Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
19 août 2019 mis à jour par: Brjann Ljotsson, Karolinska Institutet
The aim is to evaluate if internet- delivered CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will include 30 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
19
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Stockholm, Suède
- Department of Clinical Neuroscience, Karolinska Institutet
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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. -
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in The Atrial Fibrillation Quality of Life (AFEQT)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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WHODAS 2.0 (12-item version) •
Délai: 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) •
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Frieder Braunschweig, PhD, Karolinska Institutet
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2015
Achèvement primaire (Réel)
30 août 2018
Achèvement de l'étude (Réel)
30 août 2018
Dates d'inscription aux études
Première soumission
14 décembre 2015
Première soumission répondant aux critères de contrôle qualité
23 février 2016
Première publication (Estimation)
29 février 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 août 2019
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AF pilot ICBT 2015
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .