Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
19. august 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
19
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Stockholm, Sverige
- Department of Clinical Neuroscience, Karolinska Institutet
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Internet-based cognitive behavior therapy
10 sessions of ICBT during 10 weeks.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in The Atrial Fibrillation Quality of Life (AFEQT)
Tidsramme: From baseline to 12 weeks
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 12 weeks
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Change in The Atrial Fibrillation Quality of Life (AFEQT)
Tidsramme: From baseline to 9 months.
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 9 months.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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WHODAS 2.0 (12-item version) •
Tidsramme: From baseline to 12 weeks.
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Change in general quality of life
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From baseline to 12 weeks.
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WHODAS 2.0 (12-item version) •
Tidsramme: From baseline to 9 months.
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Change in general quality of life:
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From baseline to 9 months.
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Symptom checklist (SCL)
Tidsramme: From baseline to 12 weeks.
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Change in AF related symptoms:
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From baseline to 12 weeks.
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Symptom checklist (SCL)
Tidsramme: From baseline to 9 months.
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Change in AF related symptoms:
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From baseline to 9 months.
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Atrial Fibrillation Severity Scale
Tidsramme: From baseline to 12 weeks.
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Change in symptomatic burden
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From baseline to 12 weeks.
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Atrial Fibrillation Severity Scale
Tidsramme: From baseline to 9 months.
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Change in symptomatic burden
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From baseline to 9 months.
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Cardiac Anxiety Questionnaire
Tidsramme: From baseline to 12 weeks.
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Change in symptom preoccupation:
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From baseline to 12 weeks.
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Cardiac Anxiety Questionnaire
Tidsramme: From baseline to 9 months.
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Change in symptom preoccupation
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From baseline to 9 months.
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GAD-7
Tidsramme: From baseline to 12 weeks.
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Change in anxiety
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From baseline to 12 weeks.
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GAD-7
Tidsramme: From baseline to 9 months.
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Change in anxiety
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From baseline to 9 months.
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PHQ-9
Tidsramme: From baseline to 12 weeks.
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Change in depression:
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From baseline to 12 weeks.
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PHQ-9
Tidsramme: From baseline to 9 months.
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Change in depression
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From baseline to 9 months.
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Perceived stress scale
Tidsramme: From baseline to 12 weeks.
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Change in stress reactivity
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From baseline to 12 weeks.
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Perceived stress scale
Tidsramme: From baseline to 9 months.
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Change in stress reactivity
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From baseline to 9 months.
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Change in healthcare consumption and work loss: TIC-P
Tidsramme: From baseline to 12 weeks.
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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).
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From baseline to 12 weeks.
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Change in healthcare consumption and work loss: TIC-P
Tidsramme: From baseline to 9 months.
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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).
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From baseline to 9 months.
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Change in symtomatic burden: Holter ECG.
Tidsramme: From baseline to 12 weeks.
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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")
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From baseline to 12 weeks.
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Change in symptomatic burden: Holter ECG.
Tidsramme: From baseline to 9 months.
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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")
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From baseline to 9 months.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Frieder Braunschweig, PhD, Karolinska Institutet
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2015
Primær fullføring (Faktiske)
30. august 2018
Studiet fullført (Faktiske)
30. august 2018
Datoer for studieregistrering
Først innsendt
14. desember 2015
Først innsendt som oppfylte QC-kriteriene
23. februar 2016
Først lagt ut (Anslag)
29. februar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AF pilot ICBT 2015
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