Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
2020年9月21日 更新者：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.
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 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.
研究の種類
介入
入学 (実際)
126
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Stockholm、スウェーデン
- Karolinska Universitetssjukhuset Solna
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
|
実験的：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.
|
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.
|
|
プラセボコンパレーター：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.
|
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.
|
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 |
|---|---|---|
|
The Atrial Fibrillation Quality of Life (AFEQT)
時間枠：From baseline to 6 months PRIMARY ENDPOINT
|
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 6 months PRIMARY ENDPOINT
|
|
The Atrial Fibrillation Quality of Life (AFEQT)
時間枠：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
|
|
The Atrial Fibrillation Quality of Life (AFEQT)
時間枠：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
|
|
The Atrial Fibrillation Quality of Life (AFEQT)
時間枠：From baseline to 15 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 15 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Electrocardiography (ECG) measurement
時間枠：From baseline to 12 weeks
|
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")
|
From baseline to 12 weeks
|
|
ECG measurement
時間枠：From baseline to 6 months
|
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")
|
From baseline to 6 months
|
|
ECG measurement
時間枠：From baseline to 15 months
|
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")
|
From baseline to 15 months
|
|
Cardiac Anxiety Questionary (CAQ)
時間枠：From baseline to 12 weeks
|
Symptom preoccupation
|
From baseline to 12 weeks
|
|
Cardiac Anxiety Questionary (CAQ)
時間枠：From baseline to 6 months
|
Symptom preoccupation
|
From baseline to 6 months
|
|
Cardiac Anxiety Questionary (CAQ)
時間枠：From baseline to 9 months
|
Symptom preoccupation
|
From baseline to 9 months
|
|
Cardiac Anxiety Questionary (CAQ)
時間枠：From baseline to 15 months
|
Symptom preoccupation
|
From baseline to 15 months
|
|
the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)
時間枠：From baseline to 12 weeks
|
General quality of life
|
From baseline to 12 weeks
|
|
WHODAS 2.0 (12-item version)
時間枠：From baseline to 6 months
|
General quality of life
|
From baseline to 6 months
|
|
WHODAS 2.0 (12-item version)
時間枠：From baseline to 15 months
|
General quality of life
|
From baseline to 15 months
|
|
Symptom checklist Severity and Frequency Scale (SCL)
時間枠：From baseline to 12 weeks
|
AF related symptoms
|
From baseline to 12 weeks
|
|
Symptom checklist Severity and Frequency Scale (SCL)
時間枠：From baseline to 6 months
|
AF related symptoms
|
From baseline to 6 months
|
|
Symptom checklist Severity and Frequency Scale (SCL)
時間枠：From baseline to 15 months
|
AF related symptoms
|
From baseline to 15 months
|
|
Atrial Fibrillation Severity Scale
時間枠：From baseline to 12 weeks
|
Symptomatic burden
|
From baseline to 12 weeks
|
|
Atrial Fibrillation Severity Scale
時間枠：From baseline to 6 months
|
Symptomatic burden
|
From baseline to 6 months
|
|
Atrial Fibrillation Severity Scale
時間枠：From baseline to 15 months
|
Symptomatic burden
|
From baseline to 15 months
|
|
Patient Health Questionnaire (PHQ-9)
時間枠：From baseline to 12 weeks
|
Depression
|
From baseline to 12 weeks
|
|
PHQ-9
時間枠：From baseline to 6 months
|
Depression
|
From baseline to 6 months
|
|
PHQ-9
時間枠：From baseline to 15 months
|
Depression
|
From baseline to 15 months
|
|
Client satisfaction Questionnaire
時間枠：From baseline to 12 weeks
|
Treatment satisfaction
|
From baseline to 12 weeks
|
|
Adverse events
時間枠：From baseline to 12 weeks
|
Potential adverse reactions to the treatment
|
From baseline to 12 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-rated health, 1 item
時間枠：From baseline to 12 weeks
|
The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
|
From baseline to 12 weeks
|
|
Self-rated health, 1 item
時間枠：From baseline to 6 months
|
The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
|
From baseline to 6 months
|
|
Self-rated health, 1 item
時間枠：From baseline to 15 months
|
The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
|
From baseline to 15 months
|
|
Healthcare consumption and work loss:Tic-P
時間枠：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
|
|
Healthcare consumption and work loss:Tic-P
時間枠：From baseline to 6 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 6 months
|
|
Healthcare consumption and work loss:Tic-P
時間枠：From baseline to 15 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 15 months
|
|
The International Physical Activity Questionnaire
時間枠：From baseline to 6 months
|
Physical activity
|
From baseline to 6 months
|
|
The International Physical Activity Questionnaire
時間枠：From baseline to 12 weeks
|
Physical activity
|
From baseline to 12 weeks
|
|
The International Physical Activity Questionnaire
時間枠：From baseline to 9 months
|
Physical activity
|
From baseline to 9 months
|
|
The International Physical Activity Questionnaire
時間枠：From baseline to 15 months
|
Physical activity
|
From baseline to 15 months
|
|
Body Sensation Questionnaire
時間枠：From baseline to 12 weeks
|
Fear of bodily sensations
|
From baseline to 12 weeks
|
|
Body Sensation Questionnaire
時間枠：From baseline to 6 months
|
Fear of bodily sensations
|
From baseline to 6 months
|
|
Body Sensation Questionnaire
時間枠：From baseline to 15 months
|
Fear of bodily sensations
|
From baseline to 15 months
|
|
Anxiety Sensitivity Index
時間枠：From baseline to 12 weeks
|
Anxiety sensitivity
|
From baseline to 12 weeks
|
|
Anxiety Sensitivity Index
時間枠：From baseline to 6 months
|
Anxiety sensitivity
|
From baseline to 6 months
|
|
Anxiety Sensitivity Index
時間枠：From baseline to 15 months
|
Anxiety sensitivity
|
From baseline to 15 months
|
|
Accelerometer
時間枠：From baseline to 12 weeks
|
Objective measurement of physical activity 1 week
|
From baseline to 12 weeks
|
|
Accelerometer
時間枠：From baseline to 6 months
|
Objective measurement of physical activity 1 week
|
From baseline to 6 months
|
|
Accelerometer
時間枠：From baseline to 15 months
|
Objective measurement of physical activity 1 week
|
From baseline to 15 months
|
|
Perceived stress scale (4-item version)
時間枠：From baseline to 12 weeks
|
Stress reactivity
|
From baseline to 12 weeks
|
|
Perceived stress scale (4-item version)
時間枠：From baseline to 6 months
|
Stress reactivity
|
From baseline to 6 months
|
|
Perceived stress scale (4-item version)
時間枠：From baseline to 9 months
|
Stress reactivity
|
From baseline to 9 months
|
|
Perceived stress scale (4-item version)
時間枠：From baseline to 15 months
|
Stress reactivity
|
From baseline to 15 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年1月8日
一次修了 (実際)
2019年12月20日
研究の完了 (実際)
2020年9月20日
試験登録日
最初に提出
2017年12月11日
QC基準を満たした最初の提出物
2017年12月18日
最初の投稿 (実際)
2017年12月19日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月23日
QC基準を満たした最後の更新が送信されました
2020年9月21日
最終確認日
2020年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。