Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
2020년 9월 21일 업데이트: Brjann Ljotsson, Karolinska Institutet
Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation - a Randomized Controlled Trial
The aim is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on exposure principles and behavioral activation, improves QoL and symptom burden in patients with symptomatic atrial fibrillation (AF) compared to treatment as usual.
The study will include 120 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
연구 개요
상세 설명
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 more than a wait list offered treatment as usual.
Method: A randomized controlled trial. Participants are randomized to internet-delivered CBT for 10 weeks (N=60) or to treatment as usual (N=60). The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls. Patients on the treatment as usual wait list will be provided standardized written information about basic self-management in AF. The treatment as usual wait list will be crossed over to treatment 3 months after the treatment group has completed treatment.
연구 유형
중재적
등록 (실제)
126
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Stockholm, 스웨덴
- Karolinska Universitetssjukhuset Solna
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 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) ; B) Age 18-75 years; C) On optimal medical treatment; D). Able to read and write in Swedish.
Exclusion Criteria:
- (E) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); (F) significant valvular disease; (G) planned ablation for AF or ablation within 3 months before assessment; (H) other severe medical illness; (I) any medical restriction to physical exercise; (J) severe psychiatric disorder, severe depression, or risk of suicide; (K) alcohol dependency.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Internet-delivered CBT over 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 aim 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.
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The intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention.
Include the guidance of a minimum weekly contact with a CBT psychologist.
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위약 비교기: Treatment as usual wait list
Patients randomized to the treatment as usual wait list arm will receive standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health.
Thus, the treatment as usual arm will control for the provision of basic patient information, but without the guidance of a psychologist or any CBT interventions.
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Consist of standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health, without the guidance of a psychologist or any CBT interventions.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Atrial Fibrillation Quality of Life (AFEQT)
기간: From baseline to 6 months PRIMARY ENDPOINT
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 6 months PRIMARY ENDPOINT
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The Atrial Fibrillation Quality of Life (AFEQT)
기간: From baseline to 12 weeks
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 12 weeks
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The Atrial Fibrillation Quality of Life (AFEQT)
기간: From baseline to 9 months
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 9 months
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The Atrial Fibrillation Quality of Life (AFEQT)
기간: From baseline to 15 months
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 15 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Electrocardiography (ECG) measurement
기간: From baseline to 12 weeks
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Change in symptomatic burden.
The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
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From baseline to 12 weeks
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ECG measurement
기간: From baseline to 6 months
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Change in symptomatic burden.
The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
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From baseline to 6 months
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ECG measurement
기간: From baseline to 15 months
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Change in symptomatic burden.
The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
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From baseline to 15 months
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Cardiac Anxiety Questionary (CAQ)
기간: From baseline to 12 weeks
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Symptom preoccupation
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From baseline to 12 weeks
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Cardiac Anxiety Questionary (CAQ)
기간: From baseline to 6 months
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Symptom preoccupation
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From baseline to 6 months
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Cardiac Anxiety Questionary (CAQ)
기간: From baseline to 9 months
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Symptom preoccupation
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From baseline to 9 months
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Cardiac Anxiety Questionary (CAQ)
기간: From baseline to 15 months
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Symptom preoccupation
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From baseline to 15 months
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the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)
기간: From baseline to 12 weeks
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General quality of life
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From baseline to 12 weeks
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WHODAS 2.0 (12-item version)
기간: From baseline to 6 months
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General quality of life
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From baseline to 6 months
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WHODAS 2.0 (12-item version)
기간: From baseline to 15 months
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General quality of life
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From baseline to 15 months
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Symptom checklist Severity and Frequency Scale (SCL)
기간: From baseline to 12 weeks
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AF related symptoms
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From baseline to 12 weeks
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Symptom checklist Severity and Frequency Scale (SCL)
기간: From baseline to 6 months
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AF related symptoms
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From baseline to 6 months
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Symptom checklist Severity and Frequency Scale (SCL)
기간: From baseline to 15 months
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AF related symptoms
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From baseline to 15 months
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Atrial Fibrillation Severity Scale
기간: From baseline to 12 weeks
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Symptomatic burden
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From baseline to 12 weeks
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Atrial Fibrillation Severity Scale
기간: From baseline to 6 months
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Symptomatic burden
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From baseline to 6 months
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Atrial Fibrillation Severity Scale
기간: From baseline to 15 months
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Symptomatic burden
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From baseline to 15 months
