NCT02694276

Brief Summary

The aim is to evaluate if internet- delivered CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will include 30 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

December 14, 2015

Last Update Submit

August 19, 2019

Conditions

Atrial FibrillationArrhythmia

Outcome Measures

Primary Outcomes (2)

  • Change in The Atrial Fibrillation Quality of Life (AFEQT)

    The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.

    From baseline to 12 weeks

  • Change in The Atrial Fibrillation Quality of Life (AFEQT)

    The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.

    From baseline to 9 months.

Secondary Outcomes (18)

  • WHODAS 2.0 (12-item version) •

    From baseline to 12 weeks.

  • WHODAS 2.0 (12-item version) •

    From baseline to 9 months.

  • Symptom checklist (SCL)

    From baseline to 12 weeks.

  • Symptom checklist (SCL)

    From baseline to 9 months.

  • Atrial Fibrillation Severity Scale

    From baseline to 12 weeks.

  • +13 more secondary outcomes

Study Arms (1)

Internet-based cognitive behavior therapy

EXPERIMENTAL

10 sessions of ICBT during 10 weeks.

Behavioral: Internet-based cognitive behavior therapy

Interventions

Internet-based cognitive behavior therapyBEHAVIORAL

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 fruitlessly aim to prevent triggering of AF episodes or 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.

Internet-based cognitive behavior therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A) 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) \[31\]; B) Age 18-75 years; C) Able to read and write in Swedish.

You may not qualify if:

  • C) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); D) Significant valvular disease; E) Other severe medical illness; F) Severe depression or risk of suicide; G) Alcohol dependency. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Neuroscience, Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

  • Sarnholm J, Skuladottir H, Ruck C, Klaveback S, Olafsdottir E, Pedersen SS, Braunschweig F, Ljotsson B. Internet-Delivered Exposure-Based Therapy for Symptom Preoccupation in Atrial Fibrillation: Uncontrolled Pilot Trial. JMIR Cardio. 2021 Mar 2;5(1):e24524. doi: 10.2196/24524.

    PMID: 33650972DERIVED

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brjánn Ljótsson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Frieder Braunschweig, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, lic. psychologist

Study Record Dates

First Submitted

December 14, 2015

First Posted

February 29, 2016

Study Start

December 1, 2015

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

SE(1)