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MemFlex to Prevent Depressive Relapse

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Autobiographical Memory Flexibility (MemFlex) training
Psychoeducation
Sponsored by
Medical Research Council Cognition and Brain Sciences Unit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Major Depressive Disorder focused on measuring Depression, Cognitive risk factors, Autobiographical memory, Cognitive bias, Relapse prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MRC Cognition and Brain Sciences Unit
  • Cambridge and Peterborough NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Memory Flexibility (MemFlex) Training

Psychoeducation

Arm Description

MemFlex 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.

The 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.

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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)
Depression symptoms at 12 month follow-up
Score on the Beck Depression Inventory
Autobiographical memory retrieval
Scores for specific and alternating blocks of the alternating instructions autobiographical memory task (Dritschel et al., 2013)

Full Information

First Posted
November 19, 2015
Last Updated
May 25, 2021
Sponsor
Medical Research Council Cognition and Brain Sciences Unit
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1. Study Identification

Unique Protocol Identification Number
NCT02614326
Brief Title
MemFlex to Prevent Depressive Relapse
Official Title
A Randomised Controlled Trial of the Efficacy of Autobiographical Memory Flexibility (MemFlex) Training in Preventing Relapse of Recurrent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Research Council Cognition and Brain Sciences Unit

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Cognitive risk factors, Autobiographical memory, Cognitive bias, Relapse prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Memory Flexibility (MemFlex) Training
Arm Type
Experimental
Arm Description
MemFlex 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.
Arm Title
Psychoeducation
Arm Type
Placebo Comparator
Arm Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Autobiographical Memory Flexibility (MemFlex) training
Other Intervention Name(s)
MemFlex
Intervention Description
As in experimental arm description
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
As in experimental arm description
Primary Outcome Measure Information:
Title
Time to depressive relapse
Description
Length of time from post-intervention assessment to occurrence of any major depressive episode within the 12 month follow-up period
Time Frame
12 months post-intervention
Title
Number of depression free days at 12 month follow-up
Description
Number of depression free days as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)
Time Frame
12 months post-intervention
Secondary Outcome Measure Information:
Title
Depressive status at 12 month follow-up
Description
Presence of a Major Depressive Episode as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)
Time Frame
12 months post-intervention
Title
Depression symptoms at 12 month follow-up
Description
Score on the Beck Depression Inventory
Time Frame
12 months post-intervention
Title
Autobiographical memory retrieval
Description
Scores for specific and alternating blocks of the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Time Frame
Measured within one week of completing the intervention
Other Pre-specified Outcome Measures:
Title
Rumination
Description
Total and sub-scale scores on the Rumination Response Scale (Treynor, Gonzalez, Nolen-Hoeksema, 2003)
Time Frame
Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Title
Problem solving
Description
The total number of means and total effectiveness scores on the abbreviated version of the Means-Ends Problem Solving task (Marx, Williams, & Claridge, 1992)
Time Frame
Measured within one week of completing the intervention, and six months post-intervention
Title
Cognitive avoidance
Description
Total score on the Cognitive Avoidance Questionnaire (Sexton & Dugas, 2008)
Time Frame
Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Title
Anxiety symptoms
Description
Total score on the Beck Anxiety Inventory (Beck & Steer, 1993)
Time Frame
Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Title
Hopelessness
Description
Total score on the Beck Hopelessness Scale (Beck, Weissman, Lester, & Trexler, 1974)
Time Frame
Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Dalgleish
Organizational Affiliation
Medical Research Council Cognition and Brain Sciences Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
MRC Cognition and Brain Sciences Unit
City
Cambridge
ZIP/Postal Code
CB2 7EF
Country
United Kingdom
Facility Name
Cambridge and Peterborough NHS Foundation Trust
City
Cambridge
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory II. San Antonio, TX: Psychological Corporation.
Results Reference
background
Citation
Beck, A. T., & Steer, R. A. (1993). Beck Anxiety Inventory Manual. San Antonio, TX: Psychological Corporation.
Results Reference
background
PubMed Identifier
24215524
Citation
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].
Results Reference
background
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
1537977
Citation
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.
Results Reference
background
PubMed Identifier
17544253
Citation
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.
Results Reference
background
PubMed Identifier
4436473
Citation
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.
Results Reference
background
PubMed Identifier
3579500
Citation
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.
Results Reference
background
PubMed Identifier
29382674
Citation
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.
Results Reference
derived

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MemFlex to Prevent Depressive Relapse

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