Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001377325
Ethics application status
Approved
Date submitted
18/09/2017
Date registered
28/09/2017
Date last updated
6/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of resilience training in the military
Scientific title
Examining the role of systematic coping reflection on enhancing resilience in Officer Cadets
Secondary ID [1] 292907 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 304755 0
Anxiety 304756 0
Adaptive stressor appraisal 304757 0
perceived stress 304758 0
subjective wellbeing 304759 0
Condition category
Condition code
Mental Health 304081 304081 0 0
Depression
Mental Health 304082 304082 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will use a clustered randomised controlled trial to determine the efficacy of the Mental Fitness Training program. Assignment to one of the two intervention conditions will be randomised by platoon, which is a common practice in military training evaluations in order to avoid cross-contamination of training content.

Of the seven platoons commencing second-class Royal Military College in January 2018, three platoons will receive the BattleSMART program (40 minutes) and exercises relevant to Royal Military College training (75 minutes). The remaining four platoons will receive the Mental Fitness Training.

After the initial 40-minute Mental Fitness Training, Cadets will complete a coping self-reflection activity weekly for five weeks as part of a workbook. In the Mental Fitness Training group, this will consist of questions asking Cadets to reflect on and critically examine their approaches to coping with the stressors they have encountered in the previous week.

The BattleSMART program was developed to build the resilience of military ADF personnel and includes the teaching of several cognitive-behavioural skills designed to enhance adaptive coping in personnel. All Cadets receive the BattleSMART program in third-class (initial 6 months) within Royal Military College. In this way, all Cadets involved in the study had previously received the BattleSMART program 6 months prior. Typically, Cadets in second class receive the BattleSMART program again. For the purpose of this study, the BattleSMART program will be replaced with the Mental Fitness Training in second-class for four platoons. The other three platoons will received the 40 minute BattleSMART program and communication skills training to balance the dose experienced by each group (e.g., contact time).

Both intervention programs will be delivered by psychologists from the Royal Military College. These psychologists have considerable years experience working with Army soldiers and the delivery of resilience training in the military context. The lead Mental Fitness Training developer will provide oversight and guidance regarding the administration of the Mental Fitness Training.

Cadets will be asked to complete three surveys: (1) at baseline (prior to the intervention), an initial post-training survey, and a long-term follow-up survey. Immediately after survey completion, Cadets will be asked to review their responses and edit if they feel necessary before sealing the envelopes provided. The long-term follow-up survey will occur just over three months from the completion of the Mental Fitness Training. Dates for administration will be decided upon in negotiation with Royal Military College instructional staff. All surveys will be completed using pen and paper.

All interventions and surveys take place at the Royal Military College in a large lecture theatre.

The Mental Fitness Training was developed in collaboration with Army psychologists and the lead second-class instructor from Royal Military College over a 12-month period. Mental Fitness Training was intended to strengthen Cadet psychological resilience using a guided coping self-reflection tool. Cadets in the Mental Fitness Training group received a 40-minute brief about the training program. This initial brief covered: (1) understanding how the experience of stressors can strengthen resilience, tolerance and performance, (2) understanding where mental-fitness plays a role in performance, (3) how reflecting on stressors and setbacks in one’s life can enhance resilience, (4) identification of leadership values in relation to coping under pressure, and (5) how to complete the questions in the workbook. Each week during the five weeks following the initial brief, Cadets complete a 15-minute guided self-reflection writing task in a workbook. The purpose of this task is to help the Cadets reflect on their stressor experiences, develop an awareness of their approaches to coping, consider the effectiveness of these strategies, and improve the application of coping for the future. To achieve this goal, the workbook required Cadets to address the same series of reflective questions for the initial three-weeks. On the fourth week, similar questions are used to examine the behaviour of others and in the final week Cadets read back over their reflections to understand their own pattern of coping.
Intervention code [1] 299137 0
Prevention
Comparator / control treatment
Cadets in the control group will receive treatment as usual which is the resilience training currently used by Army. This is the BattleSMART program which is a 40-minute presentation used to teach psychoeducation and practice of key coping skills.
Control group
Active

Outcomes
Primary outcome [1] 303399 0
Anxiety. The Generalized Anxiety Disorder 7-Item (GAD-7) Questionnaire contains 7-items designed to measure symptoms of anxiety and anxiety severity. The GAD-7 has been demonstrated to have good psychometric properties (Lowe, et al., 2008).
Timepoint [1] 303399 0
There are four time points: baseline, at the end of the Mental Fitness Training or communication skills training (initial follow-up), 3-month follow-up and 5 month follow-up. The three and four month follow-up are our primary time points of interest.

