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临床试验/NCT01145872
NCT01145872已完成3 期

The Effects and Mechanisms of MBCT on Depressive Symptoms and Depression Relapse

University of Denver1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
92
试验地点
1
主要终点
Depression Relapse

研究概览

简要总结

This research proposal is intended to elucidate the efficacy and mechanisms underlying Mindfulness Based Cognitive Therapy (MBCT) in a population in remission from recurrent Major Depressive Disorder (MDD). The first objective of the study is to replicate previous studies' findings of MBCT's effects on decreasing depressive symptoms and depression relapse rates. However, this proposal aims to make a novel contribution to the literature by using a randomized, controlled design, and comparing the effects of MBCT to an active control condition (ACC). The use of a well-designed ACC will enable us to control for confounding variables such as social support and expected outcomes, thus allowing us to determine whether elements specific to MBCT lead to its salutary effects (Aim 1). Previous MBCT studies have largely relied on self-report measurement methodologies, limiting valid conclusions about the nature of MBCT. Further, few studies have examined the mechanisms underlying effects of MBCT on depressive symptoms and relapse. Theoretical considerations and preliminary empirical evidence suggest emotional, physiological, and cognitive functioning to be promising mechanisms of MBCT. Therefore, the investigators propose to assess each of these potential mechanisms of MBCT using self-report, autonomic physiological, and reaction time tasks (Aim 2). Collectively, these aims are expected to strengthen the evidence base for MBCT while cultivating a scientific model for its effects and mechanisms on decreasing depressive symptoms and depression relapse rates.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •must comprehend English well
  • •be 18-55 years of age
  • •meet enhanced DSM-IV criteria for remission of MDD, recurrent and have a history of three or more previous episodes of DSM-IV major depression in the absence of a history of mania or hypomania
  • •at least one of those episodes was within the past two years
  • •participant must be in remission and if on antidepressant medication (ADM), they must be on a stable dose with no change in type or amount for past 12 weeks or participants must be off ADM at T1 for at least the preceding 12 weeks
  • •have, at screening assessment, residual depressive symptoms indicated by a Beck Depression Inventory-II (BDI-II;[72]) score between 6-19.

排除标准

  • •bipolar disorder
  • •schizophrenia or borderline personality disorder
  • •current suicidal thoughts and/or suicide attempt in last two months
  • •current anxiety disorder if it constitutes the predominant aspect of the clinical presentation and requires primary treatment not offered in the project
  • •substance abuse or dependence within last three months
  • •dementia or subnormal intellectual potential
  • •current obsessive-compulsive disorder
  • •current eating disorder
  • •history of previous mindfulness training or more than eight lifetime sessions of CBT
  • •current use of psychotherapy or counseling

研究组 & 干预措施

Mindfulness Based Cognitive Therapy

Experimental

干预措施: Mindfulness Based Cognitive Therapy (Behavioral)

Health Enhancement Program

Active Comparator

干预措施: Health Enhancement Program (Behavioral)

结局指标

主要结局

Depression Relapse

时间窗: 1 year

次要结局

  • Depressive Symptoms(1 Year)

研究者

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

Amanda Shallcross

Post-Doctoral Researcher

University of Denver

研究点 (1)

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