Internet-based Cognitive Behavioral Therapy for Psychological Symptoms Related to the COVID-19 Pandemic Remaining After Societal Opening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Generalized Anxiety Disorder-7
研究概览
简要总结
This study aim to investigate the effects of internet-based cognitive behavioral therapy (ICBT) addressing psychological symptoms related to the COVID-19 pandemic and its consequences that remain after societal opening. The target group is adults (18 years or older) who still experience psychological symptoms related to the pandemic and the ICBT consists of eight modules during eight week with weekly support by a therapist. ICBT 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 regarding psychological symptoms related to the COVID-19 pandemic and its consequences remaining after societal opening. Primary outcome measures are depression 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 stress symptoms, sleep problems, post traumatic stress symptoms and quality of life.
Because of uncertainties about the psychological effects of COVID-19 pandemic, a transproblematic individually tailored treatment will be used that has been tested in several previous trials and adapted for addressing problems related to the pandemic and its consequences. The study (nor the recruitment within it) has not a focus on whether people have or have not been infected by the COVID-19 virus.
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 mental health problems related to the COVID-19 pandemic and/or its consecuences, which are still experienced as a problem (when the pandemic is not considered as dangerous to the society)
- •18 years or older
- •Adequate ability to speak, read and write in 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 (which can include the diagnosis postcovid)
- •Ongoing addiction
- •Acute suicidality
- •Other ongoing psychological treatment
- •Recent (within the past 3 months) changes in the dose of psychotropic medication or planned change during the treatment weeks
结局指标
主要结局
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.
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
- Karolinska Exhaustion Disorder Scale 9(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Insonnia 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.)
- UCLA loneliness scale 3(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Percieved Stress Scale-14(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Short Health Anxiety Inventory-14(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- Impact of Event Scale-6(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
- The Cognitive Failures Questionnaire(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.)
- 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