CBT for Premature Ventricular Contractions

Karolinska Institutet19 enrolled

Overview

The purpose of the present interdisciplinary research program is to develop and evaluate a disease-specific cognitive behavior therapy (CBT) protocol to increase quality of life (QoL) and reduce symptom burden in patients with Premature Ventricular Contractions (PVC).

Patients will be recruited in collaboration with arrythmia specialist units in Stockholm and through advertisement in local newspapers and social media. All patients giving informed consent will be screened thoroughly by the research nurse and a psychologist before included by the study cardiologist. 20-30 patients that meet eligibility criteria will be included and receive 8-10 sessions of cognitive behavior therapy during 8-10 weeks. Due to the current Covid-19 pandemic, treatment will be delivered face-to face through a secure digital platform. The psychologist delivering the treatment will have direct access to the study cardiologist during treatment. Follow-up at 3 and 6 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ventricular Premature Complexes

Interventions

CBTBEHAVIORAL

Cognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion * 18-70 years old * PVCs that cause moderate to severe symptoms and leads to significant distress or interferes with daily life. * Optimal medical treatment in the opinion of the treating physician. * Able to read and write in Swedish. Exclusion * Structural heart disease including previous myocardial infarction, heart failure with preserved or reduced left ventricular ejection fraction, valvular disease, previous cardiac surgery. * Other arrhythmia or severe medical illness; * Scheduled for ablation therapy or any other cardiovascular intervention * Any medical restriction to physical exercise. * Severe depression or risk of suicide; * Alcohol dependency. All patients will undergo thorough cardiological and psychological assessment to ensure that eligibility criteria are met.

Locations (1)

Karolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

Version of the Atrial Fibrillation effects on Quality-of-life (AFEQT), adjusted to Premature Ventricular Contractions. Measures PVC-specific Quality of life in several domains. 14 questions graded on a 7 points likert scale. The total score ranges between 0 (severe symptoms and disability) and 98 (no symptoms and disability)

Time frame: baseline

Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

Time frame: 10 weeks from baseline

Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

Time frame: 5 months from baseline

Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

Time frame: 8 months from baseline

Secondary Outcomes

12-Item 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.

Data from ClinicalTrials.gov

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Time frame: baseline

12-Item 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.

Time frame: 10 weeks from baseline

12-Item 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.

Time frame: 5 months from baseline

12-Item 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.

Time frame: 8 months from baseline

Symptom Checklist (SCL)

Measures frequency and severity of 16 symptoms often experienced by patients with Atrial Fibrillation. Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms. For total score sub scores are summed

Time frame: baseline

Symptom Checklist (SCL)

Time frame: 10 weeks from baseline

Symptom Checklist (SCL)

Time frame: 5 months from baseline

Symptom Checklist (SCL)

Time frame: 8 months from baseline

Arrhythmia burden

Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring

Time frame: baseline

Arrhythmia burden

Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring

Time frame: 10 weeks from baseline

Arrhythmia burden

Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring

Time frame: 8 months from baseline

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.

Time frame: baseline

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.

Time frame: 10 weeks from baseline

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.

Time frame: 5 months from baseline

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.

Time frame: 8 months from baseline