Clinical trial NCT04962932: Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation
Official title: Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation- a Randomized Controlled Trial With Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Arrythmia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2021-07-15
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment
timeFrame: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT]
measure: Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment
timeFrame: From baseline to 9 months
Secondary outcomes:
measure: Cardiac Anxiety Questionnaire (CAQ)
timeFrame: From baseline to 10 weeks
measure: Cardiac Anxiety Questionnaire (CAQ)
timeFrame: From baseline to 9 months
measure: AF-avoidance behavior questionnaire
timeFrame: From baseline to 10 weeks
measure: AF-avoidance behavior questionnaire
timeFrame: From baseline to 9 months
measure: AF-avoidance behavior questionnaire modified for weekly assessment
timeFrame: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment
measure: Short Form Health Survey (SF-12)
timeFrame: From baseline to 10 weeks
measure: Short Form Health Survey (SF-12)
timeFrame: From baseline to 9 months
measure: Atrial Fibrillation Severity Scale (4 items)
timeFrame: From baseline to 10 weeks
measure: Atrial Fibrillation Severity Scale (4 items)
timeFrame: From baseline to 9 months
measure: The Godin-Shepard Leisure-Time Physical Activity Questionnaire
timeFrame: From baseline to 10 weeks
measure: The Godin-Shepard Leisure-Time Physical Activity Questionnaire
timeFrame: From baseline to 9 months
measure: Body Sensation Questionnaire
timeFrame: From baseline to 10 weeks
measure: Body Sensation Questionnaire
timeFrame: From baseline to 9 months
measure: Patient Health Questionnaire-2
timeFrame: From baseline to 10 weeks
measure: Patient Health Questionnaire-2
timeFrame: From baseline to 9 months
measure: Perceived Stress Scale (4 items version)
timeFrame: From baseline to 10 weeks
measure: Perceived Stress Scale (4 items version)
timeFrame: From baseline to 9 months
measure: Generalized Anxiety Disorder-2 (GAD-2)
timeFrame: From baseline to 10 weeks
measure: Generalized Anxiety Disorder-2
timeFrame: From baseline to 9 months
measure: Insomnia Severity Index (5 items)
timeFrame: From baseline to 10 weeks
measure: Insomnia Severity Index (5 items)
timeFrame: From Baseline to 9 months
measure: Perceived Competence Scale
timeFrame: From baseline to 10 weeks
measure: Perceived Competence Scale
timeFrame: From baseline to 9 months
measure: Client Satisfaction Questionnaire
timeFrame: 10 weeks from baseline
measure: Adverse events
timeFrame: 10 weeks from baseline
measure: Adverse events
timeFrame: 9 months from baseline
measure: Symptoms Checklist Severity and Frequency Scale (SCL)
timeFrame: From baseline to 10 weeks
measure: Symptoms Checklist Severity and Frequency Scale (SCL)
timeFrame: From baseline to 9 months
measure: AFFS/SCL-4
timeFrame: Weekly from baseline to 10 weeks
measure: AFFS/SCL-4
timeFrame: From baseline to 9 months
Other outcomes:
measure: Psychosocial stressors and changes in physical health
timeFrame: 10 weeks from baseline
measure: Psychosocial stressors and changes in physical health
timeFrame: 9 months from baseline
measure: Background data
timeFrame: Baseline
measure: Treatment Credibility Scale
timeFrame: 2-4 weeks from baseline
measure: Working Alliance Inventory
timeFrame: 2-4 weeks from baseline
measure: Changes in medication
timeFrame: 10 weeks from baseline
measure: Changes in medication
timeFrame: 9 months from baseline
Locations:
city: Solna
country: Sweden
facility: Karolinska universitetssjukhuset Solna
Study officials:
affiliation: Karolinska Institutet
name: Brjann Ljotsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: