Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive behavior therapy
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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. -
Sites / Locations
- Department of Clinical Neuroscience, Karolinska Institutet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Internet-based cognitive behavior therapy
Arm Description
10 sessions of ICBT during 10 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
WHODAS 2.0 (12-item version) •
Change in general quality of life
WHODAS 2.0 (12-item version) •
Change in general quality of life:
Symptom checklist (SCL)
Change in AF related symptoms:
Symptom checklist (SCL)
Change in AF related symptoms:
Atrial Fibrillation Severity Scale
Change in symptomatic burden
Atrial Fibrillation Severity Scale
Change in symptomatic burden
Cardiac Anxiety Questionnaire
Change in symptom preoccupation:
Cardiac Anxiety Questionnaire
Change in symptom preoccupation
GAD-7
Change in anxiety
GAD-7
Change in anxiety
PHQ-9
Change in depression:
PHQ-9
Change in depression
Perceived stress scale
Change in stress reactivity
Perceived stress scale
Change in stress reactivity
Change in healthcare consumption and work loss: TIC-P
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Change in healthcare consumption and work loss: TIC-P
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Change in symtomatic burden: Holter ECG.
The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Change in symptomatic burden: Holter ECG.
The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Full Information
NCT ID
NCT02694276
First Posted
December 14, 2015
Last Updated
August 19, 2019
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02694276
Brief Title
Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
Official Title
Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Arrhythmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based cognitive behavior therapy
Arm Type
Experimental
Arm Description
10 sessions of ICBT during 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive behavior therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in The Atrial Fibrillation Quality of Life (AFEQT)
Description
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Time Frame
From baseline to 12 weeks
Title
Change in The Atrial Fibrillation Quality of Life (AFEQT)
Description
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Time Frame
From baseline to 9 months.
Secondary Outcome Measure Information:
Title
WHODAS 2.0 (12-item version) •
Description
Change in general quality of life
Time Frame
From baseline to 12 weeks.
Title
WHODAS 2.0 (12-item version) •
Description
Change in general quality of life:
Time Frame
From baseline to 9 months.
Title
Symptom checklist (SCL)
Description
Change in AF related symptoms:
Time Frame
From baseline to 12 weeks.
Title
Symptom checklist (SCL)
Description
Change in AF related symptoms:
Time Frame
From baseline to 9 months.
Title
Atrial Fibrillation Severity Scale
Description
Change in symptomatic burden
Time Frame
From baseline to 12 weeks.
Title
Atrial Fibrillation Severity Scale
Description
Change in symptomatic burden
Time Frame
From baseline to 9 months.
Title
Cardiac Anxiety Questionnaire
Description
Change in symptom preoccupation:
Time Frame
From baseline to 12 weeks.
Title
Cardiac Anxiety Questionnaire
Description
Change in symptom preoccupation
Time Frame
From baseline to 9 months.
Title
GAD-7
Description
Change in anxiety
Time Frame
From baseline to 12 weeks.
Title
GAD-7
Description
Change in anxiety
Time Frame
From baseline to 9 months.
Title
PHQ-9
Description
Change in depression:
Time Frame
From baseline to 12 weeks.
Title
PHQ-9
Description
Change in depression
Time Frame
From baseline to 9 months.
Title
Perceived stress scale
Description
Change in stress reactivity
Time Frame
From baseline to 12 weeks.
Title
Perceived stress scale
Description
Change in stress reactivity
Time Frame
From baseline to 9 months.
Title
Change in healthcare consumption and work loss: TIC-P
Description
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Time Frame
From baseline to 12 weeks.
Title
Change in healthcare consumption and work loss: TIC-P
Description
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Time Frame
From baseline to 9 months.
Title
Change in symtomatic burden: Holter ECG.
Description
The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Time Frame
From baseline to 12 weeks.
Title
Change in symptomatic burden: Holter ECG.
Description
The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Time Frame
From baseline to 9 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brjánn Ljótsson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frieder Braunschweig, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Department of Clinical Neuroscience, Karolinska Institutet
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
33650972
Citation
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.
Results Reference
derived
Learn more about this trial
Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
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