Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000669493
Ethics application status
Approved
Date submitted
28/05/2025
Date registered
25/06/2025
Date last updated
25/06/2025
Date data sharing statement initially provided
25/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Can people with memory concerns and a history of electroconvulsive therapy benefit from computerised memory strategy practice?
Scientific title
Can people with memory concerns and a history of electroconvulsive therapy benefit from computerised memory strategy practice?
Secondary ID [1] 314547 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Memory problems after electroconvulsive therapy (ECT) 337648 0
Mental Health Disorders 337649 0
Condition category
Condition code
Mental Health 333974 333974 0 0
Psychosis and personality disorders
Mental Health 333975 333975 0 0
Depression
Mental Health 333978 333978 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention includes a two-week period of self-guided access to computerised memory strategy training exercises, accessed on the MEMOResearch online platform.

Participants in the intervention will be provided with access to an online platform (MEMOResearch) for a period of two weeks.

MEMOResearch can be accessed from a computer or tablet at the time, place, and frequency of the participants choosing within the two-week intervention period. Participants may access three online exercises for training and practice in use of three memory strategies, including:
1. Making associations to remember a person's name.
2. Focusing attention and using self-talk to remember a route.
3. Note taking for remembering auditory information.

The online exercises automatically adapt in difficulty to this individual's level of achievement on each exercise. A level-1 exercise may be completed in 1 minute, while a level-5 exercise may be completed in 5 minutes.

The online platform includes functions to report on how often participants engage in exercises and what level they achieve.
Intervention code [1] 331174 0
Treatment: Other
Comparator / control treatment
Participants in the control group will be given a 4-page hand-out of memory strategies to practice in a self-guided manner over the two-week intervention period. Strategies include both internal strategies (e.g., making and association, visualising information) and external strategies (e.g., writing things down, using calendars).
Control group
Active

Outcomes
Primary outcome [1] 341634 0
Memory Performance
Timepoint [1] 341634 0
Baseline and post-intervention (two-week post-intervention assessment period)
Primary outcome [2] 341635 0
Subjective Memory Measure
Timepoint [2] 341635 0
Baseline and post-intervention (two-week post-intervention assessment period)
Primary outcome [3] 341636 0
Satisfaction
Timepoint [3] 341636 0
Post-intervention (two-week post-intervention assessment period)
Secondary outcome [1] 448144 0
Mood
Timepoint [1] 448144 0
Baseline and post-intervention (two-week post-intervention assessment period)
Secondary outcome [2] 448145 0
Subjective Memory
Timepoint [2] 448145 0
Baseline and post-intervention (two-week post-intervention assessment period)

Eligibility
Key inclusion criteria
• Current Sydney Local Health District (SLHD) mental health treatment consumers
• Have had ECT within the previous two years (min. 2 weeks since the course of ECT was completed)
• Acknowledge concern regarding memory
• Between the ages of 18 and 70 (inclusive)
• Have access to a computer, laptop, iPad, or Tablet
• Willing to provide informed consent and to participate and comply with the study requirements
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participants with a diagnosis of major neurocognitive disorder
• Participants unable to independently engage in the intervention or assessment, for example, due to being unable to read instructions or engage in exercises in English
• Participants who have received ECT within the previous two weeks, or who are likely to require further ECT during the study period, will be excluded from the study .

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 will occur after eligibility confirmed and participant enrolled in trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
14/01/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319095 0
Government body
Name [1] 319095 0
Sydney Local Health District Allied Health Small Grant Scheme
Country [1] 319095 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 321561 0
None
Name [1] 321561 0
Address [1] 321561 0
Country [1] 321561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317695 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 317695 0
Ethics committee country [1] 317695 0
Australia
Date submitted for ethics approval [1] 317695 0
23/01/2025
Approval date [1] 317695 0
07/04/2025
Ethics approval number [1] 317695 0
2025/ETH00156

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

Contacts
Principal investigator
Name 141838 0
Dr Talia Nardo
Address 141838 0
Marrickville Community Mental Health, 155 Livingstone Road, Marrickville, NSW 2204
Country 141838 0
Australia
Phone 141838 0
+61 2 95620523
Fax 141838 0
Email 141838 0
[email protected]
Contact person for public queries
Name 141839 0
Talia Nardo
Address 141839 0
Marrickville Community Mental Health, 155 Livingstone Road, Marrickville, NSW 2204
Country 141839 0
Australia
Phone 141839 0
+61 2 95620523
Fax 141839 0
Email 141839 0
[email protected]
Contact person for scientific queries
Name 141840 0
Talia Nardo
Address 141840 0
Marrickville Community Mental Health, 155 Livingstone Road, Marrickville, NSW 2204
Country 141840 0
Australia
Phone 141840 0
+61 2 95620523
Fax 141840 0
Email 141840 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.