MemFlex to Prevent Depressive Relapse

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614326
• Other study ID #: MemFlex to prevent relapse
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: May 2021
• Source: Medical Research Council Cognition and Brain Sciences Unit
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Recurrence

Intervention

Behavioral:
• Autobiographical Memory Flexibility (MemFlex) training
As in experimental arm description
• Psychoeducation
As in experimental arm description

Locations

Country	Name	City	State
United Kingdom	Cambridge and Peterborough NHS Foundation Trust	Cambridge
United Kingdom	MRC Cognition and Brain Sciences Unit	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council Cognition and Brain Sciences Unit

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

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. — View Citation

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

Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory II. 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. Erratum in: Memory. 2014;22(5):i. Beltosis, Stamatis[corrected to Beltsos, Stamatis]. — View Citation

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.

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. — View Citation

Marx EM, Williams JM, Claridge GC. Depression and social problem solving. J Abnorm Psychol. 1992 Feb;101(1):78-86. — View Citation

Sexton KA, Dugas MJ. The Cognitive Avoidance Questionnaire: validation of the English translation. J Anxiety Disord. 2008;22(3):355-70. Epub 2007 Apr 25. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rumination	Total and sub-scale scores on the Rumination Response Scale (Treynor, Gonzalez, Nolen-Hoeksema, 2003)	Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Other	Problem solving	The total number of means and total effectiveness scores on the abbreviated version of the Means-Ends Problem Solving task (Marx, Williams, & Claridge, 1992)	Measured within one week of completing the intervention, and six months post-intervention
Other	Cognitive avoidance	Total score on the Cognitive Avoidance Questionnaire (Sexton & Dugas, 2008)	Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Other	Anxiety symptoms	Total score on the Beck Anxiety Inventory (Beck & Steer, 1993)	Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Other	Hopelessness	Total score on the Beck Hopelessness Scale (Beck, Weissman, Lester, & Trexler, 1974)	Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Primary	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	12 months post-intervention
Primary	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)	12 months post-intervention
Secondary	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)	12 months post-intervention
Secondary	Depression symptoms at 12 month follow-up	Score on the Beck Depression Inventory	12 months post-intervention
Secondary	Autobiographical memory retrieval	Scores for specific and alternating blocks of the alternating instructions autobiographical memory task (Dritschel et al., 2013)	Measured within one week of completing the intervention