跳至主要内容
临床试验/NCT05802966
NCT05802966终止不适用

Cognition in Mindfulness: Negativity and Depression

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2019年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
135
试验地点
2
主要终点
Repetitive negative thinking (RNT)

研究概览

简要总结

Mindfulness-Based Cognitive Therapy (MBCT) is effective in reducing relapse rates and (residual) symptoms in major depressive disorder (MDD). However, the mechanisms underlying those MBCT-induced effects are far from clear. The goal of this study is to get more insight into the working mechanisms of MBCT. The main question to be answered is whether MBCT-induced reduction in depressive symptoms is mediated and/or moderated by repetitive negative thinking (RNT), or other factors hypothesized to be involved in the working mechanism of MBCT (e.g. mindfulness skills and self-compassion).

详细描述

Introduction

Depression is highly prevalent and is ranked by the world health organization (WHO) as the number one contributor to disability worldwide. The highly recurrent nature of the disorder contributes greatly to the burden of Major Depressive Disorder (MDD) and with every new depressive episode, outcome prospective worsen. Mindfulness Based Cognitive Therapy (MBCT) is an effective treatment to reduce relapse rates and (residual) symptoms that contribute to recurrence in MDD. However, the mechanisms underlying this MBCT-induced effect are far from clear.

Elucidating these mechanisms will provide insight in the existing individual differences in effectiveness of MBCT. Consequently, this insight will help to improve effectiveness of treatment and even personalize treatment regimes. One likely candidate that could play a major role in the positive effects of MBCT on depressive symptoms, is repetitive negative thinking (RNT). Depressive rumination is the most well-studied form in the context of depression and has been described as the process of thinking perseveratively about one's feelings and problems (such as symptoms of depression) and their possible causes and consequences. It is believed that during MBCT participants develop the ability to become aware of automatic maladaptive cognitive processes such as depressive rumination, and learn to decenter and disengage from them. Because of this core skill to be learned during MBCT patients may be prevented to enter a vicious cycle of ruminative thinking that could otherwise aggravate symptoms of depression or have resulted in a new depressive episode.

Objectives

Our main objectives are (i) to replicate the beneficial effects of MBCT on depressive symptoms and RNT in patients with chronic or recurrent depression (crMDD), and (ii) to investigate whether individual levels of RNT (iia) mediate and/or (iib) moderate the MBCT-induced reduction in depressive symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • diagnosis of chronic or recurrent MDD according to DSM-V criteria, both current or remitted
  • able to give informed consent and perform experimental tasks

排除标准

  • in remission of first (not chronic) episode or having a first (not chronic) current episode
  • insufficient comprehension of the Dutch language
  • physical, cognitive, or intellectual impairments interfering with participation such as deafness, blindness, or sensorimotor handicaps
  • formerly involved in MBCT or MBSR or other 8-week Mindfulness-Based Intervention (MBI)
  • meets criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective illness or anorexia nervosa
  • current psychosis
  • high level of suicidality
  • drug or alcohol addiction in the past 6 months.

结局指标

主要结局

Repetitive negative thinking (RNT)

时间窗: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

Measured by the Perseverative Thinking Questionnaire (PTQ). The PTQ consists of 15 items. Scores range from 0-60. Higher scores indicate a higher level of repetitive negative thinking.

Depressive rumination

时间窗: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

Measured with the brooding subscale of the Ruminative Response Scale (RRS). The brooding subscale consists of 5 items. Scores range from 5-20. Higher scores indicate a higher level of depressive rumination.

Depressive symptoms

时间窗: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)

Measured with the Inventory of Depressive Symptomatology Self-Report (IDS-SR). The IDS-SR consists of 30 items. Scores range from 0-84. Higher scores indicate a higher severity of depression.

次要结局

  • Intrusive thoughts (state measure)(Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks))
  • Overall functioning(Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks))
  • Mindfulness Skills(Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks))
  • Anxiety Symptoms(Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks))
  • Self-compassion(Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks))
  • Influence of Pavlovian information on goal-directed behaviour(Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks))
  • Working memory - emotion-dependent update and ignore capacity of working memory(Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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