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Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

21 de septiembre de 2020 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

126

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Suecia
      • Stockholm, Suecia
        • Karolinska Universitetssjukhuset Solna

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Conductual: Internet-delivered cognitive behavior therapy
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.
Comparador de placebos: 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.
Conductual: Treatment as usual
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Atrial Fibrillation Quality of Life (AFEQT)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Electrocardiography (ECG) measurement
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: From baseline to 12 weeks
Symptom preoccupation
From baseline to 12 weeks
Cardiac Anxiety Questionary (CAQ)
Periodo de tiempo: From baseline to 6 months
Symptom preoccupation
From baseline to 6 months
Cardiac Anxiety Questionary (CAQ)
Periodo de tiempo: From baseline to 9 months
Symptom preoccupation
From baseline to 9 months
Cardiac Anxiety Questionary (CAQ)
Periodo de tiempo: 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)
Periodo de tiempo: From baseline to 12 weeks
General quality of life
From baseline to 12 weeks
WHODAS 2.0 (12-item version)
Periodo de tiempo: From baseline to 6 months
General quality of life
From baseline to 6 months
WHODAS 2.0 (12-item version)
Periodo de tiempo: From baseline to 15 months
General quality of life
From baseline to 15 months
Symptom checklist Severity and Frequency Scale (SCL)
Periodo de tiempo: From baseline to 12 weeks
AF related symptoms
From baseline to 12 weeks
Symptom checklist Severity and Frequency Scale (SCL)
Periodo de tiempo: From baseline to 6 months
AF related symptoms
From baseline to 6 months
Symptom checklist Severity and Frequency Scale (SCL)
Periodo de tiempo: From baseline to 15 months
AF related symptoms
From baseline to 15 months
Atrial Fibrillation Severity Scale
Periodo de tiempo: From baseline to 12 weeks
Symptomatic burden
From baseline to 12 weeks
Atrial Fibrillation Severity Scale
Periodo de tiempo: From baseline to 6 months
Symptomatic burden
From baseline to 6 months
Atrial Fibrillation Severity Scale
Periodo de tiempo: From baseline to 15 months
Symptomatic burden
From baseline to 15 months
Patient Health Questionnaire (PHQ-9)
Periodo de tiempo: From baseline to 12 weeks
Depression
From baseline to 12 weeks
PHQ-9
Periodo de tiempo: From baseline to 6 months
Depression
From baseline to 6 months
PHQ-9
Periodo de tiempo: From baseline to 15 months
Depression
From baseline to 15 months
Client satisfaction Questionnaire
Periodo de tiempo: From baseline to 12 weeks
Treatment satisfaction
From baseline to 12 weeks
Adverse events
Periodo de tiempo: From baseline to 12 weeks
Potential adverse reactions to the treatment
From baseline to 12 weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-rated health, 1 item
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From baseline to 6 months
Physical activity
From baseline to 6 months
The International Physical Activity Questionnaire
Periodo de tiempo: From baseline to 12 weeks
Physical activity
From baseline to 12 weeks
The International Physical Activity Questionnaire
Periodo de tiempo: From baseline to 9 months
Physical activity
From baseline to 9 months
The International Physical Activity Questionnaire
Periodo de tiempo: From baseline to 15 months
Physical activity
From baseline to 15 months
Body Sensation Questionnaire
Periodo de tiempo: From baseline to 12 weeks
Fear of bodily sensations
From baseline to 12 weeks
Body Sensation Questionnaire
Periodo de tiempo: From baseline to 6 months
Fear of bodily sensations
From baseline to 6 months
Body Sensation Questionnaire
Periodo de tiempo: From baseline to 15 months
Fear of bodily sensations
From baseline to 15 months
Anxiety Sensitivity Index
Periodo de tiempo: From baseline to 12 weeks
Anxiety sensitivity
From baseline to 12 weeks
Anxiety Sensitivity Index
Periodo de tiempo: From baseline to 6 months
Anxiety sensitivity
From baseline to 6 months
Anxiety Sensitivity Index
Periodo de tiempo: From baseline to 15 months
Anxiety sensitivity
From baseline to 15 months
Accelerometer
Periodo de tiempo: From baseline to 12 weeks
Objective measurement of physical activity 1 week
From baseline to 12 weeks
Accelerometer
Periodo de tiempo: From baseline to 6 months
Objective measurement of physical activity 1 week
From baseline to 6 months
Accelerometer
Periodo de tiempo: From baseline to 15 months
Objective measurement of physical activity 1 week
From baseline to 15 months
Perceived stress scale (4-item version)
Periodo de tiempo: From baseline to 12 weeks
Stress reactivity
From baseline to 12 weeks
Perceived stress scale (4-item version)
Periodo de tiempo: From baseline to 6 months
Stress reactivity
From baseline to 6 months
Perceived stress scale (4-item version)
Periodo de tiempo: From baseline to 9 months
Stress reactivity
From baseline to 9 months
Perceived stress scale (4-item version)
Periodo de tiempo: From baseline to 15 months
Stress reactivity
From baseline to 15 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Karolinska Institutet

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de enero de 2018

Finalización primaria (Actual)

20 de diciembre de 2019

Finalización del estudio (Actual)

20 de septiembre de 2020

Fechas de registro del estudio

Enviado por primera vez

11 de diciembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

18 de diciembre de 2017

Publicado por primera vez (Actual)

19 de diciembre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de septiembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2020

Última verificación

1 de septiembre de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AF RCT 1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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