Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001669886
Ethics application status
Approved
Date submitted
1/11/2021
Date registered
3/12/2021
Date last updated
21/04/2024
Date data sharing statement initially provided
3/12/2021
Date results provided
21/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of the Men in Mind Training for Mental Health Practitioners
Scientific title
A Randomised Controlled Trial of the Efficacy of the Men in Mind Training on Mental Health Practitioners' Clinical Competencies for Working with Male Clients
Secondary ID [1] 304994 0
MRF1199972
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health practitioners' clinical competencies for working with male clients 323147 0
Condition category
Condition code
Mental Health 320721 320721 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 321884 321884 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an online training program designed specifically for this study. The training, entitled ‘Men in Mind’, is designed for mental health practitioners working with men. Since men engage in psychological treatment at lower rates than women, the goal of the training is to increase clinicians’ competence and confidence in providing psychological treatment to male clients.

Participants assigned to the intervention group will be provided access to the training for a period of six (6) weeks. The training is conducted entirely online, in a self-paced format, and is estimated to take 8 hours to complete. The training program consists of five modules comprising content such as: male client and clinician gender socialisation and the interaction between these in practice; engagement and motivation strategies for male clients; and identifying and responding effectively to male distress and suicidality in counselling.

Each of the five modules contains a mix of text- and video-based content delivery (41 videos across the course), presented alongside engaging imagery throughout. A number of learning design tools have been included in the training program to facilitate engagement and participants’ learning. Furthermore, the trial design includes regular communication with participants in order to encourage engagement and improve adherence.
Intervention code [1] 321382 0
Behaviour
Comparator / control treatment
The comparator will be a waitlist control condition of six (6) weeks' duration. Participants in the waitlist control group will not receive any training during the six-week control period.
Control group
Active

Outcomes
Primary outcome [1] 328544 0
The difference between intervention and control groups in mean pre–post (T1–T2) changes in self-reported clinical competencies for working with male clients, as measured by scores on the Engaging Men in Therapy Scale (EMITS)
Timepoint [1] 328544 0
Immediately post-intervention completion (T2)
Secondary outcome [1] 399508 0
The difference between intervention and control groups in mean pre–post (T1–T2) changes in self-efficacy, as measured by scores on the Counsellor Self-Efficacy Scale (COSE)
Timepoint [1] 399508 0
Immediately post-intervention completion (T2)
Secondary outcome [2] 399509 0
The difference between intervention and control groups in mean pre–post (T1–T2) changes in therapist competency and clinical skills, as measured by scores on the Development of Psychotherapists Common Core Questionnaire (DPCCQ)
Timepoint [2] 399509 0
Immediately post-intervention completion (T2)
Secondary outcome [3] 399513 0
Within the intervention group, changes in mean EMITS scores from pre-intervention to follow-up (T1–T3) and from post-intervention to follow-up (T2–T3)
Timepoint [3] 399513 0
Follow-up at 12 weeks post-intervention completion (T3)
Secondary outcome [4] 399515 0
Within the control group, changes in mean EMITS scores from post-waitlist (T2) to follow-up (T3)
Timepoint [4] 399515 0
Follow-up at 6 weeks post-intervention completion (T3)

Eligibility
Key inclusion criteria
Mental health practitioner working in Australia;
Currently administering psychotherapy to male clients, either in person or via telehealth;
Fluent in English; AND
Provides informed consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Undergraduate student;
Not currently administering psychotherapy to male clients;
Not fluent in English; OR
Does not consent to participate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation schedule will be created by the study statistician and transferred to the data management company, unseen by the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with stratification by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The recruitment target has been set at 380 participants. This number will allow detection of a small-to-medium size effect (Cohen’s d=0.4) with 90% power and alpha 0.05, conservatively assuming a correlation between pre- and post-training scores of 0.5. This sample size allows for up to 30% attrition at T2 (primary endpoint).

Analyses will be undertaken on an intention-to-treat basis and will include all participants in the group to which they were randomised (regardless of actual receipt or uptake of the intervention or withdrawal from the study). Mixed-model repeated measures analyses will be used because of the ability of this approach to include participants with missing data. The model will include factors of study condition (intervention or control group), occasion of measurement (T1, T2 and T3), and their interaction. Analyses will include the effect of the stratification variable, gender, with associated model parameters being retained if they are statistically significant.

