Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design: Optimizing an Internet-delivered Cognitive Training Intervention to Reduce Anhedonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Dimensional Anhedonia Rating Scale (DARS)
研究概览
简要总结
This study is a small-scale randomized controlled trial (RCT) using a 'Leapfrog' design (Blackwell, Woud, Margraf, & Schönbrodt, 2019) with the aim of investigating feasibility of this design in the context of an RCT of an internet-delivered intervention. The leapfrog design will be applied to a simple cognitive training intervention, imagery cognitive bias modification (imagery CBM), completed over a four-week training period. The trial will start with the three arms described in the initial registration, but these will be removed and new arms added over the course of the trial on the basis of sequential Bayesian analyses.
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
- Single (Participant)
盲法说明
Participants are not blind as to whether they are receiving an intervention or monitoring only, but otherwise are blind to the status of which intervention they are receiving, i.e. 'original' version of the imagery CBM or an attempted improvement. Researchers are not blind to participant allocations, but the study is planned to be mostly automated, reducing opportunities to influence participants. Researchers will monitor performance of the arms as data accumulates, via the sequential analyses, and will therefore not be blind to outcomes as the trial progresses.
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
- •Aged 18 or over
- •Fluent German
- •Willing and able to complete all study procedures (including having a suitable device/ internet access)
- •Interested in monitoring their mood over the study time-period (one month)
- •Score of ≥ 6 on the Quick Inventory of Depressive Symptomatology, including ≥ 1 on item 13 (General Interest), indicating at least mild levels of depression symptoms and anhedonia
排除标准
- •No exclusion criteria set
结局指标
主要结局
Dimensional Anhedonia Rating Scale (DARS)
时间窗: Post-intervention (4 weeks post-baseline).
A 17-item scale measuring anhedonia (Rizvi et al., 2015). The primary analysis is a between-groups comparison of post-intervention scores, controlling for baseline scores, using constrained longitudinal data analysis (cLDA). An approximate Bayes factor is then calculated via the t-statistic for the Time x Group effect with a directional default Cauchy prior (rscale parameter = √2/2).
次要结局
- GAD-7(Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline))
- Quick Inventory of Depressive Symptomatology - Self Report (QIDS)(Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline))
- Positive Mental Health Scale (PMH)(Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline))
- Prospective Imagery Test (PIT)(Baseline and post-intervention (4 weeks post-baseline))
- Ambiguous Scenarios Test for Depression (AST)(Baseline and post-intervention (4 weeks post-baseline))
- Negative Effects Questionnaire - Short Form (NEQ)(Post-intervention (4 weeks post-baseline))
研究者
Simon Blackwell
Postdoctoral Researcher
Ruhr University of Bochum