Internet-delivered Cognitive Behaviour Therapy for Anxiety Related to Asthma: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Catastrophizing about asthma Scale
研究概览
简要总结
This is a randomized controlled trial to investigate efficacy of a internet-delivered CBT for anxiety related to asthma.
详细描述
Asthma is one of the most common chronic diseases and is often associated with anxiety. In a two prior studies (ClinicalTrials.gov ID: NCT03158194; NCT03486756) a protocol for exposure-based cognitive behaviour therapy (CBT) for anxiety related to asthma was developed, and standardised to an internet-delivered format and tested for feasibility and acceptability as an internet-CBT. The aim of the current study is to evaluate the efficacy of exposure-based Internet-CBT for anxiety related to asthma compared to Treatment as Usual (TAU). The plan is to include 90 participants consecutively during 2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All assessments will be conducted by participants over the internet, why there can be no influence from study staff during data collection.
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
- •asthma diagnosed by a physician
- •worry about asthma or limitations in daily life due to asthma at
排除标准
- •a serious psychiatric condition; e.g., suicidality, psychosis or severe substance addiction
- •chronic obstructive pulmonary disease (COPD) or other chronic airway disorders other than asthma
结局指标
主要结局
Catastrophizing about asthma Scale
时间窗: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Change in catastrophizing cognitions about asthma measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
次要结局
- Asthma Behaviour Checklist(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Insomnia Severity Index(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Patient Health Questionnaire-9(Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Penn State Worry Questionnaire(Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Asthma Quality of Life Questionnaire(Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Perceived Stress Scale(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Asthma control test(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Fear of Asthma Symptoms(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Asthma Tuner(Time Frame: Baseline to 8 weeks; baseline to16 weeks.)
- Short Health Anxiety Inventory (SHAI)(Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
- WHODAS(Time Frame: Baseline to 8 weeks; Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Brunnsviken quality of life scale(Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.)
- Treatment Inventory of Costs in Patients(Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.)
研究者
Catarina Almqvist Malmros
Professor, MD
Karolinska Institutet