Clinical trial NCT02694276: Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
Official title: Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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) \[31\]; 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. -

Primary outcomes:
measure: Change in The Atrial Fibrillation Quality of Life (AFEQT)
timeFrame: From baseline to 12 weeks
measure: Change in The Atrial Fibrillation Quality of Life (AFEQT)
timeFrame: From baseline to 9 months.
Secondary outcomes:
measure: WHODAS 2.0 (12-item version) •
timeFrame: From baseline to 12 weeks.
measure: WHODAS 2.0 (12-item version) •
timeFrame: From baseline to 9 months.
measure: Symptom checklist (SCL)
timeFrame: From baseline to 12 weeks.
measure: Symptom checklist (SCL)
timeFrame: From baseline to 9 months.
measure: Atrial Fibrillation Severity Scale
timeFrame: From baseline to 12 weeks.
measure: Atrial Fibrillation Severity Scale
timeFrame: From baseline to 9 months.
measure: Cardiac Anxiety Questionnaire
timeFrame: From baseline to 12 weeks.
measure: Cardiac Anxiety Questionnaire
timeFrame: From baseline to 9 months.
measure: GAD-7
timeFrame: From baseline to 12 weeks.
measure: GAD-7
timeFrame: From baseline to 9 months.
measure: PHQ-9
timeFrame: From baseline to 12 weeks.
measure: PHQ-9
timeFrame: From baseline to 9 months.
measure: Perceived stress scale
timeFrame: From baseline to 12 weeks.
measure: Perceived stress scale
timeFrame: From baseline to 9 months.
measure: Change in healthcare consumption and work loss: TIC-P
timeFrame: From baseline to 12 weeks.
measure: Change in healthcare consumption and work loss: TIC-P
timeFrame: From baseline to 9 months.
measure: Change in symtomatic burden: Holter ECG.
timeFrame: From baseline to 12 weeks.
measure: Change in symptomatic burden: Holter ECG.
timeFrame: From baseline to 9 months.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Clinical Neuroscience, Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Brjánn Ljótsson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Frieder Braunschweig, PhD
role: STUDY_DIRECTOR
References:
citation: Sarnholm J, Skuladottir H, Ruck C, Klaveback S, Olafsdottir E, Pedersen SS, Braunschweig F, Ljotsson B. Internet-Delivered Exposure-Based Therapy for Symptom Preoccupation in Atrial Fibrillation: Uncontrolled Pilot Trial. JMIR Cardio. 2021 Mar 2;5(1):e24524. doi: 10.2196/24524.