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Major Depressive DisorderPhase 2NCT02614326

MemFlex to Prevent Depressive Relapse

A Phase 2 study testing Autobiographical Memory Flexibility (MemFlex) training and Psychoeducation in people with Major Depressive Disorder, run by Medical Research Council Cognition and Brain Sciences Unit at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A wealth of research has demonstrated that they way in which the investigators recall our personal, autobiographical memories is influential in the course of depression. Biases in the recall of autobiographical memory occur in the midst of a depressive episode, and are shown to prolong symptoms, however these biases… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Autobiographical Memory Flexibility (MemFlex) training and Psychoeducation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesUnited Kingdom
Study dates
Jan 2016to Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets criteria for Major Depressive Disorder but is currently in remission, indexed on the Structured Clinical Interview for the DSM (SCID; First et al., 1996)
  • 18 years of age or older

Who cannot join

  • Meets criteria for a current Major Depressive Episode, indexed on the SCID
  • Meets criteria for another mood disorder (e.g., Bipolar disorder), indexed on the SCID
  • Current alcohol or substance dependence, or currently experiencing psychotic symptoms, indexed on the SCID
  • Experience of intellectual disability, traumatic brain injury, or other neurological condition which may impact memory recall, assessed via self-report

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • MRC Cognition and Brain Sciences Unit

    Cambridge, CB2 7EF

  • Cambridge and Peterborough NHS Foundation Trust

    Cambridge

Other trials in United Kingdom

About this study

Official title: A Randomised Controlled Trial of the Efficacy of Autobiographical Memory Flexibility (MemFlex) Training in Preventing Relapse of Recurrent Depression

A wealth of research has demonstrated that they way in which the investigators recall our personal, autobiographical memories is influential in the course of depression. Biases in the recall of autobiographical memory occur in the midst of a depressive episode, and are shown to prolong symptoms, however these biases also remain when depression remits, and may predispose the individual towards relapse. A novel cognitive intervention, MemFlex, aims to train individuals to be flexible in their retrieval of autobiographical memories, and thereby reduce depressive relapse. Changes in memory bias may also have an effect on intermediate processes that increase risk of depression, such as rumination, impaired problem solving, and cognitive avoidance. This feasibility trial compares the effects of MemFlex and Psychoeducation in their ability to reduce memory bias and intermediate cognitive risk factors, and thereby depressive relapse, in individuals remitted from Major Depressive Disorder. Clinical outcome and process measures will be assessed immediately following completion of the intervention, at 6 months post-intervention, and at 12 months post-intervention. If encouraging, the results of this pilot trial may provide a foundation for a later phase trial.

Being tested
Autobiographical Memory Flexibility (MemFlex) training, Psychoeducation
Keywords
Depression, Cognitive risk factors, Autobiographical memory, Cognitive bias, Relapse prevention
Medical subject headings
Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autobiographical Memory Flexibility (MemFlex) trainingBehavioural

    Also called MemFlex

    As in experimental arm description

  • PsychoeducationBehavioural

    As in experimental arm description

Study groups in NCT02614326
Study groupRoleWhat they receive
Memory Flexibility (MemFlex) TrainingExperimentalMemFlex training draws on cognitive bias modification and memory specificity training techniques (Raes et al., 2009; Dalgleish et al., 2014). MemFlex is primarily self-guided and aims to reduce autobiographical memory biases associated with depression. The training is presented over one face-to-face session and eight self-guided sessions. In the initial session, the researcher introduces cued-recall tasks used throughout the workbook, and guides the participant in completion of the tasks. When understanding of the basic principles is satisfactory, the researcher assists the participant to set a schedule for completion of the workbook over the following four weeks. The participant will receive a phone call at the beginning of week three to check progress, and clarify any difficulties.
Receives: Behavioral: Autobiographical Memory Flexibility (MemFlex) training
PsychoeducationPlacebo comparatorThe psychoeducation condition will also complete an initial face-to-face session. This session will cover the symptoms and causes of depression, and the workbook will be introduced. The workbook will consist of eight self-guided sessions that the individual will be required to complete over four weeks. The workbook content will cover the presentation of depression and basic information on factors associated with depression, such as worry, procrastination, and sleep difficulties. Each session consists of psychological theories of the topic, followed by a series of questions about the material to ensure participant engagement. The participant will receive a phone call from a team member at the beginning of week three to check progress, and clarify any difficulties.
Receives: Behavioral: Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to depressive relapse

