Cognitive Remediation Following Electroconvulsive Therapy in Patients with Treatment Resistant Depression: Randomized Controlled Trail of an Intervention for Relapse Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in severity of depressive symptoms, clinician-rated (HAM-D)
研究概览
简要总结
Major depressive disorder (MDD) is worldwide one of the most prevalent and disabling mental health conditions. Electroconvulsive therapy (ECT) is a safe and effective treatment even though 6-month relapse rates are high. Cognitive side effects of ECT, such as reduced cognitive control, might trigger mechanisms that increase relapse in patients. As such, cognitive control training (CCT) holds promise as a non-pharmacological strategy to improve long-term effects of ECT (i.e., increase remission, and reduce depression relapse).
详细描述
Eighty-eight participants aged between 18-70 years with major depressive disorder who start electroconvulsive treatment (ECT) will be included in this randomized controlled trial (RCT). Following (partial) response to ECT treatment (at least a 25% reduction of clinical symptoms), participants will be randomly assigned to a computer based CCT or active placebo control. A first aim of this RCT is to assess the effects of CCT compared to an active placebo condition on depression symptomatology, cognitive complaints, and quality of life. Secondly, participants will be monitored every two weeks for a period of six months following CCT/active placebo, allowing the detection of potential relapse of depression. Thirdly, the investigators will assess participant evaluation of the addition of cognitive remediation to ECT using qualitative interview methods (satisfaction, acceptability and appropriateness). Finally, in order to further advance our understanding of the mechanisms underlying effects of CCT, exploratory analyses may be conducted using facial video footage collected during the CCT/active control phase of the study.
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 (Participant, Outcomes Assessor)
盲法说明
Upon registration in the computer-based training, the computer will randomly allocate participants to either cognitive control training or placebo condition.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 70 years old
- •current major depressive episode with treatment resistance
- •eligibility and consent for ECT treatment
- •ability to provide consent to study
排除标准
- •neurodegenerative disorder or MOCA < 18
- •catatonia
- •schizophrenia
- •alcohol use disorder in previous year
- •prior ECT treatment
- •insufficient computer knowledge or analphabetism
研究组 & 干预措施
Cognitive control training
Cognitive Control Training (CCT) makes use of a very basic cognitive task that strongly loads on working memory and cognitive control processes, namely the adaptive Paced Auditory Serial Addition Task (aPASAT) where participants are given a number every 3 seconds and are asked to add the number they just heard with the number they heard before. Task difficulty is modified based on the participants current task performance, allowing training of cognitive control. Participants in the intervention group will start the CCT training after completion of ECT with a maximum time interval of 7 days. Training sessions will be performed on a tablet or computer and participants will complete five sessions per week (20 minutes per session) for a period of two weeks.
干预措施: Cognitive Control Training (Behavioral)
Active Control
Participants in the active control group will start placebo training after completion of ECT with a maximum time interval of 7 days. The placebo task consists of a task similar to the experimental condition but that does not train cognitive control. Prior research confirmed that this condition controls for non-specific effects of the training and motivational issues. Participants will perform the sessions on a tablet or computer and complete five sessions per week (20 minutes per session) for a period of two weeks.
干预措施: Active Control (Behavioral)
结局指标
主要结局
Change in severity of depressive symptoms, clinician-rated (HAM-D)
时间窗: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
The Hamilton Depression Rating Scale (HAM-D) is a clinician rated questionnaire with 17 items scored on a three or five-point Likert-type scale. Amongst other symptoms of depression, items include mood, insomnia and suicidal ideations. Higher scores indicate increased severity of depression with a maximum score of 50 and minimum of 0.
Change in depressive symptoms and quality of life, self-reported (RDQ)
时间窗: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
The Remission from Depression Questionnaire (RDQ) will inform about seven domains: symptoms of depression, non-depressive symptoms, features of positive mental health, coping ability, functioning, life satisfaction and a general sense of well-being. The RDQ is a 41-item questionnaire. Higher scores indicate increased severity of depression. Minimum score is 0 and 82 is the maximum score.
Change in severity of depressive symptoms, self-reported (BDI-II)
时间窗: 1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion
The Beck Depression Inventory (BDI-II) is a 21-item self-report questionnaire regarding symptoms of depression with good validity and reliability. Higher scores indicate increased severity of depression. Minimum score is 0 and 63 is the maximum score.
次要结局
- Time to relapse(Up to 6 months monitoring)
- Cognition (Paced Auditory Serial Addition Task - PASAT)(1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion and 6 months after ECT completion)
- Facial features from video footage(2 weeks during CCT or placebo intervention)
- Quality of Life in Depression Scale (QLDS)(1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion)
- Rumination (RRS-10)(1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion)
- Cognition (CANTAB)(1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion)
- Acceptability and satisfaction(1 - 30 days after CCT training completion)
- Subjective memory complaints (SSMQ)(1-7 days before first ECT session, 1-7 days post ECT completion, 1-7 days after intervention/placebo completion, 3 months after ECT completion, and 6 months after ECT completion)