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临床试验/NCT04797273
NCT04797273已完成不适用

Internet-based Cognitive Behavior Therapy for Stress-related Disorders

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Perceived Stress Scale (PSS-10)

研究概览

简要总结

Stress-related mental illness is common and one of the main causes of sick leave in Sweden. Cognitive behavior therapy (CBT) is a promising treatment, but access to treatment is low. In a previously conducted study, we found that internet-based CBT in comparison to a waitlist control group was effective in reducing symptoms of stress. The aim of the present study is to take the next step and compare Internet-based CBT for stress-related disorders to an active control condition.

详细描述

Non traumatic stress-related mental illness, in this study operationalized as adjustment disorder or exhaustion disorder, is highly prevalent in the general population and associated with high societal costs relating to productivity loss. Cognitive behavior therapy (CBT) is the most well-studied psychological treatment and has demonstrated promising effects in terms of symptom reduction. The overall evidence-base for CBT for these disorders is however fairly week and access to treatment is low. In a previously published randomized controlled trial we found that internet-based CBT can yield large effects on core symptoms of stress for these disorders. Delivering CBT via the internet has the large advantage of enabling increased accessibility as each therapist can have up to 80 patients in ongoing treatment. In the previously conducted trial we compared the treatment to a waitlist control and between-group comparisons of treatment effects were only done at post-treatment as the waitlist condition was crossed over to treatment after this time point. It is now therefore important to take the next step and investigate the effects of internet-based CBT in comparison to an active control condition. The primary aim of this study was to compare two internet-based treatments, CBT vs. structured treatment-as-usual, for adjustment disorder and exhaustion disorder.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary adjustment disorder or exhaustion disorder
  • regular access to a computer and to the internet
  • ability to read and write in swedish

排除标准

  • substance abuse in the past 6 months
  • lifetime psychosis or bipolar disorder
  • suicide risk
  • initiated or changed psychopharmacological treatment for depression or anxiety in the past month
  • concurrent psychological treatment
  • cognitive behavior therapy for stress-related symptoms in the past year.

结局指标

主要结局

Perceived Stress Scale (PSS-10)

时间窗: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

Change in PSS at post-treatment and follow-ups compared to baseline (scale range 0-40, higher score means more symptoms)

次要结局

  • Shirom-Melamed Burnout Questionnaire (SMBQ)(Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • Montgomery-Åsberg Depression Rating Scale Self-report (MADRS-S)(Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • Sickness Questionnaire (SQ)(Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • World Health Organization's Disability Assessment Scale (WHODAS 2.0)(Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • Cognitive impairment(Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • Sick leave(1 year prior to baseline up to 2 years after baseline.)
  • Insomnia Severity Index (ISI)(Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • Self-rated Health (SRH)(Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • Generalized Anxiety Disorder-7 (GAD-7)(Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • EuroQol 5D (EQ5D 5L)(Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • Trimbos and Institute Medical Technology Assessment of Costs Questionnaire for Psychiatry (TIC-P)(Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up)
  • Physical Health Questionnaire (PHQ-15)(Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erik Hedman

Principal investigator

Karolinska Institutet

研究点 (2)

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