Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000857303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
1/05/2026
Date registered
Help: Date registered
14/07/2026
Date last updated
Help: Date last updated
14/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
14/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
MemFlex; A Positive, Memory-Based Intervention for Psychological Distress in Rural Australia
Scientific title
A Peer-Led, Memory-Based Intervention for Psychological Distress in Australian Farming Communities: Protocol for a Randomised Controlled Feasibility Trial
Additional trial identifiers [1] 317135 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Depression 341705 0
Posttraumatic Stress 341706 0
Condition category
Condition code
Mental Health 337785 337785 0 0
Depression
Mental Health 337786 337786 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
MemFlex: The MemFlex intervention aims to improve the ability to retrieve any autobiographical memory type on demand, using cued recall exercises. Participants are never asked to retrieve negative memories or trauma memories. In particular, the intervention trains three core skills: balancing, elaboration, and flexibility. Balancing aims to improve access to personally relevant memories that are emotionally positive. Improving ease of access to positive autobiographical information aims to balance against the negative self-appraisals that drive low mood. Elaboration aims to increase the detail and vividness of these positive memories. Flexibility explicitly trains the ability to move between specific and general levels of memory representation. These skills are gradually introduced and built upon via ten online self-guided sessions. A 45-60 minute orientation Zoom call with a facilitator introduces the intervention. Participants are emailed a link to access the online sessions, which involve an initial psychoeducation component, and memory recall exercises using memory cues. In the sessions, participants are trained to recall event memories and general memories, to elaborate memories with contextual, emotional and somatic details, and to flexibly move between memory types. Participants are given access to 10 online, self-guided sessions and encouraged to complete 2-3 sessions (~15 mins) per week for 4-5 weeks, and can contact their facilitator with any questions. Number and frequency of session completion is monitored by the facilitator through website analytics. The facilitator will check in with participants after 2 weeks, then after 4 weeks following orientation. MemFlex participants will be able to continue any other offered activities (e.g., medication, psychological therapy). We will record access to services for each participant. That is, a MemFlex plus care as usual design will be used. As the intervention is entirely online, including contact with the facilitator, participants can access the program when and where they feel comfortable to do so. One week after finishing the post-intervention assessment, participants allocate dot MemFlex will be given Managing Stress on the Farm.
Intervention code [1] 333903 0
Treatment: Other
Intervention code [2] 333904 0
Behaviour
Description of the comparator or control
Managing Stress on the Farm: Participants will receive the Managing Stress on the Farm self-help workbook, which is the standard first-step, low intensity psychosocial intervention used by the community partner, and reflects Care as Usual. The booklet provides information, practical activities (e.g., checklist to measure your awareness of what causes your stress, instructions for perspective taking and positive self-talk exercises, SMART goal setting activity) and links to further resources to support the mental health of farmers, farm workers, farming families and the broader farming community. Participants will be invited to complete the workbook independently, without any formal support, over a five-week period. It is anticipated that it would take approximately 2-3 hours to read through and complete all suggested activities in the 21 page pdf, but completion is self-paced. Participants will continue with their usual daily activities and access any support or services they would ordinarily use. At the end of the five-week period (post-intervention), we will ask participants how many of the workbook materials they engaged with. As this is a crossover design, all participants will then complete the MemFlex program after the five-week period.
Control group
Active

