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Trial registered on ANZCTR


Registration number
ACTRN12624001324505
Ethics application status
Approved
Date submitted
9/10/2024
Date registered
31/10/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of digital memory flexibility training (MemFlex) as an adjunct intervention for individuals with post-traumatic stress disorder (PTSD)
Scientific title
A randomised control trial of the effect of digital memory flexibility training (MemFlex) on post-traumatic symptom severity and autobiographical memory in individuals with PTSD
Secondary ID [1] 313103 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic stress disorder 335350 0
Condition category
Condition code
Mental Health 331939 331939 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / 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 PTSD. 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 build upon via eight online self-guided sessions. A 45 minute 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 two online, self-guided sessions (~20 mins) per week for 4 weeks, and can contact the worker with any questions. Treatment adherence is monitored by the support worker through website analytics. The worker will check in with participants each week of the trial. 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. At the end of the MemFlex intervention, participants will crossover into treatment as usual for a 4 week period.
Intervention code [1] 329667 0
Treatment: Other
Comparator / control treatment
Treatment-as-usual only: The control arm of the intervention will involve treatment as usual. This represents current best practice. We will record access to services for each participant. This trial employs a crossover design, meaning all control participants will have access to the MemFlex program after they have completed the baseline and 4-week surveys.
Control group
Active

Outcomes
Primary outcome [1] 339539 0
Post-traumatic stress disorder
Timepoint [1] 339539 0
Baseline (0-weeks), post-intervention (4-weeks) and follow-up (8-weeks)
Primary outcome [2] 339540 0
Autobiographical Memory Flexibility
Timepoint [2] 339540 0
Baseline (0-weeks), post-intervention (4-weeks) and follow-up (8-weeks)
Primary outcome [3] 339541 0
Post-traumatic cognitions
Timepoint [3] 339541 0
Baseline (0-weeks), post-intervention (4-weeks) and follow-up (8-weeks)
Secondary outcome [1] 440386 0
Depression
Timepoint [1] 440386 0
Baseline (0-weeks), post-intervention (4-weeks) and follow-up (8-weeks)
Secondary outcome [2] 440387 0
Anxiety
Timepoint [2] 440387 0
Baseline (0-weeks), post-intervention (4-weeks) and follow-up (8-weeks)
Secondary outcome [3] 440389 0
Trauma Memory Quality
Timepoint [3] 440389 0
Baseline (0-weeks), post-intervention (4-weeks) and follow-up (8-weeks)
Secondary outcome [4] 440390 0
Acceptability
Timepoint [4] 440390 0
Post-intervention (4-weeks; experimental only) and follow-up (8 weeks; control only)
Secondary outcome [5] 440391 0
Feasibility
Timepoint [5] 440391 0
Ongoing for the duration of the trial

Eligibility
Key inclusion criteria
Score of 4 or above on the Primary Care Posttraumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders-5 (PC-PTSD-5)
Proficiency both reading and writing in English
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe 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)
Random allocation to condition using computer-generated, quasi-random numbers. Randomisation will occur on a 1:1 basis to MemFlex or treatment-as-usual.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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. The impact of intervention condition (MemFlex, treatment-as-usual) on post-intervention scores on the Posttraumatic Checklist for DSM-5 will be analysed using an ANOVA, controlling for pre-intervention scores. 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
1/12/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
26/08/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317548 0
University
Name [1] 317548 0
The University of Melbourne
Country [1] 317548 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319853 0
None
Name [1] 319853 0
Address [1] 319853 0
Country [1] 319853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316259 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 316259 0
Ethics committee country [1] 316259 0
Australia
Date submitted for ethics approval [1] 316259 0
27/10/2023
Approval date [1] 316259 0
09/02/2024
Ethics approval number [1] 316259 0

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

Contacts
Principal investigator
Name 137314 0
Dr Caitlin Hitchcock
Address 137314 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 137314 0
Australia
Phone 137314 0
+61425119020
Fax 137314 0
Email 137314 0
caitlin.hitchcock@unimelb.edu.au
Contact person for public queries
Name 137315 0
Caitlin Hitchcock
Address 137315 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 137315 0
Australia
Phone 137315 0
+61425119020
Fax 137315 0
Email 137315 0
caitlin.hitchcock@unimelb.edu.au
Contact person for scientific queries
Name 137316 0
Caitlin Hitchcock
Address 137316 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 137316 0
Australia
Phone 137316 0
+61425119020
Fax 137316 0
Email 137316 0
caitlin.hitchcock@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Outcome measures
When will data be available (start and end dates)?
From the end of the trial, in perpetuity
Available to whom?
Open Science Framework (OSF) users
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Deidentified data will be stored on OSF
Until a data repository is available, Dr Caitlin Hitchcock (caitlin.hitchcock@unimelb.edu.au) can be contacted regarding the IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24263Study protocol    388564-(Uploaded-09-10-2024-14-06-36)-V2 MemFlex Protocol.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.