The primary outcome will be assessed by a planned comparison of the difference between groups in change of the primary outcome variable (EMITS) from T1 to T2. This test will be undertaken with an alpha of .05. An unstructured residual variance-covariance matrix will accommodate within-participant dependency. Tests of significance will use appropriate degrees of freedom adjustment where necessary (e.g., the Kenward-Roger method based on the observed information matrix). Where necessary, transformation of the outcome variable will be undertaken to ensure distributional assumptions of the model are met.

Analyses of secondary outcome variables (DPCCQ and COSE subscales) will follow the same methods as the primary outcome. These analyses will be subject to appropriate adjustment for multiple testing. Secondary outcomes will also include change in the primary and other outcome variables from baseline (T1) to follow-up (T3) to inform the outcome pertaining to retention of learning. (Note that change in the intervention group over this period cannot be compared to the waitlist as the latter group will be provided with access to the intervention after T2.) The magnitude of change within both active and control groups from T2 to T3 will be also estimated to reflect retention of learning. T3 outcomes in the waitlist group will be compared to their T2 scores in order to estimate change in this group after they have accessed the training program. The extent of change will be contrasted to T1-T2 change attributable to the training program in the intervention group. Subject to qualifications arising due to attrition and natural drift over time, these analyses will stand as a quasi-replication of the primary outcome of the trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2022
Actual
16/01/2022
Date of last participant enrolment
Anticipated
Actual
17/03/2022
Date of last data collection
Anticipated
Actual
9/06/2022
Sample size
Target
380
Accrual to date
Final
587
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309378 0
Government body
Name [1] 309378 0
Australian Government Department of Health
Country [1] 309378 0
Australia
Funding source category [2] 309406 0
Charities/Societies/Foundations
Name [2] 309406 0
Movember
Country [2] 309406 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen
Address
Orygen
35 Poplar Road
Parkville VIC 3052
Australia
Country
Australia
Secondary sponsor category [1] 310351 0
None
Name [1] 310351 0
Address [1] 310351 0
Country [1] 310351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309194 0
University of Melbourne Faculty of Medicine, Dentistry and Health Sciences (MDHS) Human Research Ethics Committee
Ethics committee address [1] 309194 0
Ethics committee country [1] 309194 0
Australia
Date submitted for ethics approval [1] 309194 0
15/09/2021
Approval date [1] 309194 0
29/10/2021
Ethics approval number [1] 309194 0
22618

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

Contacts
Principal investigator
Name 113302 0
Dr Zac Seidler
Address 113302 0
Orygen
35 Poplar Road
Parkville VIC 3052
Country 113302 0
Australia
Phone 113302 0
+61435120926
Fax 113302 0
Email 113302 0
[email protected]
Contact person for public queries
Name 113303 0
Zac Seidler
Address 113303 0
Orygen
35 Poplar Road
Parkville VIC 3052
Country 113303 0
Australia
Phone 113303 0
+61435120926
Fax 113303 0
Email 113303 0
[email protected]
Contact person for scientific queries
Name 113304 0
Zac Seidler
Address 113304 0
Orygen
35 Poplar Road
Parkville VIC 3052
Country 113304 0
Australia
Phone 113304 0
+61435120926
Fax 113304 0
Email 113304 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual quantitative participant data collected during the trial underlying published results.
When will data be available (start and end dates)?
Following publication of primary results; no end date determined.
Available to whom?
Researchers who provide a methodologically sound proposal and who have ethics approval from a research institution. This will be determined on a case-by-case basis at the discretion of the Primary Sponsor and Principal Investigator
Available for what types of analyses?
All.
How or where can data be obtained?
The data will be stored on the servers of Orygen. Access will be subject to approvals by the Principal Investigator, Dr. Zac Seidler ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12842Ethical approval    382561-(Uploaded-01-11-2021-10-17-50)-Study-related document.pdf
13880Informed consent form    382561-(Uploaded-01-11-2021-11-50-55)-Study-related document.docx



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.