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Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

21. September 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

126

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Schweden
      • Stockholm, Schweden
        • Karolinska Universitetssjukhuset Solna

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The Atrial Fibrillation Quality of Life (AFEQT)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Andere Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Karolinska Institutet

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

8. Januar 2018

Primärer Abschluss (Tatsächlich)

20. Dezember 2019

Studienabschluss (Tatsächlich)

20. September 2020

Studienanmeldedaten

Zuerst eingereicht

11. Dezember 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Dezember 2017

Zuerst gepostet (Tatsächlich)

19. Dezember 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. September 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. September 2020

Zuletzt verifiziert

1. September 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AF RCT 1

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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