Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000947404
Ethics application status
Approved
Date submitted
14/08/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and Evaluation of a Mental Health Podcast for Men: A Pilot Study
Scientific title
Feasibility and Preliminary Efficacy of a Mental Health Podcast for Men: A Pilot Study
Secondary ID [1] 314854 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Distress 338128 0
Condition category
Condition code
Mental Health 334413 334413 0 0
Anxiety
Mental Health 334414 334414 0 0
Depression
Mental Health 334415 334415 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Podcast condition

- Intervention description and dose:
Participants in the 'podcast' condition will receive 12-episodes of a researcher developed podcast that has been specifically gender-tailored for men. Based on formative research, it will include episodes relating to mental health literacy (e.g., masculinity and mental health, recognising signs and symptoms), coping skills (e.g., evidence based advice for increasing physical activity), substance use and addiction (e.g., stories of recovery from alcohol and drug addiction), psychological skills (e.g., cognitive flexibility, acceptance), connection and relationships (e.g., fathering, loneliness), and environmental factors (e.g., work pressure and burnout).

a) duration of each episode of the podcast: 45-60 minutes.
b) total duration of the intervention: 10 weeks.
c) episode frequency: participants will receive episodes 1-3 in week 1, then one episode per week from weeks 2 to 10.


Mode: Online.

Procedures:
- Baseline: After completing the pre-test questionnaire at baseline, participants will receive instructions on how to access their individual RSS feed to access the private podcast. In addition, a text message reminder will be sent the day each new episode is released.

Materials: Participants will need to own a smart phone, computer or tablet with internet access to access the podcast episodes.

Location: Online.

Treatment adherence: Participant compliance (listenership) will be collected via podcast analytics data.
Intervention code [1] 331458 0
Treatment: Other
Comparator / control treatment
Arm 2: Waitlist condition (no treatment given during intervention period)

- Intervention description and dose: participants randomised to the waitlist control condition will receive the podcast receive access to the podcast intervention after the study has concluded and they have completed the post-baseline questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 342113 0
Outcome: Participant podcast listenership.
Timepoint [1] 342113 0
Post-intervention (10-weeks post baseline).
Primary outcome [2] 342114 0
Outcome: Podcast satisfaction
Timepoint [2] 342114 0
Post-intervention (10-weeks post-baseline)
Primary outcome [3] 342115 0
Outcome: Participant retention
Timepoint [3] 342115 0
Post-intervention (10-weeks post-baseline)
Secondary outcome [1] 449595 0
Feasibility outcome: Recruitment capability
Timepoint [1] 449595 0
Assessed at the conclusion of the recruitment period.
Secondary outcome [2] 449596 0
Outcome: Change in depressive symptoms.
Timepoint [2] 449596 0
Baseline and post-intervention (10-weeks post-baseline)
Secondary outcome [3] 449597 0
Outcome: Change in anxiety symptoms.
Timepoint [3] 449597 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [4] 449598 0
Outcome: Change in stress symptoms.
Timepoint [4] 449598 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [5] 449599 0
Outcome: Change in overall negative emotional state.
Timepoint [5] 449599 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [6] 449674 0
Outcome: Change in mental well-being
Timepoint [6] 449674 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [7] 449675 0
Outcome: Change in emotional control score
Timepoint [7] 449675 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [8] 449676 0
Outcome: Change in self-reliance score
Timepoint [8] 449676 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [9] 449677 0
Outcome: Individual's tendency to seek psychological professional help score
Timepoint [9] 449677 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [10] 449680 0
Outcome: Change in perceived mental health stigma score
Timepoint [10] 449680 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [11] 450902 0
Outcome: Change in loneliness score
Timepoint [11] 450902 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [12] 450903 0
Outcome: Change in mental health self-efficacy
Timepoint [12] 450903 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [13] 450905 0
Outcome: Change in physical activity
Timepoint [13] 450905 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [14] 450906 0
Outcome: Change in risky alcohol consumption
Timepoint [14] 450906 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [15] 450908 0
Outcome: Change in male depression score
Timepoint [15] 450908 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [16] 450909 0
Outcome: Change in behavioral activation score
Timepoint [16] 450909 0
Baseline, and post-intervention (10-weeks post-baseline)
Secondary outcome [17] 450987 0
Outcome: Change in sleep quality
Timepoint [17] 450987 0
Baseline, post-intervention (10-weeks post-baseline)
Secondary outcome [18] 450989 0
Outcome: Change in coping-related substance use
Timepoint [18] 450989 0
Baseline, and post-intervention (10-weeks post-baseline)

