Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial
2019年12月13日 更新者：Erik Hedman、Karolinska Institutet
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering.
Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited.
One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression.
In the present study, we will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout syndrom in a randomized controlled trial (N=100).
Participants will be randomized to active treatment (n=50) or a control condition on waiting list.
研究概览
详细说明
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering.
Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited.
One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression.
Internet-based CBT can be described as online bibliotherapy with therapist support via a secure messaging system.
In this study psychologists will deliver the treatment.
We will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial (N=100).
Participants will be randomized to active treatment (n=50) or a control condition on waiting list.
We expect that participants who receive ICBT will make superior improvements compared to the control condition on measures of stress, burnout, depressive symptoms, general anxiety and general functioning.
研究类型
介入性
注册 (实际的)
100
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
To be included in the study participants must be between 18 and 65 years of age and suffer from primary stress-related disorders by meeting diagnostic criteria for adjustment disorder or burnout syndrome. Participants must have access to a computer and to the Internet, as well as being able to write and write in Swedish.
Exclusion Criteria:
Exclusion criteria include (a) meeting the criteria for another axis-1 diagnosis that is assessed to be the primary area of difficulty, (b) suffering from substance abuse/dependence in the past 6 months, (c) suffering from current or past psychosis or bipolar disorder, (d) moderate to high suicide risk, (e) initiated or changed pharmachological treatment for depression or anxiety in the past month and (f) other on-going psychological treatment for stress-related difficulties, and (g) not having received CBT for stress-related ill-health in the past year.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active treatment, Internet-based CBT
Internet-based treatment with therapist support using an asynchronous messaging system.
The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long.
The treatment is based on cognitive behavior therapy.
Participants will be stratified based on diagnosis, i.e. adjustment disorder and burnout.
|
Internet-based treatment with therapist support using an asynchronous messaging system.
The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long.
The treatment is based on cognitive behavior therapy
|
|
无干预：Waiting list control
The control condition is a waiting list.
Participants in this arm receive no active treatment.
After 12 weeks on waiting list, participants are crossed over to treatment.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Perceived stress scale (PSS)
大体时间：baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
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Change in PSS at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Shirlom Melamed Burnout Questionnaire (SMBQ)
大体时间：baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in SMBQ at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
|
Insomnia Severity Index (IS)
大体时间：baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in ISI at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
|
Generalized AnxietyDisorder-7 (GAD-7)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in GAD-7 at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Physical Health Questionnaire-15 (PHQ-15)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in PHQ-15 at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in MADRS-S at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Self-rated health (SRH)
大体时间：baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in SRH at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
|
Work Ability Index (WAI)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in WAI at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Euroqol 5 dimensions (EQ5D)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in EQ5D at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Brunnsviken Brief Quality of life inventory (BBQ)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in BBQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
World Health Organization Disability Assessment Schedule (WHODAS)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in WHODAS at post-treatment and follow-up compared to baseline.
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Alcohol Disorders Identification Test (AUDIT)
大体时间：Baseline
|
This instrument will be used for screening purpose only
|
Baseline
|
|
Sickness questionnaire state (SQ)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in SQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in TIC-P at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Karolinska Sleep Questionnaire (KSQ)
大体时间：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in KSQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Client Satisfaction Questionnaire (CSQ)
大体时间：Post-treatment (12 weeks)
|
Mean and standard deviations will be presented
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Post-treatment (12 weeks)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Credibility Scale (C-scale)
大体时间：Week 2 and week 8
|
Measures treatment credibility.
Mean scores and standard deviations will be presented
|
Week 2 and week 8
|
|
Change in Putative mediators
大体时间：week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Cost-Effectiveness of Therapist-Guided Internet-Based Cognitive Behavioral Therapy for Stress-Related Disorders: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2019 Sep 13;21(9):e14675. doi: 10.2196/14675.
- Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ejeby K, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Internet-Based Cognitive Behavioral Therapy for Chronic Stress: A Randomized Controlled Trial. Psychother Psychosom. 2018;87(5):296-305. doi: 10.1159/000490742. Epub 2018 Jul 24.
- Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年10月1日
初级完成 (实际的)
2017年10月1日
研究完成 (实际的)
2017年10月1日
研究注册日期
首次提交
2015年9月1日
首先提交符合 QC 标准的
2015年9月2日
首次发布 (估计)
2015年9月3日
研究记录更新
最后更新发布 (实际的)
2019年12月16日
上次提交的符合 QC 标准的更新
2019年12月13日
最后验证
2019年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.