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临床试验/NCT02190968
NCT02190968已完成不适用

Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance.

University of Toronto2 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2015年3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
460
试验地点
2
主要终点
Patient Health Questionnaire-9

研究概览

简要总结

Many patients report residual depressive symptoms despite seemingly successful treatment. With the investigators' previous funding, we developed - Mindful Mood Balance - an online treatment that targets RDS by teaching specific emotion regulation and depression self-management skills that are entirely compatible with antidepressant treatment. The investigators now propose a controlled study to determine whether MMB is more effective than usual care at reducing RDS and other key outcomes. If successful, MMB's online delivery format would provide high fidelity and low-cost empirically supported management of residual symptoms, leading to more robust remission, improved functioning and sustained recovery from MDD over time.

详细描述

Residual depressive symptoms (RDS) following remission of major depressive disorder (MDD) are reported by 80-90% of adults receiving first-line antidepressant pharmacotherapy and carry an elevated risk for a chronic course of illness, rapid relapse and functional impairment. Strategies for managing residual symptoms, however, have met with mixed success. Mindful Mood Balance (MMB; R34 MH0877223) is an individually tailored, web-based treatment designed to train remitted depressed patients to disengage from dysphoria-activated depressogenic thinking that perpetuates RDS and increases risk for relapse/recurrence. MMB was developed to increase access to Mindfulness-Based Cognitive Therapy (MBCT; R01 MH066992), an empirically supported prophylactic group treatment that can be easily sequenced with acute phase antidepressant pharmacotherapy. Results from our open trial of MMB (N=100) showed an effect size of d=1.09 for pre to post treatment reductions in depression scores among patients with RDS and d=1.54 in a quasi-experimental comparison to patients receiving usual care, with an on average reduction of 1.98 points on the PHQ-9 for MMB patients. The investigators now propose a pragmatic randomized clinical trial of MMB to evaluate its effectiveness in reducing RDS in recurrently depressed patients. Patients will be members of Kaiser-Permanente Colorado (N = 460), aged 18 to 75, who score >5 and <9 on the PHQ-9, in remission from MDD and will be randomized 1:1 to either the usual depression care pathway (DepCare) or Mindful Mood Balance (MMB)+DepCare.

The investigators plan to test whether patients receiving MMB+DepCare will show greater reductions in RDS at both 8 week and 12 months follow up, than those receiving DepCare alone. The investigators are also interested in examining whether fewer patients in MMB+DepCare will relapse over the follow up and will have higher end state functioning and quality of life. In order to examine the costs associated with adding this online treatment to the Depression Care Pathways at KPCO, the investigators will calculate the marginal costs per additional number of depression free days (DFDs) for patients. Resolution of RDS can reduce the enormous personal and social costs experienced by Americans with this persistent symptom burden.

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
Double (Investigator, 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

  • Patients with a PHQ-9 score between 5 and 9
  • At least one prior episode of MDD

排除标准

  • presence of schizophrenia or current psychosis, organic mental disorder or pervasive developmental delay

研究组 & 干预措施

Mindful Mood Balance

Experimental

An 8 session internet intervention targeting residual depressive symptoms.

干预措施: Usual Depression Care (Behavioral)

Mindful Mood Balance

Experimental

An 8 session internet intervention targeting residual depressive symptoms.

干预措施: Mindful Mood Balance (Behavioral)

Usual Depression Care

Active Comparator

Usual Depression Care through Kaiser Permanente Colorado

干预措施: Usual Depression Care (Behavioral)

结局指标

主要结局

Patient Health Questionnaire-9

时间窗: Between baseline to 12 weeks.

Conversion from moderate/high risk to low risk symptom categories, defined as a patient whose PHQ-9 score drops from a baseline PHQ-9 score between 5 and 9 to a mean score of 4 or less

次要结局

  • Ruminative Responses Scale(Change from Baseline to 6 weeks, 12 weeks and 15 months)
  • Five Facet Mindfulness Scale(Change from Baseline to 6 weeks, 12 weeks and 15 months)
  • Experiences Questionnaire(Change from Baseline to 6 weeks, 12 weeks and 15 months)
  • Five Facet Mindfulness Questionnaire(Change from Baseline to 6 weeks, 12 weeks and 15 months)

研究者

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

Zindel Segal

Professor

University of Toronto

研究点 (2)

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