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

Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation- a Randomized Controlled Trial With Active Control

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrythmia
• Intervention / Treatment: Behavioral: Internet-deliviered exposure-based CBT; Behavioral: Internet-delivered stress management treatment

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 Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Solna, Sweden, 171 64
    • Karolinska Universitetssjukhuset Solna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-delivered exposure-focused 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.	Behavioral: Internet-deliviered exposure-based CBT; The intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention. Include the guidance of a minimum weekly contact with a CBT psychologist.
Active Comparator: 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.	Behavioral: Internet-delivered stress management treatment; The intervention last for 10 weeks and include: Internet-SMT include life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Patients are offered regular online contact with a psychologist with the same frequency and intensity as in the CBT arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment	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).	Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT]
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment	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).	From baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	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').	10 weeks from baseline
Cardiac Anxiety Questionnaire (CAQ)	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	From baseline to 10 weeks
Cardiac Anxiety Questionnaire (CAQ)	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	From baseline to 9 months
AF-avoidance behavior questionnaire	Form measuring AF-specific avoidance- and control behaviors, developed by the research group	From baseline to 10 weeks
AF-avoidance behavior questionnaire	Form measuring AF-specific avoidance- and control behaviors, developed by the research group	From baseline to 9 months
AF-avoidance behavior questionnaire modified for weekly assessment	4 items from the AF-avoidance behavior questionnaire	Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment
Short Form Health Survey (SF-12)	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	From baseline to 10 weeks
Short Form Health Survey (SF-12)	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	From baseline to 9 months
Atrial Fibrillation Severity Scale (4 items)	4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking	From baseline to 10 weeks
Atrial Fibrillation Severity Scale (4 items)	4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking	From baseline to 9 months
The Godin-Shepard Leisure-Time Physical Activity Questionnaire	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.	From baseline to 10 weeks
The Godin-Shepard Leisure-Time Physical Activity Questionnaire	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.	From baseline to 9 months
Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	From baseline to 10 weeks
Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	From baseline to 9 months
Patient Health Questionnaire-2	Short form measuring depression, score ranging 0 to 6 with a higher score indicating higher level of depression.	From baseline to 10 weeks
Patient Health Questionnaire-2	Short form measuring depression, score ranging 0 to 6 ,with a higher score indicating higher level of depression.	From baseline to 9 months
Perceived Stress Scale (4 items version)	Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress	From baseline to 10 weeks
Perceived Stress Scale (4 items version)	Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress	From baseline to 9 months
Generalized Anxiety Disorder-2 (GAD-2)	General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.	From baseline to 10 weeks
Generalized Anxiety Disorder-2	General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.	From baseline to 9 months
Insomnia Severity Index (5 items)	Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia	From baseline to 10 weeks
Insomnia Severity Index (5 items)	Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia	From Baseline to 9 months
Perceived Competence Scale	Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence	From baseline to 10 weeks
Perceived Competence Scale	Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence	From baseline to 9 months
Client Satisfaction Questionnaire	Treatment satisfaction, score ranging from 0-24, with a higher score indicating higher satisfaction with treatment.	10 weeks from baseline
Adverse events	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').	9 months from baseline
Symptoms Checklist Severity and Frequency Scale (SCL)	AF-related symptoms	From baseline to 10 weeks
Symptoms Checklist Severity and Frequency Scale (SCL)	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	From baseline to 9 months
AFFS/SCL-4	4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT	Weekly from baseline to 10 weeks
AFFS/SCL-4	4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT	From baseline to 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial stressors and changes in physical health	Participants are asked about their self-perceived health and if they have experienced any stressful event that they believe have affected their health (e.g severe disease, death of close relative, divorce)	10 weeks from baseline
Psychosocial stressors and changes in physical health	Participants are asked about their self-perceived health and if they have experienced any stressful event that they believe have affected their health (e.g severe disease, death of close relative, divorce)	9 months from baseline
Background data	Demographics, list of medications, co-morbidity, smoking history and alcohol consumption	Baseline
Treatment Credibility Scale	Measures treatment credibility	2-4 weeks from baseline
Working Alliance Inventory	Measures therapeutic alliance with the psychologist	2-4 weeks from baseline
Changes in medication	Participants are asked if they have made any changes in medication	10 weeks from baseline
Changes in medication	Participants are asked if they have made any changes in medication	9 months from baseline

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Brjann Ljotsson, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2021
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF RCT 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No