Memory reshaping for depression: a randomised controlled feasibility trial of a novel blended digital therapy
| ISRCTN | ISRCTN42876798 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42876798 |
| IRAS number | 355767 |
| Secondary identifying numbers | MR/Y008545/1 |
- Submission date
- 23/06/2025
- Registration date
- 26/06/2025
- Last edited
- 04/08/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study is testing a new kind of digital therapy for people with major depression. The therapy is designed for those who find it hard to engage with current mental health treatments, such as talking therapies or medication. It uses simple, self-guided techniques that people can use in their daily lives, especially helpful for those who are sensitive to medication or prefer to work independently. The therapy focuses on reshaping personal memories that may contribute to low mood and self-worth. It combines two approaches—one that helps people recall positive experiences more flexibly, and another that helps reduce feelings of self-blame. These methods have shown promise in earlier studies, and this trial will test how well they work together when delivered through a mobile app.
Who can participate?
Adults who have been diagnosed with major depressive disorder may be eligible to take part. There are some criteria that need to be met, and some conditions that may exclude people from participating, such as recent changes in medication.
What does the study involve?
Participants will be randomly assigned to one of two groups: one group will use the new memory reshaping app (called MemReD), and the other will use a standard online cognitive behavioural therapy (CBT) programme. Both groups will follow their assigned programme for 8 weeks. The therapy is delivered remotely, so participants can take part from home using their smartphone or tablet.
What are the possible benefits and risks of participating?
Taking part may help improve symptoms of depression, especially for those who haven’t found other treatments helpful. The study also helps researchers develop better therapies for the future. As with any mental health treatment, there may be emotional discomfort when reflecting on personal experiences, but support is available throughout the study.
Where is the study run from?
King's College London (UK)
When is the study starting and how long is it expected to run for?
February 2025 to October 2028
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Prof. Roland Zahn, roland.zahn@kcl.ac.uk
Contact information
Public, Scientific, Principal Investigator
Centre for Affective Disorders
Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London
16 De Crespigny Park
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0002-8447-1453 |
|---|---|
| Phone | +44 207848 0348 |
| roland.zahn@kcl.ac.uk |
Study information
| Study design | Feasibility randomized controlled trial using two parallel groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Memory Reshaping for Depression: a randomised controlled feasibility trial of a novel blended digital therapy |
| Study acronym | MemReD - Feasibility RCT |
| Study objectives | The primary objective of this study is to probe the feasibility of memory reshaping for depression (MemReD), a novel blended digital therapeutic which is based on two previous face-to-face interventions. This feasibility randomised controlled trial will compare the new programme against the gold standard self-guided therapy in the UK National Health Service: computerised cognitive behavioural therapy (online CBT). Our secondary objective is to estimate standard deviations of the outcome measures allowing us to inform sample size requirements for future efficacy and safety trials. |
| Ethics approval(s) |
Approved 03/07/2025, London - South East Research Ethics Committee (Health Research Authority, 2 Redman Place, London, E20 1JQ, United Kingdom; +44 207 104 8000; londonsoutheast.rec@hra.nhs.uk), ref: 25/LO/0445 |
| Health condition(s) or problem(s) studied | Treatment of major depressive disorder |
| Intervention | This is a single-blind (assessors blinded for observer-rated outcomes), controlled feasibility randomisation trial. Our Clinical Trials Unit will use minimisation for baseline Maudsley Staging Model treatment-resistance subscale scores for i) duration (acute (01), sub-acute (02), chronic (03)), ii) symptom severity (mild (01), moderate (02), severe without psychosis (03)), and iii) treatment failures (mild (01), moderate (02), severe (03)) (Fekadu et al., 2009) when randomising into 1) 8 weeks of standard online computerised CBT which we will give participants access to vs. 2) our blended digital therapy , the MemReD programme (5 weeks of Memory Flexibility Training, followed by 3 weeks of self-blame-related memory re-appraisal training). MemReD arm: The novel psychological intervention consists of four live video-based sessions with our research assistant (one memory flexibility and three self-blame reappraisal sessions based on the protocols from our previously published pilot trials with an additional strategy added during our lived experience co-design stage (“Standing up for yourself”, see also above) and use of the MemReD app to work through the 10 steps of the self-guided MemFlex programme and to remind of psychological strategies for the blame rebalancing training, log their usefulness and monitor symptoms. The MemReD app also hosts general information about depression in the form of short videos which have been co-designed with the MemReD expert by lived experience user group. Internet CBT arm: Participants will get access to the standard internet CBT programme used in NHS improved access to psychological treatment services (IAPT) which is a self-guided programme over 8 weeks which consists of video and text-based materials explaining the CBT-approach and allowing participants also to track their mood state using standard scales (PHQ-9 and GAD-7), similarly to the functionality within MemReD. There will be no sessions with a psychologist as this is not part of the standard internet CBT intervention. However, the research team will be available to participants with any queries or should they feel worse during this 8-week period for advice as in the MemReD arm. |
