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
Verified date | May 2021 |
Source | Medical Research Council Cognition and Brain Sciences Unit |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge and Peterborough NHS Foundation Trust | Cambridge | |
United Kingdom | MRC Cognition and Brain Sciences Unit | Cambridge |
Lead Sponsor | Collaborator |
---|---|
Medical Research Council Cognition and Brain Sciences Unit |
United Kingdom,
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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.
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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 |
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