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临床试验/NCT02614326
NCT02614326已完成2 期

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

Medical Research Council Cognition and Brain Sciences Unit3 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
70
试验地点
3
主要终点
Number of depression free days at 12 month follow-up

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Number of depression free days at 12 month follow-up

时间窗: 12 months post-intervention

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

Time to depressive relapse

时间窗: 12 months post-intervention

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

次要结局

  • Depressive status at 12 month follow-up(12 months post-intervention)
  • Depression symptoms at 12 month follow-up(12 months post-intervention)
  • Autobiographical memory retrieval(Measured within one week of completing the intervention)

研究者

发起方
Medical Research Council Cognition and Brain Sciences Unit
申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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