two time points (Voelkle, 2007). LGM encompasses participants’ starting point (intercept) and change between assessment points (slope) for each individual, thereby permitting an examination of intra-individual change over time as well as inter-individual differences in intra-individual change. Experimental group (intervention versus control) dummy coded and included in the analysis as a predictor of the intercept and slope factors. This analysis framework will be used individually for all primary and secondary outcomes variables.

Muthén, L.K., & Muthén, B. (2015). Mplus users guide (7th ed.). Los Angeles, CA: Muthén & Muthén.

Voelkle, M.C. (2007). Latent growth curve modeling as an integrative approach to analysis of change. Psychology Science, 49, 375-414.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/05/2019
Actual
12/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2021
Actual
Sample size
Target
568
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 9249 0
Canada
State/province [1] 9249 0
Ottawa

Funding & Sponsors
Funding source category [1] 297622 0
Government body
Name [1] 297622 0
Department of National Defence
Country [1] 297622 0
Canada
Primary sponsor type
Individual
Name
Paige Mattie
Address
Mental Performance Manager
Canadian Forces Morale & Welfare Services
Department of National Defence
4210 Labelle St. Ottawa Ontario, K1J 1J7
Country
Canada
Secondary sponsor category [1] 296638 0
University
Name [1] 296638 0
Curtin University
Address [1] 296638 0
Building 408, School of Physiotherapy and Exercise Science
Curtin University
Kent Street
Bentley, WA, 6102
Country [1] 296638 0
Australia
Secondary sponsor category [2] 296660 0
Individual
Name [2] 296660 0
Daniel Gucciardi
Address [2] 296660 0
Building 408, School of Physiotherapy and Exercise Science
Curtin University
Kent Street
Bentley, WA, 6102
Country [2] 296660 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298711 0
Social Sciences Research Review Board, Department of National Defence, Government of Canada
Ethics committee address [1] 298711 0
Ethics committee country [1] 298711 0
Canada
Date submitted for ethics approval [1] 298711 0
Approval date [1] 298711 0
11/09/2016
Ethics approval number [1] 298711 0
#1592-16F

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77982 0
Ms Paige Mattie
Address 77982 0
Mental Performance Manager
Canadian Forces Morale & Welfare Services
Department of National Defence
4210 Labelle St. Ottawa Ontario, K1J 1J7
Canada
Country 77982 0
Canada
Phone 77982 0
+1 613-404-3532
Fax 77982 0
Email 77982 0
[email protected]
Contact person for public queries
Name 77983 0
Daniel Gucciardi
Address 77983 0
School of Physiotherapy and Exercise Science
Curtin University
Kent Street
Bentley, WA, 6102
Country 77983 0
Australia
Phone 77983 0
+61 8 2966 3653
Fax 77983 0
Email 77983 0
[email protected]
Contact person for scientific queries
Name 77984 0
Daniel Gucciardi
Address 77984 0
School of Physiotherapy and Exercise Science
Curtin University
Kent Street
Bentley, WA, 6102
Country 77984 0
Australia
Phone 77984 0
+61 8 2966 3653
Fax 77984 0
Email 77984 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Military personnel data cannot be shared freely.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.