| Intervention type | Mixed |
| Primary outcome measure | Acceptability measured by loss-to-follow-up rates |
| Secondary outcome measures | Standardised follow-up assessments 10–11 weeks after the baseline visit will assess trial outcomes: 1. Adherence is measured using app engagement data automatically recorded in the app and a self-report questionnaire at follow-up. 2. Acceptability of the web-based app is also measured using the Technology Acceptance Model – Fast Form (TAM-FF) at follow-up. 3. Acceptability of the treatment programme is further measured using the Satisfaction with Therapy subscale (Oei & Green, 2008) at follow-up. 4. Costs are measured using a service use questionnaire developed at the IoPPN and follow-up. 5. Quality of life is measured using the EQ-5D-5L at baseline and follow-up. 6. Adverse event rates are measured using clinical monitoring and adverse event reporting forms at follow-up. 7. Recruitment rate is measured using trial screening logs monthly after baseline assessment. The following clinical measures will be used for characterising participants and their symptoms prior and after the intervention, but not as outcome measures per se. Standard deviation estimates for computing effect size estimates on symptom measures to inform sample size calculations for larger subsequent trials will be derived from measures of depressive symptoms: 8. Depressive symptoms are measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and final visit. This could be used as the primary outcome in our future definitive trial. 9. Global clinical change is measured using the Clinical Global Impression change scale rated by participant and blinded observer at final visit. 10. Anxiety symptoms are measured using the Generalised Anxiety Disorder – 7 (GAD-7) scale at baseline and final visit. 11. Depressive symptoms are also measured using the Maudsley Modified PHQ-9 (MM-PHQ-9) at baseline and follow-up. 12. Self-esteem is measured using the Rosenberg Self-Esteem Scale at baseline and follow-up. 13. Self-blame is measured using the moral emotion addendum of the AMDP Psychopathology Interview at baseline and follow-up. 14. Psychosocial functioning is measured using the DSM-5 Social and Occupational Functioning Scale at baseline and follow-up. 15. Psychiatric status is measured using the Psychiatric Status Ranking scale at baseline and final follow-up. |
| Overall study start date | 01/02/2025 |
| Completion date | 31/10/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 86 |
| Key inclusion criteria | 1. Age≥18 years 2. PHQ-9 score≥10 (i.e. “caseness” definition in NHS psychological treatment services) 3. Diagnosis of MDD on SCID-I for DSM-5 4. Able to understand written materials, this is essential for the scientific quality of the study, because this intervention is text-based in large parts, which at this stage of the research we are only able to provide in English with translations into other languages planned should our project be successful and allow us to obtain further funding |
| Key exclusion criteria | 1. Previously tried computerised CBT 2. High suicide risk (MINI suicidality screen) 3. Current self-harm with injuries within the last 6 months (self-report) 4. Medication changed in the last 6 weeks including dose changes (self-report) 5. Ongoing psychotherapy (self-report) 6. Past violence in the last 6 months (self-report) 7. Current aggression (screening or pre-screening assessments) 8. Current psychotic symptoms (screening or pre-screening assessments) 9. History of schizophreniform symptoms (screening or pre-screening assessments using validated screening questions) 10. Bipolar disorder including otherwise specified (structured interview for DSM-5 or pre-screening assessment) 11. Current mixed episode (structured interview for DSM-5) 12. No personal smartphone or tablet with internet access |
| Date of first enrolment | 15/08/2025 |
| Date of final enrolment | 30/05/2028 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE5 8AF
United Kingdom
Sponsor information
University/education
44-46 Aldwych
London
WC2B 4LL
England
United Kingdom
| Phone | +44 2078487306 |
|---|---|
| vpri@kcl.ac.uk | |
| Website | https://www.kcl.ac.uk/ |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The results will be pre-published and subsequently submitted to a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during the current study will be stored in anonymised format in a non-publicly available repository such as https://kcl.figshare.com/. |
Editorial Notes
04/08/2025: Ethics approval details added. The date of first enrolment was changed from 01/08/2025 to 15/08/2025.
30/06/2025: Internal review.
26/06/2025: Trial's existence confirmed by London - South East Research Ethics Committee.
