Establishing a Dose-response Relationship for the Effects of a Cognitive Control Training on Depression Vulnerability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Change in Beck Depression Inventory (BDI-II-NL)
研究概览
简要总结
This study aims to examine the dose-response relationship of an online adaptive cognitive control training on depressive symptomatology and rumination. Participants will be randomized over six groups, each receiving a different dose (0, 1, 5, 10, 15 or 20 sessions) of a cognitive control training in remitted depressed patients. An adaptive Paced Auditory Serial Addition Task will be used as cognitive control training.
详细描述
Depression is often associated with cognitive impairments and recent studies have found that for some people, these cognitive problems persist after remission of depression. These cognitive impairments could be a risk factor for recurrence of depressive episodes. Cognitive control training aims to address these cognitive impairments and decrease the risk of recurrence of depression.
One promising operationalization of cognitive control training is the adaptive Paced Auditory Serial Addition Task, but currently, it's unclear how many sessions one should complete in order to obtain cognitive- and emotional transfer effects. By comparing multiple groups with a different number of sessions (0, 1, 5, 10, 15 and 20), with measures at post (one month after baseline) and two follow-up periods (at 3 months and 6 months after baseline), this study examines the effects of an online cognitive control training on depressive vulnerability factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 是
入选标准
- •History of ≥ 1 depressive episode(s)
- •Currently in remission (≥ 3 months)
- •Access to a computer with an internet connection
排除标准
- •Ongoing depressive episode
- •Psychotic disorder (current and/or previous)
- •Neurological impairments (current and/or previous)
- •Excessive substance abuse (current and/or previous)
- •Use of antidepressant medication is allowed if kept at a constant level
研究组 & 干预措施
Intervention group
Cognitive control training: The adaptive Paced Auditory Serial Addition Task (aPASAT) is a Cognitive Control Training where participants need to click on the sum of the last two heard digits. Task difficulty is modified based on the participants' current task performance, allowing training of cognitive control. Five intervention groups will each receive a different amount of sessions.
干预措施: Cognitive control training (Behavioral)
Control group
Waitlist control group: Participants randomized to the control group will not perform the cognitive control training during the study, but will be given the opportunity to follow the training afterwards.
结局指标
主要结局
Change in Beck Depression Inventory (BDI-II-NL)
时间窗: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Self-report questionnaire with 21 items, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.
次要结局
- Change in Perseverative Thinking Questionnaire (PTQ-NL)(baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline)
- Change in Cognitive Emotion Regulation Questionnaire (CERQ)(baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline)
- Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale(baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline)
- Change in Burnout Assessment Tool (BAT)(baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline)
- Change in Remission from Depression Questionnaire (RDQ-NL)(baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline)
- Change in non-adaptive PASAT performance(baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline)
- Change in n-back performance(baseline, post training (one month after baseline))