CrisisCope: Internet-based CBT Intervention for Distress Related to Life Crises.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory-II
研究概览
简要总结
The aim with this study is to investigate the effects of internet-based cognitive behavioral therapy (ICBT) on psychological symptoms related to one or more life crises. The target group is adults (18 years or older) who have symptoms of depression, anxiety, stress, or other psychological distress related to one or more life crises. The ICBT consists of eight modules during eight weeks with weekly support by a therapist and the treatment group will be compared to a wait-list control condition. Participants will be recruited in Sweden with nationwide recruitment.
详细描述
The study is a randomized controlled trial about the effects of ICBT aiming to target psychological symptoms related to one or more life crises. Primary outcome measures are depressive symptoms (measured with Beck Depression inventory-II) and anxiety symptoms (measured with Generalized Anxiety Disorder-7). Other outcome measures used will for example be about adaptability, stress symptoms, sleep problems, post traumatic stress symptoms and quality of life.
Because the psychological impact of a life crisis can be diverse, between different people and between different kinds of crises, a transdiagnostic individually tailored treatment will be used that has been tested in several previous trials. This treatment has been adopted to target psychological symptoms related to life crises.
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
- 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
- •Experience psychological symptoms related to one or more life crises.
- •18 years or older
- •Adequate ability to speak, read and write Swedish
- •Having access to the internet and a smartphone, computer or other device
排除标准
- •Severe psychiatric or somatic issues that makes participation harder or impossible
- •Ongoing addiction
- •Acute suicidality
- •Other ongoing psychological treatment
- •Recent (within the past three months) changes in dose of psychotropic medication or planned change during the treatment weeks
结局指标
主要结局
Beck Depression Inventory-II
时间窗: Change between Baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Measure of depressive symptoms. Range for the total sum is between 0 and 63 with a higher score score indicating a higher level of depressive symptoms. Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 14-19, 20-28, and 29-63 respectively.
Generalized Anxiety Disorder-7
时间窗: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Measure of anxiety symptoms and worry. When summing the points of the seven first questions, the scores are interpreted as mild, moderate and severe anxiety symptoms at 5-10, 11-15, and above 15 respectively
次要结局
- Insomnia Severity Index(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Alcohol Use Disorder Identification Test(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- InCharge Financial Distress/Financial Well-Being Scale(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Impact of Events Scale-Revised(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Brief Adjustment Scale-6(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination. Also, every week during the treatment weeks.)
- Brunnsviken Brief Quality of Life Scale(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Perceived Stress Scale-14(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Posttraumatic Growths Inventory-Short form(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Patient Health Questionnaire-9(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Medical Outcome Study Social Support Survey(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
研究者
Gerhard Andersson
Professor
Linkoeping University