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

NCT04962932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2023-10-11

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Brjann Ljotsson, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-13
Primary Completion
2023-03-31
Completion
2023-10-05

Countries

  • Sweden

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04962932 on ClinicalTrials.gov