Internet-based Cognitive Behavior Therapy for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Internet-based Cognitive Behavior Therapy for Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694276
• Other study ID #: AF pilot ICBT 2015
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: August 30, 2018

Study information

• Verified date: August 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation

Intervention

Behavioral:
• Internet-based cognitive behavior therapy
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.

Locations

Country	Name	City	State
Sweden	Department of Clinical Neuroscience, Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	WHODAS 2.0 (12-item version) •	Change in general quality of life	From baseline to 12 weeks.
Secondary	WHODAS 2.0 (12-item version) •	Change in general quality of life:	From baseline to 9 months.
Secondary	Symptom checklist (SCL)	Change in AF related symptoms:	From baseline to 12 weeks.
Secondary	Symptom checklist (SCL)	Change in AF related symptoms:	From baseline to 9 months.
Secondary	Atrial Fibrillation Severity Scale	Change in symptomatic burden	From baseline to 12 weeks.
Secondary	Atrial Fibrillation Severity Scale	Change in symptomatic burden	From baseline to 9 months.
Secondary	Cardiac Anxiety Questionnaire	Change in symptom preoccupation:	From baseline to 12 weeks.
Secondary	Cardiac Anxiety Questionnaire	Change in symptom preoccupation	From baseline to 9 months.
Secondary	GAD-7	Change in anxiety	From baseline to 12 weeks.
Secondary	GAD-7	Change in anxiety	From baseline to 9 months.
Secondary	PHQ-9	Change in depression:	From baseline to 12 weeks.
Secondary	PHQ-9	Change in depression	From baseline to 9 months.
Secondary	Perceived stress scale	Change in stress reactivity	From baseline to 12 weeks.
Secondary	Perceived stress scale	Change in stress reactivity	From baseline to 9 months.
Secondary	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).	From baseline to 12 weeks.
Secondary	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).	From baseline to 9 months.
Secondary	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")	From baseline to 12 weeks.
Secondary	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")	From baseline to 9 months.