Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arrythmia
• Interventions: Behavioral: Internet-deliviered exposure-based CBT; Behavioral: Internet-delivered stress management treatment

• Registration Number: NCT04962932
• Lead Sponsor: Karolinska Institutet

Brief Summary

The aim of this study 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), controlling for expectancy of improvement and attention from a caregiver, using an active control group (stress management). The study will include 260 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 controlling for expectancy of improvement and attention from a caregiver using an active control group receiving stress management treatment (SMT).

Method: A randomized controlled trial. Participants are randomized to internet- delivered exposure-based CBT (N=130) or to SMT (N=130). Participants in both groups receive weekly therapist support through online written communication. The internet-delivered SMT-treatment includes life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Both treatments lasts 10 weeks and are comparable regarding number of treatment modules, treatment burden and attention from the treating psychologist.

Study Timeline

• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-15
• Study Start: 2021-08-13
• Primary Completion: 2023-03-31
• Status Verified: 2023-10
• Study Completion: 2023-10-05
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• 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);
• Scoring ≥ 20 on the Cardiac Anxiety Questionnaire at screening;
• Age 18-75 years;
• On optimal medical treatment;
• Able to read and write in Swedish.

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Exclusion Criteria

• Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%);
• Significant valvular disease;
• Planned ablation for AF or ablation within 3 months before assessment;
• Other severe medical illness;
• Any medical restriction to physical exercise;
• Severe psychiatric disorder, severe depression, or risk of suicide;
• Alcohol dependency;
• Previous participation in any AF-CBT study conducted by the research group.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-delivered exposure-focused CBT	Internet-deliviered exposure-based CBT	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.
Internet-delivered stress management treatment	Internet-delivered stress management treatment	Stress management treatment for 10 weeks Participants randomized to The Stress Management Treatment will receive 10 weeks of stress managemen including relaxation technics, standard life style advice regarding physical activity, sleep and and standardized AF-information in line with current guidelines for AF. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists.

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment	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. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability).

Secondary Outcome Measures

Name	Time	Method
Short Form Health Survey (SF-12)	From baseline to 9 months	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
The Godin-Shepard Leisure-Time Physical Activity Questionnaire	From baseline to 9 months	Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.
AF-avoidance behavior questionnaire modified for weekly assessment	Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment	4 items from the AF-avoidance behavior questionnaire
Generalized Anxiety Disorder-2 (GAD-2)	From baseline to 10 weeks	General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.
Insomnia Severity Index (5 items)	From Baseline to 9 months	Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia
Cardiac Anxiety Questionnaire (CAQ)	From baseline to 9 months	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
AF-avoidance behavior questionnaire	From baseline to 9 months	Form measuring AF-specific avoidance- and control behaviors, developed by the research group
Body Sensation Questionnaire	From baseline to 9 months	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Adverse events	9 months from baseline	Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').
Perceived Stress Scale (4 items version)	From baseline to 9 months	Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress
Generalized Anxiety Disorder-2	From baseline to 9 months	General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.
Symptoms Checklist Severity and Frequency Scale (SCL)	From baseline to 9 months	AF-related symptoms measured in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
AFFS/SCL-4	From baseline to 9 months	4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT
Atrial Fibrillation Severity Scale (4 items)	From baseline to 9 months	4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking
Patient Health Questionnaire-2	From baseline to 9 months	Short form measuring depression, score ranging 0 to 6 ,with a higher score indicating higher level of depression.
Perceived Competence Scale	From baseline to 9 months	Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence
Client Satisfaction Questionnaire	10 weeks from baseline	Treatment satisfaction, score ranging from 0-24, with a higher score indicating higher satisfaction with treatment.

Trial Locations

Locations (1)

Karolinska universitetssjukhuset Solna; 🇸🇪 Solna, Sweden