Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
21 settembre 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
126
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Stockholm, Svezia
- Karolinska Universitetssjukhuset Solna
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Atrial Fibrillation Quality of Life (AFEQT)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Electrocardiography (ECG) measurement
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Self-rated health, 1 item
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: From baseline to 15 months
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Stress reactivity
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From baseline to 15 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 gennaio 2018
Completamento primario (Effettivo)
20 dicembre 2019
Completamento dello studio (Effettivo)
20 settembre 2020
Date di iscrizione allo studio
Primo inviato
11 dicembre 2017
Primo inviato che soddisfa i criteri di controllo qualità
18 dicembre 2017
Primo Inserito (Effettivo)
19 dicembre 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 settembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 settembre 2020
Ultimo verificato
1 settembre 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AF RCT 1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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