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

NCT04962932 | Completed

• 1 other identifier: AF RCT 2
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Arrythmia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (30)

• Cardiac Anxiety Questionnaire (CAQ)

  From baseline to 10 weeks

• Cardiac Anxiety Questionnaire (CAQ)

  From baseline to 9 months

• AF-avoidance behavior questionnaire

  From baseline to 10 weeks

• AF-avoidance behavior 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

Other Outcomes (7)

• Psychosocial stressors and changes in physical health

  10 weeks from baseline

• Psychosocial stressors and changes in physical health

  9 months from baseline

• Background data

  Baseline

Study Arms (2)

Internet-delivered exposure-focused CBT

EXPERIMENTAL

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

Internet-delivered stress management treatment

ACTIVE COMPARATOR

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

Interventions

Internet-deliviered exposure-based CBT BEHAVIORAL

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.

Internet-delivered exposure-focused CBT

Internet-delivered stress management treatment BEHAVIORAL

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.

Internet-delivered stress management treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska universitetssjukhuset Solna

Solna, 171 64, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brjann Ljotsson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor,PhD, Lic. psychologist

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 15, 2021
• Study Start: August 13, 2021
• Primary Completion: March 31, 2023
• Study Completion: October 5, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

SE (1)