    Length of time from post-intervention assessment to occurrence of any major depressive episode within the 12 month follow-up period

    Measured: 12 months post-intervention

  2. Number of depression free days at 12 month follow-up

    Number of depression free days as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)

    Measured: 12 months post-intervention

Secondary outcomes (3)

  1. Depressive status at 12 month follow-up

    Presence of a Major Depressive Episode as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)

    Measured: 12 months post-intervention

  2. Depression symptoms at 12 month follow-up

    Score on the Beck Depression Inventory

    Measured: 12 months post-intervention

  3. Autobiographical memory retrieval

    Scores for specific and alternating blocks of the alternating instructions autobiographical memory task (Dritschel et al., 2013)

    Measured: Measured within one week of completing the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionAug 2020
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02614326
Sponsor's protocol ID
MemFlex to prevent relapse
Status last verified
May 2021
First submitted
19 Nov 2015
Last updated
26 May 2021
Results posted
No
Data monitoring committee
No

Publications

  • Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory II. San Antonio, TX: Psychological Corporation.

  • Beck, A. T., & Steer, R. A. (1993). Beck Anxiety Inventory Manual. San Antonio, TX: Psychological Corporation.

  • Dritschel B, Beltsos S, McClintock SM. An "alternating instructions" version of the Autobiographical Memory Test for assessing autobiographical memory specificity in non-clinical populations. Memory. 2014;22(8):881-9. doi: 10.1080/09658211.2013.839710. Epub 2013 Nov 12.

    PubMed 24215524

  • First, M. B., Spitzer, R. L., Gibbon, M., & Williams, J. B. (2002). Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition. New York: Biometrics Research, New York State Psychiatric Institute.

  • Treynor, W., Gonzalez, R., & Nolen-Hoeksema, S. (2003). Rumination reconsidered: A psychometric analysis. Cognitive Therapy and Research, 27, 247-259. doi: 10.1023/A:1023910315561

  • Marx EM, Williams JM, Claridge GC. Depression and social problem solving. J Abnorm Psychol. 1992 Feb;101(1):78-86. doi: 10.1037//0021-843x.101.1.78.

    PubMed 1537977

  • Sexton KA, Dugas MJ. The Cognitive Avoidance Questionnaire: validation of the English translation. J Anxiety Disord. 2008;22(3):355-70. doi: 10.1016/j.janxdis.2007.04.005. Epub 2007 Apr 25.

    PubMed 17544253

  • Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.

    PubMed 4436473

  • Keller MB, Lavori PW, Friedman B, Nielsen E, Endicott J, McDonald-Scott P, Andreasen NC. The Longitudinal Interval Follow-up Evaluation. A comprehensive method for assessing outcome in prospective longitudinal studies. Arch Gen Psychiatry. 1987 Jun;44(6):540-8. doi: 10.1001/archpsyc.1987.01800180050009.

    PubMed 3579500

  • Hitchcock C, Gormley S, O'Leary C, Rodrigues E, Wright I, Griffiths K, Gillard J, Watson P, Hammond E, Werner-Seidler A, Dalgleish T. Study protocol for a randomised, controlled platform trial estimating the effect of autobiographical Memory Flexibility training (MemFlex) on relapse of recurrent major depressive disorder. BMJ Open. 2018 Jan 29;8(1):e018194. doi: 10.1136/bmjopen-2017-018194.

    PubMed 29382674

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autobiographical Memory Flexibility (MemFlex) training and Psychoeducation in people with Major Depressive Disorder, run by Medical Research Council Cognition and Brain Sciences Unit at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to depressive relapse (time frame: 12 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02614326, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.

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