Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Stockholm、スウェーデン
- Department of Clinical Neuroscience, Karolinska Institutet
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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. -
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in The Atrial Fibrillation Quality of Life (AFEQT)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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WHODAS 2.0 (12-item version) •
時間枠：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) •
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Frieder Braunschweig, PhD、Karolinska Institutet
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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