Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000566538
Ethics application status
Approved
Date submitted
22/04/2024
Date registered
6/05/2024
Date last updated
5/07/2024
Date data sharing statement initially provided
6/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of digital memory flexibility training (MemFlex) as a stepped care intervention for individuals with post-traumatic stress disorder (PTSD)
Scientific title
A randomised control trial of the effect of digital memory flexibility training (MemFlex) as a stepped care intervention on post-traumatic symptom severity and autobiographical memory in individuals with PTSD
Secondary ID [1] 311980 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 333592 0
Condition category
Condition code
Mental Health 330274 330274 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 also check in with participants 2 weeks into the trial. MemFlex participants will be able to continue any other offered activities (e.g., medication). That is, a MemFlex+ treatment as usual (in this case, waitlist for psychiatry services at Phoenix Australia) design will be used.
Intervention code [1] 328439 0
Treatment: Other
Comparator / control treatment
Waitlist as usual: The control arm of the intervention will remain on the waitlist for treatment at Phoenix Australia. This represents current best practice. People on the waitlist for clinical services have access to a variety of supports, including general information sheets, access to support forums (e.g., groups, online chat rooms), and referral to other support services (e.g., occupational therapy, financial aid services). We will record what this group is offered, to inform later trials. Participants in the control arm of the trial will gain access to the MemFlex program after receiving therapy at Phoenix Australia.
Control group
Active

Outcomes
Primary outcome [1] 338015 0
Post-traumatic stress disorder
Timepoint [1] 338015 0
Baseline and 5-weeks following (post 4-week intervention)
Primary outcome [2] 338033 0
Autobiographical Memory
Timepoint [2] 338033 0
Baseline and 5-weeks following (post 4-week intervention)
Primary outcome [3] 338034 0
Post-traumatic cognitions
Timepoint [3] 338034 0
Baseline and 5-weeks following (post 4-week intervention)
Secondary outcome [1] 434125 0
Depression
Timepoint [1] 434125 0
Baseline and 5-weeks following (post 4-week intervention)
Secondary outcome [2] 434126 0
Anxiety
Timepoint [2] 434126 0
Baseline and 5-weeks following (post 4-week intervention)
Secondary outcome [3] 434129 0
Trauma memory quality
Timepoint [3] 434129 0
Baseline and 5-weeks following (post 4-week intervention)
Secondary outcome [4] 434130 0
Acceptability
Timepoint [4] 434130 0
Baseline and 5-weeks following (post 4-week intervention)
Secondary outcome [5] 434567 0
Feasibility
Timepoint [5] 434567 0
Baseline and 5-weeks following (post 4-week intervention)

Eligibility
Key inclusion criteria
Deemed eligible for trauma-focussed treatment services at Phoenix Australia, proficient in reading and writing in English, and have access to a computer.
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 an independent researcher not affiliated with the project, who is blind to study objectives.
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 waitlist-as-usual.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
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, waitlist-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 Phoenix Australia clients opting into the study, and percentage of participants completing the study, will also be analysed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/05/2024
Actual
15/05/2024
Date of last participant enrolment
Anticipated
16/04/2025
Actual
Date of last data collection
Anticipated
21/05/2025
Actual
Sample size
Target
40
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316324 0
University
Name [1] 316324 0
The University of Melbourne
Country [1] 316324 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318510 0
None
Name [1] 318510 0
Address [1] 318510 0
Country [1] 318510 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315137 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 315137 0
Ethics committee country [1] 315137 0
Australia
Date submitted for ethics approval [1] 315137 0
27/10/2023
Approval date [1] 315137 0
09/02/2024
Ethics approval number [1] 315137 0

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

Contacts
Principal investigator
Name 133786 0
Dr Dr Caitlin Hitchock
Address 133786 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 133786 0
Australia
Phone 133786 0
+61 412950963
Fax 133786 0
Email 133786 0
[email protected]
Contact person for public queries
Name 133787 0
Dr Caitlin Hitchcock
Address 133787 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 133787 0
Australia
Phone 133787 0
+61 412950963
Fax 133787 0
Email 133787 0
[email protected]
Contact person for scientific queries
Name 133788 0
Dr Caitlin Hitchock
Address 133788 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 133788 0
Australia
Phone 133788 0
+61 412950963
Fax 133788 0
Email 133788 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?
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 ([email protected]) can be contacted regarding the IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22217Study protocol    387682-(Uploaded-19-04-2024-10-18-09)-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.