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

Atrial Fibrillation Clinical Trial

Official title:

Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation- a Randomized Controlled Trial With Active Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04962932
• Other study ID #: AF RCT 2
• Status: Completed
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: October 5, 2023

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 controlling for expectancy of improvement and attention from a caregiver using an active control group receiving stress management treatment (SMT).

Method: A randomized controlled trial. Participants are randomized to internet- delivered exposure-based CBT (N=130) or to SMT (N=130). Participants in both groups receive weekly therapist support through online written communication. The internet-delivered SMT-treatment includes life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Both treatments lasts 10 weeks and are comparable regarding number of treatment modules, treatment burden and attention from the treating psychologist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: October 5, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arrythmia
• Atrial Fibrillation

Intervention

Behavioral:
• Internet-deliviered exposure-based CBT
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 stress management treatment
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.

Locations

Country	Name	City	State
Sweden	Karolinska universitetssjukhuset Solna	Solna

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychosocial stressors and changes in physical health	Participants are asked about their self-perceived health and if they have experienced any stressful event that they believe have affected their health (e.g severe disease, death of close relative, divorce)	10 weeks from baseline
Other	Psychosocial stressors and changes in physical health	Participants are asked about their self-perceived health and if they have experienced any stressful event that they believe have affected their health (e.g severe disease, death of close relative, divorce)	9 months from baseline
Other	Background data	Demographics, list of medications, co-morbidity, smoking history and alcohol consumption	Baseline
Other	Treatment Credibility Scale	Measures treatment credibility	2-4 weeks from baseline
Other	Working Alliance Inventory	Measures therapeutic alliance with the psychologist	2-4 weeks from baseline
Other	Changes in medication	Participants are asked if they have made any changes in medication	10 weeks from baseline
Other	Changes in medication	Participants are asked if they have made any changes in medication	9 months from baseline
Primary	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]
Primary	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	Cardiac Anxiety Questionnaire (CAQ)	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	From baseline to 10 weeks
Secondary	Cardiac Anxiety Questionnaire (CAQ)	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	From baseline to 9 months
Secondary	AF-avoidance behavior questionnaire	Form measuring AF-specific avoidance- and control behaviors, developed by the research group	From baseline to 10 weeks
Secondary	AF-avoidance behavior questionnaire	Form measuring AF-specific avoidance- and control behaviors, developed by the research group	From baseline to 9 months
Secondary	AF-avoidance behavior questionnaire modified for weekly assessment	4 items from the AF-avoidance behavior questionnaire	Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment
Secondary	Short Form Health Survey (SF-12)	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	From baseline to 10 weeks
Secondary	Short Form Health Survey (SF-12)	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	From baseline to 9 months
Secondary	Atrial Fibrillation Severity Scale (4 items)	4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking	From baseline to 10 weeks
Secondary	Atrial Fibrillation Severity Scale (4 items)	4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking	From baseline to 9 months
Secondary	The Godin-Shepard Leisure-Time Physical Activity Questionnaire	Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.	From baseline to 10 weeks
Secondary	The Godin-Shepard Leisure-Time Physical Activity Questionnaire	Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.	From baseline to 9 months
Secondary	Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	From baseline to 10 weeks
Secondary	Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	From baseline to 9 months
Secondary	Patient Health Questionnaire-2	Short form measuring depression, score ranging 0 to 6 with a higher score indicating higher level of depression.	From baseline to 10 weeks
Secondary	Patient Health Questionnaire-2	Short form measuring depression, score ranging 0 to 6 ,with a higher score indicating higher level of depression.	From baseline to 9 months
Secondary	Perceived Stress Scale (4 items version)	Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress	From baseline to 10 weeks
Secondary	Perceived Stress Scale (4 items version)	Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress	From baseline to 9 months
Secondary	Generalized Anxiety Disorder-2 (GAD-2)	General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.	From baseline to 10 weeks
Secondary	Generalized Anxiety Disorder-2	General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.	From baseline to 9 months
Secondary	Insomnia Severity Index (5 items)	Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia	From baseline to 10 weeks
Secondary	Insomnia Severity Index (5 items)	Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia	From Baseline to 9 months
Secondary	Perceived Competence Scale	Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence	From baseline to 10 weeks
Secondary	Perceived Competence Scale	Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence	From baseline to 9 months
Secondary	Client Satisfaction Questionnaire	Treatment satisfaction, score ranging from 0-24, with a higher score indicating higher satisfaction with treatment.	10 weeks from baseline
Secondary	Adverse events	Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').	10 weeks from baseline
Secondary	Adverse events	Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').	9 months from baseline
Secondary	Symptoms Checklist Severity and Frequency Scale (SCL)	AF-related symptoms	From baseline to 10 weeks
Secondary	Symptoms Checklist Severity and Frequency Scale (SCL)	AF-related symptoms measured in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms	From baseline to 9 months
Secondary	AFFS/SCL-4	4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT	Weekly from baseline to 10 weeks
Secondary	AFFS/SCL-4	4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT	From baseline to 9 months