Note: the control group will receive the 40 minute BattleSMART program (cognitive and behavioural coping skills) and 75 minutes of communication skills training to balance the dose experienced by each group (e.g., contact time). Thus, there was a total of four time points. This time point was not planned for as part of the original submission.
Primary outcome [2] 303400 0
Depression. The Patient Health Questionnaire – 9 items (PHQ-9) will be used to examine the presence of current depression symptoms and their severity in Cadets at all three time points (Kroenke, et al., 2009 ).
Timepoint [2] 303400 0
There are four time points: baseline, at the end of the Mental Fitness Training or communication skills training (initial follow-up), 3-month follow-up and 5 month follow-up. The three and four month follow-up are our primary time points of interest.

Note: the control group will receive the 40 minute BattleSMART program (cognitive and behavioural coping skills) and 75 minutes of communication skills training to balance the dose experienced by each group (e.g., contact time). Thus, there was a total of four time points. This time point was not planned for as part of the original submission.
Primary outcome [3] 303401 0
Perceived stress. The perceived Stress Scale (PSS: Cohen, Kamarck, & Mermelstein, 1983) is a classic stress assessment instrument.
Timepoint [3] 303401 0
There are four time points: baseline, at the end of the Mental Fitness Training or communication skills training (initial follow-up), 3-month follow-up and 5 month follow-up. The three and four month follow-up are our primary time points of interest.

Note: the control group will receive the 40 minute BattleSMART program (cognitive and behavioural coping skills) and 75 minutes of communication skills training to balance the dose experienced by each group (e.g., contact time). Thus, there was a total of four time points. This time point was not planned for as part of the original submission.
Secondary outcome [1] 338835 0
Stressor appraisal. Cadets will be asked to indicate for each training stressor the degree to which they consider these stressors to be threatening or challenging. This tool is designed specifically for use in this study.
Timepoint [1] 338835 0
There are four time points: baseline, at the end of the Mental Fitness Training or communication skills training (initial follow-up), 3-month follow-up and 5 month follow-up. The three and four month follow-up are our primary time points of interest.

Note: the control group will receive the 40 minute BattleSMART program (cognitive and behavioural coping skills) and 75 minutes of communication skills training to balance the dose experienced by each group (e.g., contact time). Thus, there was a total of four time points. This time point was not planned for as part of the original submission.
Secondary outcome [2] 338836 0
Perceived frequency of training stressors. This measure is intended to capture the frequency of stressors relevant to the RMC training context. This list was created in collaboration with an Army psychologist familiar with the training stressors at RMC and an RMC training instructor. There are 23 stressors in this list (e.g., physical demands) and Cadets are asked to indicate how often this stressor occurred in the past week.
Timepoint [2] 338836 0
There are four time points: baseline, at the end of the Mental Fitness Training or communication skills training (initial follow-up), 3-month follow-up and 5 month follow-up. The three and four month follow-up are our primary time points of interest.

Note: the control group will receive the 40 minute BattleSMART program (cognitive and behavioural coping skills) and 75 minutes of communication skills training to balance the dose experienced by each group (e.g., contact time). Thus, there was a total of four time points. This time point was not planned for as part of the original submission.
Secondary outcome [3] 338837 0
Coping self-efficacy. Coping self-efficacy (CSE; Chesney, Chambers, Taylor, Johnson, & Folkman, 2003),
Timepoint [3] 338837 0
There are four time points: baseline, at the end of the Mental Fitness Training or communication skills training (initial follow-up), 3-month follow-up and 5 month follow-up. The three and four month follow-up are our primary time points of interest.

Note: the control group will receive the 40 minute BattleSMART program (cognitive and behavioural coping skills) and 75 minutes of communication skills training to balance the dose experienced by each group (e.g., contact time). Thus, there was a total of four time points. This time point was not planned for as part of the original submission.
Secondary outcome [4] 338838 0
Professional support seeking. Cadet’s will be asked to indicate at longer-term follow-up whether they have sought support from the student counsellor or Chaplin over the course of their second-class training.
Timepoint [4] 338838 0
There are four time points: baseline, at the end of the Mental Fitness Training or communication skills training (initial follow-up), 3-month follow-up and 5 month follow-up. The three and four month follow-up are our primary time points of interest.

