Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
19 augusti 2019 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
19
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Stockholm, Sverige
- Department of Clinical Neuroscience, Karolinska Institutet
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in The Atrial Fibrillation Quality of Life (AFEQT)
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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WHODAS 2.0 (12-item version) •
Tidsram: 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) •
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Frieder Braunschweig, PhD, Karolinska Institutet
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2015
Primärt slutförande (Faktisk)
30 augusti 2018
Avslutad studie (Faktisk)
30 augusti 2018
Studieregistreringsdatum
Först inskickad
14 december 2015
Först inskickad som uppfyllde QC-kriterierna
23 februari 2016
Första postat (Uppskatta)
29 februari 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 augusti 2019
Senast verifierad
1 augusti 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AF pilot ICBT 2015
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