Tailored or Transdiagnostic ICBT with a Specific Therapist or Team Support: a Factorial Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 176
- 试验地点
- 3
- 主要终点
- Beck Anxiety Inventory
研究概览
简要总结
The purpose of this study is to investigate the differences in treatment outcomes between individually tailored and transdiagnostic internet-based cognitive behavioral therapy (ICBT), as well as the differences between weekly support by a specific therapist and weekly support by a team. The target group is adults (18 years or older) who experience mild to moderate depression symptoms, anxiety, stress or other psychological symptoms. The ICBT, in both types of treatment contents, consists of modules that the participants will work with for eight weeks in total. Participants will be recruited in Sweden with nationwide recruitment.
详细描述
This study is a factorial randomized controlled trial with the aim to investigate ICBT with two kinds of treatment contents and two kinds of support. Participants will either be randomized to an individually tailored treatment, where they will be selecting their own modules that they wish to work with, or be randomized to a transdiagnostic treatment, that consists of Unified Protocol that is developed by David Barlow and colleagues. Participants will also be randomized to either get weekly support by one specific therapist or get support by "a team", meaning that the participant will get support from different therapists each week. In both kinds of support, the participant will have the opportunity to ask for support during the other times of the week as well.
Primary outcome measures are depression symptoms (measured with Beck Depression Inventory-II) and anxiety symptoms (measured with Beck Anxiety Inventory). Other, secondary, outcome measures used will for example be about stress symptoms, insomnia symptoms, and quality of life. Pre-treatment measurement, post-treatment measurement and one-year follow up is planned to be collected through an online survey.
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 mild to moderate psychological symptoms or problems
- •18 years or older
- •Ability to speak, read and write in Swedish
- •Have access to the internet and a smartphone, computer or other device
排除标准
- •Severe psychiatric or somatic illness that makes participation harder or impossible
- •Ongoing addiction
- •Acute suicidality
- •Other ongoing psychological treatment
- •Recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks
结局指标
主要结局
Beck Anxiety Inventory
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, consisting of 21 items. Range for the total sum is between 0 and 63, interpreted as minimal anxiety (0-7), mild anxiety (8-15), moderate anxiety (16-25) and severe anxiety (26-63).
Becks 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 indicating a higher level of depressive symptoms. 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 respectively.
次要结局
- Rosenberg's Self-esteem 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.)
- Brunnsviken Brief Quality of Life Scale(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Patient Health Questionnaire-15(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- 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.)
- Goldberg's (1999) IPIP representation of Costa McCrae's (1992) NEO-PI-R Domains(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.)
研究者
Gerhard Andersson
Professor
Linkoeping University