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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memory Flexibility (MemFlex) Training | Experimental | 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. |
|
| Psychoeducation | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autobiographical Memory Flexibility (MemFlex) training | Behavioral | As in experimental arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Depression symptoms at 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Problem solving |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Dalgleish | Medical Research Council Cognition and Brain Sciences Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MRC Cognition and Brain Sciences Unit | Cambridge | CB2 7EF | United Kingdom | |||
| Cambridge and Peterborough NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory II. San Antonio, TX: Psychological Corporation. | ||
| Background | Beck, A. T., & Steer, R. A. (1993). Beck Anxiety Inventory Manual. San Antonio, TX: Psychological Corporation. | ||
| 24215524 | Background | 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. | |
| Background | 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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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Psychoeducation | Behavioral | As in experimental arm description |
|
Score on the Beck Depression Inventory
| 12 months post-intervention |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| Cambridge |
| United Kingdom |
| Background | 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 |
| 1537977 | Background | 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. |
| 17544253 | Background | 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. |
| 4436473 | Background | 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. |
| 3579500 | Background | 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. |
| 29382674 | Derived | 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. |
| D001519 |
| Behavior |