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Patient Health Questionnaire (PHQ-9)
기간: From baseline to 12 weeks
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Depression
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From baseline to 12 weeks
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PHQ-9
기간: From baseline to 6 months
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Depression
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From baseline to 6 months
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PHQ-9
기간: From baseline to 15 months
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Depression
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From baseline to 15 months
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Client satisfaction Questionnaire
기간: From baseline to 12 weeks
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Treatment satisfaction
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From baseline to 12 weeks
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Adverse events
기간: From baseline to 12 weeks
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Potential adverse reactions to the treatment
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From baseline to 12 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Self-rated health, 1 item
기간: From baseline to 12 weeks
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The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
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From baseline to 12 weeks
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Self-rated health, 1 item
기간: From baseline to 6 months
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The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
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From baseline to 6 months
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Self-rated health, 1 item
기간: From baseline to 15 months
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The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
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From baseline to 15 months
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Healthcare consumption and work loss:Tic-P
기간: From baseline to 12 weeks
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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).
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From baseline to 12 weeks
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Healthcare consumption and work loss:Tic-P
기간: From baseline to 6 months
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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).
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From baseline to 6 months
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Healthcare consumption and work loss:Tic-P
기간: From baseline to 15 months
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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).
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From baseline to 15 months
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The International Physical Activity Questionnaire
기간: From baseline to 6 months
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Physical activity
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From baseline to 6 months
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The International Physical Activity Questionnaire
기간: From baseline to 12 weeks
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Physical activity
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From baseline to 12 weeks
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The International Physical Activity Questionnaire
기간: From baseline to 9 months
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Physical activity
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From baseline to 9 months
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The International Physical Activity Questionnaire
기간: From baseline to 15 months
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Physical activity
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From baseline to 15 months
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Body Sensation Questionnaire
기간: From baseline to 12 weeks
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Fear of bodily sensations
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From baseline to 12 weeks
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Body Sensation Questionnaire
기간: From baseline to 6 months
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Fear of bodily sensations
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From baseline to 6 months
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Body Sensation Questionnaire
기간: From baseline to 15 months
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Fear of bodily sensations
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From baseline to 15 months
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Anxiety Sensitivity Index
기간: From baseline to 12 weeks
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Anxiety sensitivity
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From baseline to 12 weeks
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Anxiety Sensitivity Index
기간: From baseline to 6 months
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Anxiety sensitivity
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From baseline to 6 months
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Anxiety Sensitivity Index
기간: From baseline to 15 months
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Anxiety sensitivity
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From baseline to 15 months
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Accelerometer
기간: From baseline to 12 weeks
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Objective measurement of physical activity 1 week
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From baseline to 12 weeks
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Accelerometer
기간: From baseline to 6 months
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Objective measurement of physical activity 1 week
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From baseline to 6 months
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Accelerometer
기간: From baseline to 15 months
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Objective measurement of physical activity 1 week
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From baseline to 15 months
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Perceived stress scale (4-item version)
기간: From baseline to 12 weeks
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Stress reactivity
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From baseline to 12 weeks
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Perceived stress scale (4-item version)
기간: From baseline to 6 months
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Stress reactivity
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From baseline to 6 months
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Perceived stress scale (4-item version)
기간: From baseline to 9 months
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Stress reactivity
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From baseline to 9 months
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Perceived stress scale (4-item version)
기간: From baseline to 15 months
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Stress reactivity
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From baseline to 15 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 1월 8일
기본 완료 (실제)
2019년 12월 20일
연구 완료 (실제)
2020년 9월 20일
연구 등록 날짜
최초 제출
2017년 12월 11일
QC 기준을 충족하는 최초 제출
2017년 12월 18일
처음 게시됨 (실제)
2017년 12월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 9월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 9월 21일
마지막으로 확인됨
2020년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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