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临床试验/NCT04137367
NCT04137367已完成不适用

A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination

University of Oslo1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2019年11月19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
108
试验地点
1
主要终点
Self-reported Depressive Symptoms: Becks Depression Inventory-II

研究概览

简要总结

This study evaluates the effect of a computerized intervention for depressive symptoms called Affective Bias Modification (ABM). A third of the patients will receive active ABM, a third will receive sham ABM and a third will undergo assessment only. The study will investigate if rumination mediates the effect of the intervention and investigate if specific symptom profiles affect the effect of the intervention.

详细描述

A main aim of the project is to investigate how the effects of an ABM intervention on depressive symptoms are mediated by transdiagnostic rumination and how characteristics of the symptom network moderate these effects. The Affective Bias Modification Task (ABM) will be applied in a randomized controlled, double blind clinical trial with 6 months follow-up. Personalized networks are generated from prospective assessment of depression-related processes at baseline and follow-ups. Patients (n = 150) will be recruited from out-patient clinics at Diakonhjemmet Hospital, and randomized into one of three conditions: active, sham and assessment only. Patients aged 18-65 with depression (major depressive disorder) or bipolar disorder 2, with or without comorbid anxiety and/or alcohol use disorder will be included. The main hypothesis is that subjects who are in the active ABM group will exhibit less tendency for stress related (state) rumination compared to those in the placebo group. Active vs placebo ABM will decrease depressive symptoms (6 months) and this effect will be mediated by the change in state rumination. Densely connected symptom network and high strength centrality of rumination at baseline will moderate the effect of ABM. By combining mechanisms research with a personalized symptom network approach, this study will be in the forefront of understanding how a drug-free treatment option works and for whom it works best.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Current or remitted Major Depressive Disorder, with or without anxiety, with or without alcohol use disorder

排除标准

  • •Neurological disorder, mania, and/or psychosis.

研究组 & 干预措施

Active Affective Bias Modification

Experimental

Computer based Affective Bias Modification

干预措施: Affective bias modification (Behavioral)

Sham Affective Bias Modification

Sham Comparator

Computer based sham Affective Bias Modification

干预措施: Sham Affective bias modification (Behavioral)

Assesment only

No Intervention

Only assessments are conducted

结局指标

主要结局

Self-reported Depressive Symptoms: Becks Depression Inventory-II

时间窗: At 6 months follow-up

Self-reported depressive symptoms 6 months after the ABM intervention based on a 21-item scale. Each item is scored 0-3 (where scoring description is adapted to each item), yielding a score from 0-63.

State Rumination: Brief State Rumination Inventory (BSRI)

时间窗: At baseline and two weeks follow up.

Change in self-reported state rumination after the stress induction from pre to post intervention on a 8 item scale. Difference score: BSRI post intervention - BRSI Baseline. A negative score means reduction in state rumination over the intervention. Each item is scored on a 0-100 Visual Analogue Scale. The total score divided by 8 to provide the mean item total score, hence the min= 0 and max = 100 for each of the BSRI assessment time points. It was hypothesized that change in state rumination over the intervention period would mediate the effect of ABM on depressive symptoms at six months follow up.

State Rumination: Brief State Rumination Inventory

时间窗: At two weeks follow up.

Self-reported state rumination after stress induction on a 8 item scale. Each item is scored on a 0-100 Visual Analogue Scale, yielding a score from 0-800, which is reported divided by 8 to provide a mean total item score. Hence the min= 0 and max = 100. A higher score indicates more state rumination.

次要结局

  • Affective Bias: Dot-probe Task(From baseline to two weeks follow up)
  • Symptom Network Change: Experience Sampling of Depressive Symptoms(From two weeks prior to baseline to two weeks after the two-week intervention.)
  • Symptom Network: Experience Sampling of Depressive Symptoms(Two weeks after the two-week intervention.)

研究者

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

Nils Inge Landrø

Professor

University of Oslo

研究点 (1)

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