Effects and Mechanisms of Change of Two Different Treatments Targeting Worry in Generalised Anxiety Disorder: Study 1 - IU Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Generalized Anxiety Disorder 7-item (GAD7)
研究概览
简要总结
The goal of this clinical is to pilot test an internet delivered cognitive behavior therapy (ICBT) based on intolerance of uncertainty (one of several existing specific cognitive models for how worry works) in treating generalised anxiety disorder (GAD). The main aims is to:
- Test the preliminary effect of the intervention in lowering symptoms of GAD as measured by the self report scale GAD-7
- Test procedures for recruitment, assessment, treatment and follow up
- Test the acceptability of the intervention as measured by the Client Satisfaction questionnaire-8, dropout and adverse events
Participants will apply for treatment in an online system, be assessed via video by a licensed clinical psychologist and then receive a 10 week long ICBT intervention based on the intolerance of uncertainty model. This is a pilot study for an upcoming randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18 years old or more.
- •Diagnosis of GAD based on clinical assessment.
- •At least 10 points on GAD-7 at screening.
- •Proficient in written Swedish.
- •Access to internet enabled device and Swedish BankID for authentication
- •Able to make sufficient time for the 10 week long treatment
- •Consents to study
排除标准
- •In need of treatment for other psychiatric diagnosis as priority (eg depression, psychosis) or high risk of suicide based on clinical assessment
- •Ongoing risk use of alcohol or drugs
- •Ongoing serious somatic of social disease/problem that is deemed to be to much of a hindrance for the completion of the treatment
结局指标
主要结局
Generalized Anxiety Disorder 7-item (GAD7)
时间窗: 10 weeks after treatment start
Symptoms of generalized anxiety disorder measured by the self report measure GAD7. Scores range from 0-21 with higher scores indicating more generalized anxiety
次要结局
- Treatment credibility(2 weeks into treatment)
- Satisfaction with treatment(10 weeks after treatment start)
- Intolerance of uncertainty(10 weeks after treatment start)
- Symptoms of depression(10 weeks after treatment start)
- WHO Disability Assessment Schedule (WHODAS 2.0) self report (12 items)(10 weeks after treatment start)
- Symptoms of depression including suicidal ideation(10 weeks after treatment start)
- Excessive worry(10 weeks after treatment start)
研究者
Erik Forsell
Principal Investigator
Karolinska Institutet