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临床试验/NCT04424212
NCT04424212
已完成
不适用

CoronaCope - Internet-based Cognitive Behavioural Therapy for Adults Suffering From Mental Health Problems Related to the Coronavirus Pandemic

Linkoeping University1 个研究点 分布在 1 个国家目标入组 76 人2020年6月10日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Depression and Quality of Life Related to the Coronavirus Pandemic
发起方
Linkoeping University
入组人数
76
试验地点
1
主要终点
Becks Depression Inventory-II
状态
已完成
最后更新
4年前

概览

简要总结

The study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme a on adult mental health problems related to the current coronavirus pandemic. ICBT will be compared to a wait-list control group.

Participants will be recruited in Sweden with a nationwide recruitment.

详细描述

The study is set up as a randomized controlled trial. Quality of life, depressive symptoms, anxiety, sleep problems and traumatic stress will be measured. Given uncertainties regarding the psychological effects of Covid-19 pandemic a transproblematic tailored treatment approach will be used that has been tested in several previous trials. However, the present program has been adapted for the target population of people who are affected by the societal and individual consequences of the pandemic. The study does not focus on people who have or have had the corona virus.

注册库
clinicaltrials.gov
开始日期
2020年6月10日
结束日期
2021年10月1日
最后更新
4年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Linkoeping University
责任方
Principal Investigator
主要研究者

Gerhard Andersson

Professor

Linkoeping University

入排标准

入选标准

  • Experience mental health problems that are caused or exacerbated by the corona pandemic and/or its consequences
  • 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 that interfere with trial treatment.
  • Recent (within the past 3 months) changes in the dose of psychotropic medication.
  • Any severe psychiatric or somatic conditions that would interfere with trial treatment

结局指标

主要结局

Becks Depression Inventory-II

时间窗: Change between baseline and end of treatment after seven weeks.

Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item) 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.

Brunnsviken Brief Quality of Life Scale

时间窗: Change between baseline and end of treatment after seven weeks.

Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.

次要结局

  • Alcohol Use Disorder Identification Test(Change between baseline and end of treatment after seven weeks.)
  • Insomnia Severity Index(Change between baseline and end of treatment after seven weeks.)
  • The CoRonavIruS Health Impact Survey(At baseline)
  • Becks Depression Inventory-II(Change between posttreatment and 12-month follow-up.)
  • Brunnsviken Brief Quality of Life Scale(Change between posttreatment and 12-month follow-up.)
  • Patient Health Questionnaire(Change between baseline and end of treatment after seven weeks.)
  • Impact of Event Scale-Revised(Change between baseline and end of treatment after seven weeks.)
  • Dimensions of Anger Reactions (DAR-5) Questionnaire(Change between posttreatment and 12-month follow-up.)
  • Perceived Stress Scale(Change between baseline and end of treatment after seven weeks.)

研究点 (1)

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