Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation- a Randomized Controlled Trial With Active Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Internet-deliviered exposure-based CBT (Behavioral)
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.
Intervention: Internet-delivered stress management treatment (Behavioral)
Outcomes
Primary Outcomes
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment
Time Frame: 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).
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment
Time Frame: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT]
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 Outcomes
- Short Form Health Survey (SF-12)(From baseline to 9 months)
- The Godin-Shepard Leisure-Time Physical Activity Questionnaire(From baseline to 9 months)
- AF-avoidance behavior questionnaire modified for weekly assessment(Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment)
- Generalized Anxiety Disorder-2 (GAD-2)(From baseline to 10 weeks)
- Insomnia Severity Index (5 items)(From Baseline to 9 months)
- Cardiac Anxiety Questionnaire (CAQ)(From baseline to 9 months)
- AF-avoidance behavior questionnaire(From baseline to 9 months)
- Body Sensation Questionnaire(From baseline to 9 months)
- Adverse events(9 months from baseline)
- Perceived Stress Scale (4 items version)(From baseline to 9 months)
- Generalized Anxiety Disorder-2(From baseline to 9 months)
- Symptoms Checklist Severity and Frequency Scale (SCL)(From baseline to 9 months)
- AFFS/SCL-4(From baseline to 9 months)
- Atrial Fibrillation Severity Scale (4 items)(From baseline to 9 months)
- Patient Health Questionnaire-2(From baseline to 9 months)
- Perceived Competence Scale(From baseline to 9 months)
- Client Satisfaction Questionnaire(10 weeks from baseline)
- Perceived Competence Scale(From baseline to 10 weeks)
- Cardiac Anxiety Questionnaire (CAQ)(From baseline to 10 weeks)
- AF-avoidance behavior questionnaire(From baseline to 10 weeks)
- Short Form Health Survey (SF-12)(From baseline to 10 weeks)
- Atrial Fibrillation Severity Scale (4 items)(From baseline to 10 weeks)
- The Godin-Shepard Leisure-Time Physical Activity Questionnaire(From baseline to 10 weeks)
- Body Sensation Questionnaire(From baseline to 10 weeks)
- Patient Health Questionnaire-2(From baseline to 10 weeks)
- Perceived Stress Scale (4 items version)(From baseline to 10 weeks)
- Insomnia Severity Index (5 items)(From baseline to 10 weeks)
- Adverse events(10 weeks from baseline)
- Symptoms Checklist Severity and Frequency Scale (SCL)(From baseline to 10 weeks)
- AFFS/SCL-4(Weekly from baseline to 10 weeks)
Investigators
Brjann Ljotsson
Associate professor,PhD, Lic. psychologist
Karolinska Institutet