Note: the control group will receive the 40 minute BattleSMART program (cognitive and behavioural coping skills) and 75 minutes of communication skills training to balance the dose experienced by each group (e.g., contact time). Thus, there was a total of four time points. This time point was not planned for as part of the original submission.
Secondary outcome [5] 338839 0
Objective performance. During training at the Royal Military College Cadets are assessed on their physical fitness, assignment activities, and performance in the field. Physical fitness is assessed via standardised assessment of physical capability. Assignments relate to learnt material that is assessed by training instructors via standardised tasks. Performance in the field relates to instruct observations of the Cadet's capacity to lead confidently, navigate in the field, respond to changing situations and achieve the mission objectives. Performance on these activities comprise a total raw score relating Cadets' overall performance.
Cadets' raw performance scores for Cadets who provided consent for the researchers to obtain this information. This will allow an objective measure of performance and will enable us to determine whether the mental fitness training is affecting performance outcomes when comparing the control group to the intervention group.
Timepoint [5] 338839 0
This measure will be collected at the end of training.

Eligibility
Key inclusion criteria
Commencing second class in January 2018 at the Royal Military College
Minimum age
18 Years
Maximum age
44 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participants will be approximately 250 Royal Military College second-class Cadets. Based on previous studies the demographic make-up of this group is approximately: 20% females; 80% males, on average, the Cadets are 22 years old (ranging from 18 to 44), and have served in Army for an average of 2.4 years (ranging from 6 months to 11 years). It is essential that both genders and a range of ages and experience are represented in the study. The study design attempts to enable this by asking participants to participate in the evaluation of the mental fitness training evaluation at the same time training is being administered.

All analyses will be conducted using SPSS version 22. Power calculations have been conducted to confirm that given the plausible sample size the study is powered to detect absolute differences in the primary outcomes. Power analyses were conducted using “longpower” in R.

Generalised estimation equation (GEE) modelling technique will be used to model and examine changes in the marginal means for each outcome and intervention group over time. GEE emphasises the modelling of change in an average group effect over time while accounting for within-subject variance with the specification of a working correlation structure. Rather than creating conditional interpretation with the use of individual intercepts or random slopes, as in traditional mixed linear models, the primary emphasis in GEE is to model the average group-related change over time (Hubbard, et al., 2010).

SPSS pairwise comparisons will be used to explore and understand any significant main and interaction effects observed in the GEE analyses. Cohens d effect sizes and 95% CIs will also be calculated for the within-group and between-group effects based on the estimated marginal mean values derived from the GEE models.

We will also be performing an analysis of clinical change for the PHQ (depression) measure and the GAD (anxiety) measure.

To address missing values data, replacement values will be generated for all dependent variables following an analysis of missing values assumptions (Little, et al., 2012).


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/01/2018
Actual
22/01/2018
Date of last participant enrolment
Anticipated
23/01/2018
Actual
23/01/2018
Date of last data collection
Anticipated
31/07/2018
Actual
6/08/2018
Sample size
Target
250
Accrual to date
Final
218
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 297537 0
University
Name [1] 297537 0
Macquarie University
Country [1] 297537 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Building C3A, Department of Psychology
Macquarie University
North Ryde, NSW, 2109
Country
Australia
Secondary sponsor category [1] 296545 0
Government body
Name [1] 296545 0
Royal Military College
Address [1] 296545 0
Cnr Harrison Rd and Robert Campbell Rd

Campbell, ACT, 2612
Country [1] 296545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298632 0
The Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC)
Ethics committee address [1] 298632 0
Ethics committee country [1] 298632 0
Australia
Date submitted for ethics approval [1] 298632 0
16/10/2017
Approval date [1] 298632 0
05/12/2017
Ethics approval number [1] 298632 0
015-17
Ethics committee name [2] 298633 0
Macquarie University Human Research Ethics Committee
Ethics committee address [2] 298633 0
Ethics committee country [2] 298633 0
Australia
Date submitted for ethics approval [2] 298633 0
27/11/2017
Approval date [2] 298633 0
Ethics approval number [2] 298633 0

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

Contacts
Principal investigator
Name 77714 0
Dr Monique Frances Crane
Address 77714 0
Building C3A, Department of Psychology
Macquarie University, North Ryde, NSW, 2109
Country 77714 0
Australia
Phone 77714 0
+61 2 9850 8604
Fax 77714 0
Email 77714 0
[email protected]
Contact person for public queries
Name 77715 0
Monique Frances Crane
Address 77715 0
Building C3A, Department of Psychology
Macquarie University, North Ryde, NSW, 2109
Country 77715 0
Australia
Phone 77715 0
+61 2 9850 8604
Fax 77715 0
Email 77715 0
[email protected]
Contact person for scientific queries
Name 77716 0
Monique Frances Crane
Address 77716 0
Building C3A, Department of Psychology
Macquarie University, North Ryde, NSW, 2109
Country 77716 0
Australia
Phone 77716 0
+61 2 9850 8604
Fax 77716 0
Email 77716 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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