Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000592347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/04/2026
Date registered
Help: Date registered
12/05/2026
Date last updated
Help: Date last updated
12/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
12/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A memory-based digital intervention (MemFlex) for young people struggling with low mood
Scientific title
A randomised control trial of the effect of digital memory flexibility training (MemFlex) on depressive symptoms in young people
Additional trial identifiers [1] 316634 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Depression 340841 0
Condition category
Condition code
Mental Health 337001 337001 0 0
Depression

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 depression. 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 minute orientation Zoom call with a support worker 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 encouraged to complete 2-3 online, self-guided sessions (~15 mins) per week for 4 weeks, and can contact their support worker via email or phone number with any questions. Treatment adherence is monitored by the support worker through website analytics. The support worker will check in with participants after 2 weeks, then after 4 weeks following orientation, by either email, text message, or phone call depending on participant preference. 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 treatment as usual design will be used. As the intervention is entirely online, including contact with the support worker, participants can access the program when and where they feel comfortable to do so. After completing the final survey, participants will be offered access to the BrightMind program.
Intervention code [1] 333313 0
Treatment: Other
Description of the comparator or control
BrightMind: BrightMind is a psychoeducation-based online program which has been created for the purposes of this trial by the research team. The program content is closely based on the psychoeducation material commonly provided by psychology services, in an effort to create a rigorous comparison condition which is representative of current low-intensity options. The BrightMind intervention aims to provide participants with psychoeducation on factors which affect depression. Participants will complete ten online self-guided sessions. Sessions cover sleep hygiene, worry, procrastination, assertive communication, anger, perfectionism, diet and exercise. These factors have been selected as they commonly perpetuate depression, and tend to be addressed during CBT. A 45 minute orientation Zoom call introduces the intervention. Participants are emailed a link to access the online sessions, which includes an initial session that revises information introduced during orientation. Each session includes a question asking participants to respond to a hypothetical scenario of someone struggling with depression to ensure participant engagement, and an exercise requiring the individual to reflect on the role of that factor in their own lives, and on how they could use the suggested techniques. Participants are encouraged to complete 2-3 online, self-guided sessions (~15 mins) per week for 4 weeks, and can contact their support worker via email or phone call with any questions. Treatment adherence is monitored by the support worker through website analytics. The support worker will check in with participants after 2 weeks, then after 4 weeks following orientation, via email, text message, or phone call depending on the participant's preference. BrightMind 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 BrightMind plus treatment as usual design will be used. As the intervention is entirely online, including contact with the support worker, participants can access the program when and where they feel comfortable to do so. BrightMind participants will be offered access to the MemFlex program after completing the final survey.
Control group
Active

Outcomes
Primary outcome [1] 344527 0
Acceptability - primary measure of outcome
Timepoint [1] 344527 0
Post-intervention (5-weeks)
Primary outcome [2] 344528 0
Feasibility
Timepoint [2] 344528 0
Ongoing for the duration of the trial
Primary outcome [3] 345206 0
Depressive symptoms
Timepoint [3] 345206 0
Baseline (0-weeks), post-intervention (5-weeks) and follow-up (10-weeks)
Secondary outcome [1] 458197 0
Acceptability - secondary measure of outcome
Timepoint [1] 458197 0
Pre-intervention (0-weeks) and post-intervention (5-weeks)
Secondary outcome [2] 458198 0
Autobiographical Memory Flexibility
Timepoint [2] 458198 0
Baseline (0-weeks), post-intervention (5-weeks) and follow-up (10-weeks)
Secondary outcome [3] 458199 0
Diagnosis of depression
Timepoint [3] 458199 0
Baseline (0-weeks), post-intervention (5-weeks) and follow-up (10-weeks)
Secondary outcome [4] 458202 0
Mental Wellbeing
Timepoint [4] 458202 0
Baseline (0-weeks), post-intervention (5-weeks) and follow-up (10-weeks)
Secondary outcome [5] 458203 0
Exploratory: Functioning
Timepoint [5] 458203 0
Baseline (0-weeks), post-intervention (5-weeks) and follow-up (10-weeks)
Secondary outcome [6] 458205 0
Exploratory: Approach tendencies
Timepoint [6] 458205 0
Baseline (0-weeks), post-intervention (5-weeks) and follow-up (10-weeks)
Secondary outcome [7] 460912 0
Exploratory: Anxiety
Timepoint [7] 460912 0
Baseline (0-weeks), post-intervention (5-weeks) and follow-up (10-weeks)
Secondary outcome [8] 461229 0
Exploratory outcome: Reward responsivity in social situations
Timepoint [8] 461229 0
Baseline (0-weeks) and post-intervention (5-weeks)

Eligibility
Key inclusion criteria
Score of 10 or above on the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2003), proficiency in reading and writing English, and have access to a computer.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Have a medically confirmed diagnosis of cognitive impairment.

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)
Allocation is completed by a researcher blinded to the randomisation seqeuence. Randomisation automatically occur at the end of the baseline survey using the in-built randomiser function in Qualtrics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation automatically occurs at the end of the baseline survey using the in-built randomiser function in Qualtrics. Randomisation will occur on a 1:1 basis to MemFlex or BrightMind.
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
All analyses will be completed in accordance with CONSORT guidelines. The impact of intervention condition (MemFlex, BrightMind) on post-intervention scores on the PHQ-9 will be analysed using an ANOVA, controlling for pre-intervention scores. Acceptability using 5 star rating at post-intervention will be compared between intervention conditions using a Mann-Whitney U test. Statistics on percentage of eligible participants opting into the study, and percentage of participants completing the study, will also be analysed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/05/2026
Actual
Date of last participant enrolment
Anticipated
1/12/2027
Actual
Date of last data collection
Anticipated
26/01/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 321251 0
University
Name [1] 321251 0
The University of Melbourne
Country [1] 321251 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 323962 0
None
Name [1] 323962 0
Address [1] 323962 0
Country [1] 323962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319778 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 319778 0
Ethics committee country [1] 319778 0
Australia
Date submitted for ethics approval [1] 319778 0
10/12/2025
Approval date [1] 319778 0
22/04/2026
Ethics approval number [1] 319778 0
2026-34818-79148-4

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

Contacts
Principal investigator
Name 148370 0
A/Prof Caitlin Hitchcock
Address 148370 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 148370 0
Australia
Phone 148370 0
+61 3 9035 3847
Fax 148370 0
Email 148370 0
[email protected]
Contact person for public queries
Name 148371 0
Caitlin Hitchcock
Address 148371 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 148371 0
Australia
Phone 148371 0
+61 3 9035 3847
Fax 148371 0
Email 148371 0
[email protected]
Contact person for scientific queries
Name 148372 0
Caitlin Hitchcock
Address 148372 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 148372 0
Australia
Phone 148372 0
+61 3 9035 3847
Fax 148372 0
Email 148372 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:
• Open Science Framework (OSF) users

Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
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:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Deidentified data will be stored on OSF
Until a data repository is available, Dr Caitlin Hitchcock ([email protected]) can be contacted regarding the IPD.

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol2026   MemFlex_YouthDigital_Protocol_V5.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.