Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
21 września 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
126
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Stockholm, Szwecja
- Karolinska Universitetssjukhuset Solna
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 75 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Komparator placebo: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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The Atrial Fibrillation Quality of Life (AFEQT)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Electrocardiography (ECG) measurement
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Self-rated health, 1 item
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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From baseline to 15 months
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Healthcare consumption and work loss:Tic-P
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).
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From baseline to 15 months
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The International Physical Activity Questionnaire
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: From baseline to 9 months
|
Stress reactivity
|
From baseline to 9 months
|
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Perceived stress scale (4-item version)
Ramy czasowe: From baseline to 15 months
|
Stress reactivity
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From baseline to 15 months
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
8 stycznia 2018
Zakończenie podstawowe (Rzeczywisty)
20 grudnia 2019
Ukończenie studiów (Rzeczywisty)
20 września 2020
Daty rejestracji na studia
Pierwszy przesłany
11 grudnia 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
18 grudnia 2017
Pierwszy wysłany (Rzeczywisty)
19 grudnia 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
23 września 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 września 2020
Ostatnia weryfikacja
1 września 2020
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AF RCT 1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Internet-delivered cognitive behavior therapy
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