Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
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.
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Stockholm, 스웨덴
- Department of Clinical Neuroscience, Karolinska Institutet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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. -
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Internet-based cognitive behavior therapy
10 sessions of ICBT during 10 weeks.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in 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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Change in 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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WHODAS 2.0 (12-item version) •
기간: From baseline to 12 weeks.
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Change in 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 9 months.
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Change in general quality of life:
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From baseline to 9 months.
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Symptom checklist (SCL)
기간: From baseline to 12 weeks.
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Change in AF related symptoms:
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From baseline to 12 weeks.
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Symptom checklist (SCL)
기간: From baseline to 9 months.
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Change in AF related symptoms:
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From baseline to 9 months.
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Atrial Fibrillation Severity Scale
기간: From baseline to 12 weeks.
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Change in symptomatic burden
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From baseline to 12 weeks.
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Atrial Fibrillation Severity Scale
기간: From baseline to 9 months.
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Change in symptomatic burden
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From baseline to 9 months.
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Cardiac Anxiety Questionnaire
기간: From baseline to 12 weeks.
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Change in symptom preoccupation:
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From baseline to 12 weeks.
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Cardiac Anxiety Questionnaire
기간: From baseline to 9 months.
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Change in symptom preoccupation
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From baseline to 9 months.
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GAD-7
기간: From baseline to 12 weeks.
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Change in anxiety
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From baseline to 12 weeks.
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GAD-7
기간: From baseline to 9 months.
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Change in anxiety
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From baseline to 9 months.
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PHQ-9
기간: From baseline to 12 weeks.
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Change in depression:
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From baseline to 12 weeks.
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PHQ-9
기간: From baseline to 9 months.
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Change in depression
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From baseline to 9 months.
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Perceived stress scale
기간: From baseline to 12 weeks.
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Change in stress reactivity
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From baseline to 12 weeks.
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Perceived stress scale
기간: From baseline to 9 months.
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Change in stress reactivity
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From baseline to 9 months.
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Change in 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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Change in healthcare consumption and work loss: TIC-P
기간: From baseline to 9 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 9 months.
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Change in symtomatic burden: Holter ECG.
기간: From baseline to 12 weeks.
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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")
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From baseline to 12 weeks.
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Change in symptomatic burden: Holter ECG.
기간: From baseline to 9 months.
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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")
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From baseline to 9 months.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Frieder Braunschweig, PhD, Karolinska Institutet
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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