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Internet-based Cognitive Behavior Therapy for Atrial Fibrillation

19. august 2019 opdateret af: 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.

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.

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

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
        • Department of Clinical Neuroscience, Karolinska Institutet

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:

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. -

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Internet-based cognitive behavior therapy
10 sessions of ICBT during 10 weeks.
Adfærdsmæssigt: Internet-based cognitive behavior therapy
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 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
Change in 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
WHODAS 2.0 (12-item version) •
Tidsramme: From baseline to 12 weeks.
Change in general quality of life
From baseline to 12 weeks.
WHODAS 2.0 (12-item version) •
Tidsramme: From baseline to 9 months.
Change in general quality of life:
From baseline to 9 months.
Symptom checklist (SCL)
Tidsramme: From baseline to 12 weeks.
Change in AF related symptoms:
From baseline to 12 weeks.
Symptom checklist (SCL)
Tidsramme: From baseline to 9 months.
Change in AF related symptoms:
From baseline to 9 months.
Atrial Fibrillation Severity Scale
Tidsramme: From baseline to 12 weeks.
Change in symptomatic burden
From baseline to 12 weeks.
Atrial Fibrillation Severity Scale
Tidsramme: From baseline to 9 months.
Change in symptomatic burden
From baseline to 9 months.
Cardiac Anxiety Questionnaire
Tidsramme: From baseline to 12 weeks.
Change in symptom preoccupation:
From baseline to 12 weeks.
Cardiac Anxiety Questionnaire
Tidsramme: From baseline to 9 months.
Change in symptom preoccupation
From baseline to 9 months.
GAD-7
Tidsramme: From baseline to 12 weeks.
Change in anxiety
From baseline to 12 weeks.
GAD-7
Tidsramme: From baseline to 9 months.
Change in anxiety
From baseline to 9 months.
PHQ-9
Tidsramme: From baseline to 12 weeks.
Change in depression:
From baseline to 12 weeks.
PHQ-9
Tidsramme: From baseline to 9 months.
Change in depression
From baseline to 9 months.
Perceived stress scale
Tidsramme: From baseline to 12 weeks.
Change in stress reactivity
From baseline to 12 weeks.
Perceived stress scale
Tidsramme: From baseline to 9 months.
Change in stress reactivity
From baseline to 9 months.
Change in 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.
Change in healthcare consumption and work loss: TIC-P
Tidsramme: From baseline to 9 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 9 months.
Change in symtomatic burden: Holter ECG.
Tidsramme: From baseline to 12 weeks.
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")
From baseline to 12 weeks.
Change in symptomatic burden: Holter ECG.
Tidsramme: From baseline to 9 months.
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")
From baseline to 9 months.

Samarbejdspartnere og efterforskere

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

Sponsor

Karolinska Institutet

Efterforskere

  • Studieleder: Frieder Braunschweig, PhD, Karolinska Institutet

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. december 2015

Primær færdiggørelse (Faktiske)

30. august 2018

Studieafslutning (Faktiske)

30. august 2018

Datoer for studieregistrering

Først indsendt

14. december 2015

Først indsendt, der opfyldte QC-kriterier

23. februar 2016

Først opslået (Skøn)

29. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AF pilot ICBT 2015

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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