Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance
Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Colorado
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Denver、Colorado、美国、80237-8066
- Kaiser Permanente Institute for Health Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with a PHQ-9 score between 5 and 9
- At least one prior episode of MDD
Exclusion Criteria:
- presence of schizophrenia or current psychosis, organic mental disorder or pervasive developmental delay
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Mindful Mood Balance
An 8 session internet intervention targeting residual depressive symptoms.
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Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.
Mindful Mood Balance is an individually tailored, web-based version of Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2002) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990).
Patients participated in 8 internet sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.
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有源比较器：Usual Depression Care
Usual Depression Care through Kaiser Permanente Colorado
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Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Patient Health Questionnaire-9
大体时间：Change from Baseline to 12 weeks and 15 months
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Changes in self reported depressive symptom severity
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Change from Baseline to 12 weeks and 15 months
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Patient Health Questionnaire-9
大体时间：Between 12 weeks and 15 months
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Rates of depressive relapse, defined as patients who score 15 or greater on the PHQ-9
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Between 12 weeks and 15 months
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Patient Health Questionnaire-9
大体时间：Between baseline to 12 weeks.
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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
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Between baseline to 12 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ruminative Responses Scale
大体时间：Change from Baseline to 6 weeks, 12 weeks and 15 months
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A self-report measure of rumination
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Change from Baseline to 6 weeks, 12 weeks and 15 months
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Five Facet Mindfulness Questionnaire
大体时间：Change from Baseline to 6 weeks, 12 weeks and 15 months
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Self report measure of mindful awareness
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Change from Baseline to 6 weeks, 12 weeks and 15 months
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Five Facet Mindfulness Scale
大体时间：Change from Baseline to 6 weeks, 12 weeks and 15 months
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Self report measure of mindful awareness
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Change from Baseline to 6 weeks, 12 weeks and 15 months
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Experiences Questionnaire
大体时间：Change from Baseline to 6 weeks, 12 weeks and 15 months
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Self report measure of decentering/wider awareness
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Change from Baseline to 6 weeks, 12 weeks and 15 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Depression Free Days
大体时间：Change from Baseline to 12 weeks and 15 months
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Self report of days free of depression
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Change from Baseline to 12 weeks and 15 months
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Generalized Anxiety Disorder Assessment - 7
大体时间：Change from Baseline to 12 weeks and 15 months
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Self report measure of generalized anxiety
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Change from Baseline to 12 weeks and 15 months
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Short Form Health Survey - 12
大体时间：Change from Baseline to 12 weeks and 15 months
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Self report measure of physical and mental health
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Change from Baseline to 12 weeks and 15 months
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Emotion Dot Probe Task
大体时间：Change from Baseline to 12 weeks and 15 months
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A behavioural measure of attentional bias
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Change from Baseline to 12 weeks and 15 months
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合作者和调查者
调查人员
- 首席研究员：Zindel V Segal, PhD、University of Toronto
出版物和有用的链接
一般刊物
- Boggs JM, Beck A, Felder JN, Dimidjian S, Metcalf CA, Segal ZV. Web-based intervention in mindfulness meditation for reducing residual depressive symptoms and relapse prophylaxis: a qualitative study. J Med Internet Res. 2014 Mar 24;16(3):e87. doi: 10.2196/jmir.3129.
- Segal ZV, Bieling P, Young T, MacQueen G, Cooke R, Martin L, Bloch R, Levitan RD. Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Arch Gen Psychiatry. 2010 Dec;67(12):1256-64. doi: 10.1001/archgenpsychiatry.2010.168.
- Dimidjian S, Beck A, Felder JN, Boggs JM, Gallop R, Segal ZV. Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls. Behav Res Ther. 2014 Dec;63:83-9. doi: 10.1016/j.brat.2014.09.004. Epub 2014 Sep 18.
- Boggs JM, Ritzwoller DP, Beck A, Dimidjian S, Segal ZV. Cost-Effectiveness of a Web-Based Program for Residual Depressive Symptoms: Mindful Mood Balance. Psychiatr Serv. 2022 Feb 1;73(2):158-164. doi: 10.1176/appi.ps.202000419. Epub 2021 Jul 29.
- Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693. Erratum In: JAMA Psychiatry. 2020 May 1;77(5):545.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- R01MH102229-01A1 (美国 NIH 拨款/合同)
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