跳至主要内容
临床试验/NCT02226042
NCT02226042已完成不适用

Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy

University of Manchester2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
2
主要终点
Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures

研究概览

简要总结

This research will investigate the neuropsychological mechanisms underlying the eight-week Mindfulness-based Cognitive Therapy (MBCT) programme.

Participants in remission from depression will be seen pre- and post-MBCT to assess the underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess the relationship of these neuropsychological changes with relapse risk.

The research will focus primarily on changes in self-compassion, rumination, attention and structural brain changes, with secondary focus on other mechanisms of emotional processing and memory.

详细描述

There will be three groups in total.

  • The first group will take 36 participants in remission from major depression (rMDD) through the 8 week MBCT program.
  • A control group of 36 rMDD participants will not receive the intervention.
  • A group of never depressed healthy control participants will also be recruited.

Research visits for participants not undergoing MBCT will be separated by an 8 week gap.

All participants will be seen before and after the 8 weeks for completion of neuropsychological assessments and questionnaires.

rMDD participants will be followed up over the following 12 months to identify any predictors of relapse.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with remitted depression (rMDD):
  • At least two previous episodes of DSM-IV major depression in adulthood, diagnosed using the Mini International Neuropsychiatric Interview (M.I.N.I).
  • Full or partial remission for at least three months with two depressive episodes within the last five years.
  • A score of less than or equal to 12 on the Montgomery Asberg Depression Rating Scale (MADRS) mood assessment.
  • If on medication, no recent or planned major changes
  • Healthy volunteers:
  • In good psychological health screened with the M.I.N.I
  • All participants:
  • in good physical health (to reduce risk of confounding physical health problems).
  • sufficiently fluent in English to ensure valid understanding and completion of the tasks.
  • minimum I.Q level of 80 to ensure sufficient understanding of the neurocognitive tasks administered.
  • colour vision and acuity within normal/corrected to normal limits.
  • Exclusion criteria:
  • Any current mental health diagnosis (DSM-IV diagnosis including current major depression, bipolar disorder, psychosis, Obsessive Compulsive Disorder (OCD), substance abuse or dependence, eating disorders)
  • Physical health or neurological disorders that might interfere with the interpretation of the tasks, including a history of significant head injury.
  • In addition healthy volunteers will be without a history mental health disorders (DSM-IV)
  • Current or previous experience of mindfulness-based treatments or extensive cognitive behavioural treatment, or planned participation in psychological treatments during the key time for the study (between pre and post visits).
  • Planned major alteration in drug treatment for depression between pre and post visits.

排除标准

  • 未提供

研究组 & 干预措施

Mindfulness-based Cognitive Therapy

Experimental

Individuals currently in remission from depression will choose to enter the Mindfulness-based Cognitive Therapy (MBCT) arm and undergo the 8 week MBCT group programme

干预措施: Mindfulness-based Cognitive Therapy (Behavioral)

Non-MBCT arm

No Intervention

Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme

Healthy volunteers

No Intervention

Individuals who have never experienced major depression

结局指标

主要结局

Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures

时间窗: measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)

Two neuropsychological measures of self-compassion have been developed and will be administerat baseline and after MBCT/8 week gap (8 weeks post baseline). Self-report questionnaires will be administered before and after MBCT/8 week gap and at subsequent follow-up visits (3, 6, 12 months).

次要结局

  • Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures(measured at baseline and after the intervention/8 week gap (8 weeks post baseline) and at each follow-up visit (3 in total))
  • Changes in attention regulation following MBCT(measured at baseline and after the intervention/8 week gap (8 weeks post baseline))
  • Changes in brain structure following MBCT(measured at baseline and after the intervention (8 weeks post baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kate Williams

PhD Student

University of Manchester

研究点 (2)

Loading locations...

相似试验