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临床试验/NCT00871299
NCT00871299已完成不适用

Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2009年9月1日最近更新:
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
173
试验地点
1
主要终点
Hamilton Depression Rating Scale (HAMD-17)

研究概览

简要总结

This study is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus Health-Enhancement Program (HEP) for patients with treatment-resistant major depressive disorder (MDD). Both arms of the study will continue to receive the standard medication management treatment as usual (TAU) throughout the study. MBCT is a new technique that has been found to be effective for prevention of relapse in individuals in complete recovery from depression. MBCT is a group-based, 8-week intervention that uses mindfulness meditation as its core therapeutic ingredient. It teaches people to have a different relationship to depressive thoughts and feelings. This study will use an active condition called the Health Enhancement Program (HEP) which was specifically developed to serve as a comparison condition for mindfulness interventions. HEP has been shown to decrease global stress levels and to increase perceived health. Stress has been considered a contributor to depression. One hundred and seventy four patients with MDD who have failed two or more adequate antidepressant trials will be identified and randomly assigned to one of two groups: MBCT+TAU or HEP+TAU. All patients who enroll in the study will undergo follow-up assessments at 3, 6, 9 and 12 months following the intervention. A supplemental portion of the study will enroll 88 patients to undergo functional magnetic resonance imagining (fMRI) scans immediately before and after treatment to better understand the neural pathways implicated in depression and those that may be affected through treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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
否

入选标准

  • •DSM-IV TR Diagnosis of Major Depression receiving medication management.
  • •Adequate trial of 2 or more antidepressants (ATHF) for a minimum of 6 weeks (one of which at UCSF).
  • •Hamilton Depression Rating Scale 17 score ≥ 14
  • •Any Ethnicity
  • •English Speaking
  • •Male or Female
  • •No current psychotherapy (i.e. only medication management treatment) or plan to start new psychotherapy during MBCT or HEP

排除标准

  • •Bipolar Disorder, Obsessive Compulsive Disorder, Schizophrenia, Schizoaffective Disorder, Antisocial and Borderline Personality Disorders, Current Eating Disorder, Pervasive Development Delay Major Depression with Psychotic Features
  • •Active Suicidality (per HAM-D17 > 1 on item 3)
  • •Meditation Practice once or more per week; yoga more than twice per week at study entry
  • •Substance Abuse Disorder within 6 months
  • •Cognitive Disorder with Mini Mental Status Exam score < 25
  • •Medical illness rated 4 on Cumulative Illness Rating Scale

研究组 & 干预措施

1

Experimental

Mindfulness Based Cognitive Therapy (MBCT) + medication management

干预措施: Mindfulness Based Cognitive Therapy (Behavioral)

2

Active Comparator

The Health Enhancement Program (HEP) + medication management

干预措施: Health Enhancement Program and medication management (Behavioral)

结局指标

主要结局

Hamilton Depression Rating Scale (HAMD-17)

时间窗: Baseline, 4, 8, 24, 36, 52 week

次要结局

  • Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16)(Baseline, weeks 1-8, 24, 36, 52 week)
  • Short Form Health Survey-36(Baseline, 8, 24, 36, 52 week)
  • Clinical Global Improvement Scale (CGI)(Baseline, 8, 24, 36, 52 weeks)
  • Work and Social Activity Scale (WSAS)(Baseline, 8, 24,36,52 weeks)
  • Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF)(Baseline, 8, 24, 36, 52 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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