Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in The Atrial Fibrillation Quality of Life (AFEQT)
研究概览
简要总结
The aim is to evaluate if internet- delivered CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will include 30 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
详细描述
Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. AF is associated with poor quality of life (QoL) and large costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF patients. Symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization.
The aim is to evaluate if CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.
Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) Paroxysmal AF ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. EHRA class ≥ IIb) [31]; B) Age 18-75 years; C) Able to read and write in Swedish.
排除标准
- •C) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); D) Significant valvular disease; E) Other severe medical illness; F) Severe depression or risk of suicide; G) Alcohol dependency. -
研究组 & 干预措施
Internet-based cognitive behavior therapy
10 sessions of ICBT during 10 weeks.
干预措施: Internet-based cognitive behavior therapy (Behavioral)
结局指标
主要结局
Change in The Atrial Fibrillation Quality of Life (AFEQT)
时间窗: From baseline to 9 months.
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
次要结局
- WHODAS 2.0 (12-item version) •(From baseline to 9 months.)
- Symptom checklist (SCL)(From baseline to 9 months.)
- Atrial Fibrillation Severity Scale(From baseline to 9 months.)
- Cardiac Anxiety Questionnaire(From baseline to 9 months.)
- GAD-7(From baseline to 9 months.)
- PHQ-9(From baseline to 9 months.)
- Perceived stress scale(From baseline to 9 months.)
- Change in healthcare consumption and work loss: TIC-P(From baseline to 9 months.)
- Change in symtomatic burden: Holter ECG.(From baseline to 12 weeks.)
- Change in symptomatic burden: Holter ECG.(From baseline to 9 months.)
研究者
Brjann Ljotsson
Associate professor, lic. psychologist
Karolinska Institutet