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Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

21. september 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

126

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sverige
      • Stockholm, Sverige
        • Karolinska Universitetssjukhuset Solna

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Placebo komparator: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Atrial Fibrillation Quality of Life (AFEQT)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Karolinska Institutet

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. januar 2018

Primær færdiggørelse (Faktiske)

20. december 2019

Studieafslutning (Faktiske)

20. september 2020

Datoer for studieregistrering

Først indsendt

11. december 2017

Først indsendt, der opfyldte QC-kriterier

18. december 2017

Først opslået (Faktiske)

19. december 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AF RCT 1

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