Using Bayesian Sequential Single Case Methodology to Personalize Low-Intensity Psychological Interventions for Depression: Initial Pilot Work
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Quick Inventory of Depressive Symptomatology - Self Report Daily Version (QIDS-daily)
研究概览
简要总结
The study is an initial investigation of the feasibility of applying Bayesian sequential analyses to individual participant single-case data for rapid detection of whether or not the individual is benefitting from a low-intensity computerized cognitive training intervention for depression. Patients waiting for, or in follow-up from, outpatient psychological therapy will complete first a two-week period of daily symptom monitoring, followed by two different two-week cognitive training interventions. Data collected will be used to assess feasibility of a future formal case series using Bayesian sequential analyses to determine switching of interventions, and inform the analysis parameters for such a future study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Two active interventions are used, and both participants and researchers are aware of which intervention participants are completing.
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
- •Patient registered at the Ruhr University of Bochum Outpatient Psychotherapy Center ("Zentrum für Psychotherapie", ZPT) in an appropriate phase of treatment (on waiting list/ in follow-up), or from 26/10/22 having had a first consultation ("Beratungsgespräch")
- •Aged 18 years or above
- •Owning a technical device (e.g. a laptop, computer) that is compatible with the computerized training
- •Scoring ≥ 6 on the QIDS (indicating at least mild levels of depressive symptoms)
- •Willing and able to complete all study procedures
排除标准
- •Existence of a condition or circumstances that would interfere with completion of the study procedures (e.g. severe visual impairment, neurological problem, acute psychosis, or substance withdrawal symptoms)
- •Acute crisis with high levels of suicidal ideations or high levels of self-harm, identified either through therapist's assessment or score >1 on item 12 of the QIDS
结局指标
主要结局
Quick Inventory of Depressive Symptomatology - Self Report Daily Version (QIDS-daily)
时间窗: End of intervention (4 weeks post-baseline)
The QIDS-daily is an adapted version of the QIDS-SR (Rush et al., 2003), which asks about symptoms over the past day and does not include the weight gain/loss items (as used by Holmes et al., 2016). The QIDS-daily will be completed daily over the entire study period, and we will compare the mean and slope of the daily QIDS over the intervention phase to the mean and slope of the daily QIDS in the previous phase.
次要结局
- GAD-7(Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline))
- Daily Expressions of Psychopathology (DEP)(End of intervention (4 weeks post-baseline))
- Prospective Imagery Test (PIT)(Baseline, end of study (6 weeks post-baseline))
- Quick Inventory of Depressive Symptomatology - Self Report (QIDS)(Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline))
- Positive and Negative Affect Schedule - Positive subscale (PANAS-P)(Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline))
- Positive Mental Health Scale (PMH)(Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline))
- Dimensional Anhedonia Rating Scale (DARS)(Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline))
研究者
Simon Blackwell
Postdoctoral Researcher
Ruhr University of Bochum