ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Change on Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
The study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy.
详细描述
The study is a 2 x 2 design. The first factor thought to be of relevance for the efficacy is the whether the content is selected by the participants themselves or by a therapist. The second factor consists of two levels: regular, continuous weekly support from a therapist or guidance on demand by a health care team consisting of a physician, a nurse, a clinical psychologist, an IT-technician and the principal investigator of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Current depressive symptoms equivalent to a score of at least 5 on Patient Health Questionnaire 9 and a minimum of 10 points on Becks Depression Inventory.
- •18 years or older.
- •Adequate ability to understand and speak Swedish.
- •Access to the internet and a smartphone/computer.
排除标准
- •Other ongoing psychological treatment or counselling.
- •Recent (within the past 3 months) changes in the dose of psychotropic medication.
- •Prior diagnosis of psychosis, bipolar disorder, or substance dependence.
结局指标
主要结局
Change on Patient Health Questionnaire (PHQ-9)
时间窗: Baseline, during week 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 of the intervention, post-intervention (after 11 weeks), 12 months after the end of intervention.
Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.
Change on Becks Depression Inventory-II (BDI-II)
时间窗: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item). Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 13-19, 20-28, and 29-63 points.
次要结局
- Change on Generalised Anxiety Disorder 7-item scale (GAD-7)(Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.)
- Change on Brunnsviken Brief Quality of Life Scale (BBQ)(Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.)
- Change on Insomnia Severity Index (ISI)(Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.)
研究者
Gerhard Andersson
Professor
Linkoeping University