Outcomes
Primary outcome [1] 345236 0
Feasibility of training facilitators
Timepoint [1] 345236 0
End of trial (at completion of post-intervention assessment by the last recruited participant)
Primary outcome [2] 345237 0
Acceptability
Timepoint [2] 345237 0
Post-intervention (5-weeks)
Primary outcome [3] 345238 0
Psychological distress (primary clinical outcome)
Timepoint [3] 345238 0
Post-intervention (5-weeks)
Secondary outcome [1] 461070 0
Autobiographical memory processing (Primary cognitive outcome)
Timepoint [1] 461070 0
Post-intervention (5-weeks)
Secondary outcome [2] 461071 0
Mental wellbeing (secondary clinical outcome)
Timepoint [2] 461071 0
Post-intervention (5-weeks)
Secondary outcome [3] 461072 0
Posttraumatic stress (secondary clinical outcome)
Timepoint [3] 461072 0
Post-intervention (5-weeks)
Secondary outcome [4] 461073 0
Depression (secondary clinical outcome)
Timepoint [4] 461073 0
Post-intervention (5-weeks)
Secondary outcome [5] 461074 0
Negative beliefs (mechanistic outcome)
Timepoint [5] 461074 0
Post-intervention (5-weeks)
Secondary outcome [6] 461075 0
Reward responsivity (mechanistic outcome)
Timepoint [6] 461075 0
Post-intervention (5-weeks)
Secondary outcome [7] 461076 0
Engagement in everyday activities (functional outcome)
Timepoint [7] 461076 0
Post-intervention (5-weeks)
Secondary outcome [8] 461077 0
Maladaptive trauma-related beliefs (secondary mechanistic outcome)
Timepoint [8] 461077 0
Post-intervention (5-weeks)

Eligibility
Key inclusion criteria
Participants (N = 40) will be adults (aged 18 years and above) experiencing psychological distress, recruited from rural areas in Australia, indexed as Modified Monash Model classification of MM2-MM7 (Australian Government Department of Health, 2023). To be included in the trial, participants will score above 24 on the K-10 indicating a moderate level of symptoms (Kessler et al., 2002), be proficient in reading and writing English, and have access to a computer or tablet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Medically confirmed diagnosis of cognitive impairment; or high levels of suicidality or have attempted suicide in the previous two months, as informed by the Suicidal Ideation Attributes Scale (Van Spijker et al., 2014).

Individuals experiencing high levels of suicidality will be referred for more intensive, clinician-delivered support.

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)
Randomisation automatically occurs at the end of the pre-intervention assessment using the in-built randomiser function in Qualtrics
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualtrics inbuilt randomisation sequence, constrained for equal allocation between trial arms
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be completed in accordance with CONSORT guidelines. Our primary outcome of acceptability will be compared between intervention conditions using a Mann-Whitney U test. Descriptive statistics on percentage of eligible participants opting into the study, percentage of participants completing the study, and percentage of trained peer workers who support one or more participants will be summarised to evaluate feasibility of the trial design and procedures. As this is a pilot trial of feasibility, we will be underpowered to detect statistically significant effects on our clinical and cognitive outcomes. The likely effect size for the impact of intervention condition on post-intervention scores on the K-10 will be estimated using analysis of variance (ANOVA), controlling for pre-intervention scores.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2026
Actual
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321720 0
Government body
Name [1] 321720 0
National Health and Medical Research Council
Country [1] 321720 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 324549 0
None
Name [1] 324549 0
Address [1] 324549 0
Country [1] 324549 0
Other collaborator category [1] 283922 0
Other
Name [1] 283922 0
National Centre for Farmer Health
Address [1] 283922 0
Country [1] 283922 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320252 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 320252 0
Ethics committee country [1] 320252 0
Australia
Date submitted for ethics approval [1] 320252 0
18/12/2025
Approval date [1] 320252 0
12/02/2026
Ethics approval number [1] 320252 0
2026-33108-76213-4

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

Contacts
Principal investigator
Name 149898 0
A/Prof Caitlin Hitchcock
Address 149898 0
University of Melbourne, Parkville, VIC, 3070
Country 149898 0
Australia
Phone 149898 0
+61038344 6377
Fax 149898 0
Email 149898 0
[email protected]
Contact person for public queries
Name 149899 0
Kelly Barnes
Address 149899 0
National Centre for Farmer Health, Western Districts Health Service, Hamilton, VIC 3300
Country 149899 0
Australia
Phone 149899 0
+610355518533
Fax 149899 0
Email 149899 0
[email protected]
Contact person for scientific queries
Name 149900 0
Caitlin Hitchcock
Address 149900 0
University of Melbourne, Parkville, VIC, 3070
Country 149900 0
Australia
Phone 149900 0
+61038344 6377
Fax 149900 0
Email 149900 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
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes 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:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Data sharing policies



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.