Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Stockholm、瑞典
- Department of Clinical Neuroscience, Karolinska Institutet
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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.
Exclusion Criteria:
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. -
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Internet-based cognitive behavior therapy
10 sessions of ICBT during 10 weeks.
|
The CBT treatment lasts for 10 weeks and includes the following: Education on the role of anxiety on cardiac function and the effects of symptom preoccupation and avoidance QoL and depression in AF, creating a vicious cycle; exposure to physical sensations that are similar to AF symptoms (e.g.,palpitations due to physical activity or stress) to reduce fear of these symptoms; exposure to situations or activities previously avoided and abolishment of behaviors that fruitlessly aim to prevent triggering of AF episodes or to control symptoms; and behavioral activation aiming to increase social and physical activity and reduce depressive symptoms.
Therapist support is provided at least once weekly through the platform developed for the purpose.
Therapists are trained CBT-psychologists.
|
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 The Atrial Fibrillation Quality of Life (AFEQT)
大体时间：From baseline to 12 weeks
|
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
|
From baseline to 12 weeks
|
|
Change in The Atrial Fibrillation Quality of Life (AFEQT)
大体时间：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.
|
From baseline to 9 months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
WHODAS 2.0 (12-item version) •
大体时间：From baseline to 12 weeks.
|
Change in general quality of life
|
From baseline to 12 weeks.
|
|
WHODAS 2.0 (12-item version) •
大体时间：From baseline to 9 months.
|
Change in general quality of life:
|
From baseline to 9 months.
|
|
Symptom checklist (SCL)
大体时间：From baseline to 12 weeks.
|
Change in AF related symptoms:
|
From baseline to 12 weeks.
|
|
Symptom checklist (SCL)
大体时间：From baseline to 9 months.
|
Change in AF related symptoms:
|
From baseline to 9 months.
|
|
Atrial Fibrillation Severity Scale
大体时间：From baseline to 12 weeks.
|
Change in symptomatic burden
|
From baseline to 12 weeks.
|
|
Atrial Fibrillation Severity Scale
大体时间：From baseline to 9 months.
|
Change in symptomatic burden
|
From baseline to 9 months.
|
|
Cardiac Anxiety Questionnaire
大体时间：From baseline to 12 weeks.
|
Change in symptom preoccupation:
|
From baseline to 12 weeks.
|
|
Cardiac Anxiety Questionnaire
大体时间：From baseline to 9 months.
|
Change in symptom preoccupation
|
From baseline to 9 months.
|
|
GAD-7
大体时间：From baseline to 12 weeks.
|
Change in anxiety
|
From baseline to 12 weeks.
|
|
GAD-7
大体时间：From baseline to 9 months.
|
Change in anxiety
|
From baseline to 9 months.
|
|
PHQ-9
大体时间：From baseline to 12 weeks.
|
Change in depression:
|
From baseline to 12 weeks.
|
|
PHQ-9
大体时间：From baseline to 9 months.
|
Change in depression
|
From baseline to 9 months.
|
|
Perceived stress scale
大体时间：From baseline to 12 weeks.
|
Change in stress reactivity
|
From baseline to 12 weeks.
|
|
Perceived stress scale
大体时间：From baseline to 9 months.
|
Change in stress reactivity
|
From baseline to 9 months.
|
|
Change in healthcare consumption and work loss: TIC-P
大体时间：From baseline to 12 weeks.
|
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month.
These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
|
From baseline to 12 weeks.
|
|
Change in healthcare consumption and work loss: TIC-P
大体时间：From baseline to 9 months.
|
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month.
These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
|
From baseline to 9 months.
|
|
Change in symtomatic burden: Holter ECG.
大体时间：From baseline to 12 weeks.
|
The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
|
From baseline to 12 weeks.
|
|
Change in symptomatic burden: Holter ECG.
大体时间：From baseline to 9 months.
|
The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
|
From baseline to 9 months.
|
合作者和调查者
调查人员
- 研究主任：Frieder Braunschweig, PhD、Karolinska Institutet
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.