Eligibility
Key inclusion criteria
- Identify as men.
- Aged 18-70 years.
- Reports at least mild depression, anxiety or stress in past week based on Depression, Anxiety Stress Scale [DASS-21], cut-points: mild depression =5, mild anxiety =4, mild stress =8).
- Own a computer or smart device with internet access.
- Have a current email address and mobile phone number.
- Able to understand, speak, read and write in English.
- Willing to participate in their assigned treatment group for the duration of the study period.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Person required immediate intensive treatment or hospitalisation, as determined by the study psychologist (e.g., acute suicide risk).
- Have started receiving psychological therapy or counselling in the past 4-weeks.
- Have started a new medication or changed medication dose in the last 4-weeks.
- Unable to speak, read or understand English.
- No access to an internet connected smart-phone, tablet or computer to listen to podcasts and complete surveys.
- Not willing to be randomly allocated into either study group.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After participants have completed the baseline survey, an independent research assistant (not associated with the trial) will access the Sealed Envelope TM simple randomisation service using a secured trial password to allocate participants to one of the two study groups. Allocation will occur in real-time as the research assistant enters the participant's ID into the system. The randomisation result is displayed immediately on-screen and emailed to both the trial chief investigator and the research assistant performing the randomisation, ensuring transparency and record-keeping. After randomisation, the participant will be emailed details of their group assignment, including instructions on how to access the podcast where appropriate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence is generated by Sealed Envelope TM using computer-generated random permuted blocks. There is a 1:1 random allocation ratio within each block. Block sizes are randomly varied to prevent predictability. This blocked randomisation approach ensures approximately equal numbers of participants in each treatment group over time while maintaining allocation concealment.
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
Statistical methods / analysis
Sample size: A sample size calculation is not required for pilots, but we will recruit 30 participants to provide stable estimates of retention, satisfaction, and preliminary efficacy. This sample also aligns with Whitehead et al's (2016) recommendation to recruit 15 participants per condition in pilot trials of future RCTs that will aim to detect a medium effect size between groups (90% power, two-sided test, p<0.05).

Analyses: Descriptive analyses will assess feasibility outcomes. Intention-to-treat linear mixed models will identify the preliminary impact on key efficacy outcomes. As the trial is not specifically powered to detect changes in efficacy-related outcomes, the interpretation of results will focus on the overall group-by-time effect size (cohen's d) rather than indicators of statistical significance.

Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016;25:1057-73. doi:10.1177/0962280215588241 pmid:26092476.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
22/12/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319412 0
University
Name [1] 319412 0
University of Newcastle, Australia
Country [1] 319412 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 321897 0
None
Name [1] 321897 0
Address [1] 321897 0
Country [1] 321897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317983 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 317983 0
Ethics committee country [1] 317983 0
Australia
Date submitted for ethics approval [1] 317983 0
22/07/2024
Approval date [1] 317983 0
23/01/2025
Ethics approval number [1] 317983 0
H-2024-0274

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

Contacts
Principal investigator
Name 142774 0
A/Prof Myles Young
Address 142774 0
The School of Psychological Sciences, University of Newcastle, University Dr, Callaghan NSW 2308
Country 142774 0
Australia
Phone 142774 0
+6124921 6096
Fax 142774 0
Email 142774 0
[email protected]
Contact person for public queries
Name 142775 0
Myles Young
Address 142775 0
The School of Psychological Sciences, University of Newcastle, University Dr, Callaghan NSW 2308
Country 142775 0
Australia
Phone 142775 0
+6124921 6096
Fax 142775 0
Email 142775 0
[email protected]
Contact person for scientific queries
Name 142776 0
Myles Young
Address 142776 0
The School of Psychological Sciences, University of Newcastle, University Dr, Callaghan NSW 2308
Country 142776 0
Australia
Phone 142776 0
+6124921 6096
Fax 142776 0
Email 142776 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email first, Elizabeth Dascombe or senior author, Dr Myles Young in primary outcomes paper.
First author: [email protected]
Senior Author: Myles. [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    BC04 Expedited Approval.pdf


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.