Neural, Molecular and Psychological Mechanisms and Predictors of Treatment Response to Mindfulness-based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in neural connectivity
研究概览
简要总结
The primary purpose of this study is to investigate neural mechanisms and predictors of treatment outcome in Mindfulness-Based Cognitive Therapy (MBCT) for recurrent Major Depressive Disorder.
详细描述
AIM AND HYPOTHESES
The primary aim is to investigate treatment mechanisms of MBCT and markers of relapse risk.
Controlled design:
First, we aim to first investigate the effect of treatment on clinical outcomes in the controlled design post treatment and at 3 months follow up. Second, we will run mediation analyses of hypothesized mechanisms (increased mindfulness skills, decentering, interoceptive and decreased rumination, and change in neural connectivity in a priori networks), and finally check for moderating influences of vulnerability markers (childhood trauma, no. episodes of depression and residual symptoms).
Prospective design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants are masked at baseline assessment to treatment allocation. Outcome assessors are masked to treatment allocation.
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
- •Age above 18 years
- •Meeting DSM-IV criteria for a history of recurrent Major Depressive Disorder (MDD) with or without a current episode of depression
- •Recurrent MDD evaluated a being the primary disorder.
- •Danish literacy
排除标准
- •A history of schizophrenia, schizoaffective disorder, bipolar disorder, current severe substance abuse, organic mental disorder, current/past psychosis, pervasive developmental delay, persistent antisocial behaviour, persistent self-injury requiring clinical management/therapy
- •Formal concurrent psychotherapy
- •Previous Mindfulness-Based Cognitive Therapy/Mindfulness-Based Stress Reduction
- •Anti-psychotic medication and benzodiazepines
- •Standard exclusion criteria for undergoing magnetic resonance imaging (MRI) procedures for research purposes, i.e., claustrophobia, pregnancy, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, non-MR-compatible implants or devices.
研究组 & 干预措施
TAU
Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy.
干预措施: TAU (Other)
MBCT + TAU
Mindfulness-based Cognitive Therapy (MBCT) a 8 week group based intervention delivered according to the protocol by Segal, Williams and Teasdale (2013) plus treatment as usual (TAU) . TAU is restricted to antidepressant medication and no psychological therapy.
干预措施: TAU (Other)
MBCT + TAU
Mindfulness-based Cognitive Therapy (MBCT) a 8 week group based intervention delivered according to the protocol by Segal, Williams and Teasdale (2013) plus treatment as usual (TAU) . TAU is restricted to antidepressant medication and no psychological therapy.
干预措施: MBCT (Behavioral)
结局指标
主要结局
Change in neural connectivity
时间窗: Baseline and 8 weeks
Neural connectivity will be measured with functional magnetic resonance (fMRI). Selected a priory networks for seed-based analyses: Default mode Network and Salience Network
次要结局
- Change in perceived stress(Baseline and 8 weeks)
- Change in decentering(Baseline and 8 weeks)
- Time to relapse or recurrence of depression(12 months follow up)
- Mitochondrial DNA Copy Number(Baseline and 8 weeks)
- Change in interleukin gene expression(Baseline and 8 weeks)
- Change in emotional processing bias(Baseline and 8 weeks)
- cRP expression(Baseline and 8 weeks)
- Change in INFG gene expression(Baseline and 8 weeks)
- Change in depressive symptoms(Baseline and 8 weeks)
- Change in gene expression of glutamate receptor(Baseline and 8 weeks)
- Change in mindfulness skills(Baseline and 8 weeks)
- Change in rumination(Baseline and 8 weeks)
- Change in protein expression of tumor necrosis factor(Baseline and 8 weeks)
- Change in NF-kB gene expression(Baseline and 8 weeks)
- Change in interoceptive awareness(Baseline and 8 weeks)
- Change in interleukin protein expression(Baseline and 8 weeks)
- Change in gene expression of norepinephrine transporter(Baseline and 8 weeks)
- Change in gene expression of TNF(Baseline and 8 weeks)
- Change in NF-kB protein expression(Baseline and 8 weeks)
- Change in Interferon gamma protein expression(Baseline and 8 weeks)
研究者
Anne Maj van der Velden
PhD fellow
University of Aarhus