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Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

21 de setembro de 2020 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

126

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Suécia
      • Stockholm, Suécia
        • Karolinska Universitetssjukhuset Solna

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The Atrial Fibrillation Quality of Life (AFEQT)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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 resultados secundários

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

Outras medidas de resultado

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Karolinska Institutet

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de janeiro de 2018

Conclusão Primária (Real)

20 de dezembro de 2019

Conclusão do estudo (Real)

20 de setembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

11 de dezembro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de dezembro de 2017

Primeira postagem (Real)

19 de dezembro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de setembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de setembro de 2020

Última verificação

1 de setembro de 2020

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AF RCT 1

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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