Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378349
• Other study ID #: AF RCT 1
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: September 20, 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim 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) compared to treatment as usual. The study will include 120 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 more than a wait list offered treatment as usual.

Method: A randomized controlled trial. Participants are randomized to internet-delivered CBT for 10 weeks (N=60) or to treatment as usual (N=60). The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls. Patients on the treatment as usual wait list will be provided standardized written information about basic self-management in AF. The treatment as usual wait list will be crossed over to treatment 3 months after the treatment group has completed treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 20, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion 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) ; B) Age 18-75 years; C) On optimal medical treatment; D). Able to read and write in Swedish.

Exclusion Criteria:

• (E) heart failure with severe systolic dysfunction (ejection fraction = 35%); (F) significant valvular disease; (G) planned ablation for AF or ablation within 3 months before assessment; (H) other severe medical illness; (I) any medical restriction to physical exercise; (J) severe psychiatric disorder, severe depression, or risk of suicide; (K) alcohol dependency.

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation

Intervention

Behavioral:
• Internet-delivered cognitive behavior therapy
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.
• Treatment as usual
Consist of standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health, without the guidance of a psychologist or any CBT interventions.

Locations

Country	Name	City	State
Sweden	Karolinska universitetssjukhuset Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-rated health, 1 item	The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.	From baseline to 12 weeks
Other	Self-rated health, 1 item	The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.	From baseline to 6 months
Other	Self-rated health, 1 item	The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.	From baseline to 15 months
Other	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
Other	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 6 months
Other	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 15 months
Other	The International Physical Activity Questionnaire	Physical activity	From baseline to 6 months
Other	The International Physical Activity Questionnaire	Physical activity	From baseline to 12 weeks
Other	The International Physical Activity Questionnaire	Physical activity	From baseline to 9 months
Other	The International Physical Activity Questionnaire	Physical activity	From baseline to 15 months
Other	Body Sensation Questionnaire	Fear of bodily sensations	From baseline to 12 weeks
Other	Body Sensation Questionnaire	Fear of bodily sensations	From baseline to 6 months
Other	Body Sensation Questionnaire	Fear of bodily sensations	From baseline to 15 months
Other	Anxiety Sensitivity Index	Anxiety sensitivity	From baseline to 12 weeks
Other	Anxiety Sensitivity Index	Anxiety sensitivity	From baseline to 6 months
Other	Anxiety Sensitivity Index	Anxiety sensitivity	From baseline to 15 months
Other	Accelerometer	Objective measurement of physical activity 1 week	From baseline to 12 weeks
Other	Accelerometer	Objective measurement of physical activity 1 week	From baseline to 6 months
Other	Accelerometer	Objective measurement of physical activity 1 week	From baseline to 15 months
Other	Perceived stress scale (4-item version)	Stress reactivity	From baseline to 12 weeks
Other	Perceived stress scale (4-item version)	Stress reactivity	From baseline to 6 months
Other	Perceived stress scale (4-item version)	Stress reactivity	From baseline to 9 months
Other	Perceived stress scale (4-item version)	Stress reactivity	From baseline to 15 months
Primary	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 6 months PRIMARY ENDPOINT
Primary	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	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
Primary	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 15 months
Secondary	Electrocardiography (ECG) measurement	Change in symptomatic burden. The patient will undergo 5 days 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	ECG measurement	Change in symptomatic burden. The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")	From baseline to 6 months
Secondary	ECG measurement	Change in symptomatic burden. The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")	From baseline to 15 months
Secondary	Cardiac Anxiety Questionary (CAQ)	Symptom preoccupation	From baseline to 12 weeks
Secondary	Cardiac Anxiety Questionary (CAQ)	Symptom preoccupation	From baseline to 6 months
Secondary	Cardiac Anxiety Questionary (CAQ)	Symptom preoccupation	From baseline to 9 months
Secondary	Cardiac Anxiety Questionary (CAQ)	Symptom preoccupation	From baseline to 15 months
Secondary	the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)	General quality of life	From baseline to 12 weeks
Secondary	WHODAS 2.0 (12-item version)	General quality of life	From baseline to 6 months
Secondary	WHODAS 2.0 (12-item version)	General quality of life	From baseline to 15 months
Secondary	Symptom checklist Severity and Frequency Scale (SCL)	AF related symptoms	From baseline to 12 weeks
Secondary	Symptom checklist Severity and Frequency Scale (SCL)	AF related symptoms	From baseline to 6 months
Secondary	Symptom checklist Severity and Frequency Scale (SCL)	AF related symptoms	From baseline to 15 months
Secondary	Atrial Fibrillation Severity Scale	Symptomatic burden	From baseline to 12 weeks
Secondary	Atrial Fibrillation Severity Scale	Symptomatic burden	From baseline to 6 months
Secondary	Atrial Fibrillation Severity Scale	Symptomatic burden	From baseline to 15 months
Secondary	Patient Health Questionnaire (PHQ-9)	Depression	From baseline to 12 weeks
Secondary	PHQ-9	Depression	From baseline to 6 months
Secondary	PHQ-9	Depression	From baseline to 15 months
Secondary	Client satisfaction Questionnaire	Treatment satisfaction	From baseline to 12 weeks
Secondary	Adverse events	Potential adverse reactions to the treatment	From baseline to 12 weeks