CBT for Premature Ventricular Contractions

Not Applicable

Completed

• Conditions: Ventricular Premature Complexes
• Interventions: Behavioral: CBT

• Registration Number: NCT05087238
• Lead Sponsor: Karolinska Institutet

Brief Summary

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).

Detailed Description

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 Timeline

• Study Start: 2021-01-14
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-21
• Primary Completion: 2021-11-05
• Study Completion: 2022-05-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PVC-specific CBT	CBT	This novel CBT treatment for symptomatic PVC targets cardiac anxiety and symptom preoccupation related to PVC. Treatment is developed from the research groups treatment for Atrial Fibrillation and may be altered during the treatment period to better meet the needs of the patients. Patients receive 10 weeks of CBT delivered through face to face digital video sessions.

Primary Outcome Measures

Name	Time	Method
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)	8 months from baseline	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)

Secondary Outcome Measures

Name	Time	Method
Arrhythmia burden	8 months from baseline	Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
Cardiac anxiety questionnaire (CAQ)	8 months from baseline	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
12-Item Short-Form Health Survey (SF-12)	8 months from baseline	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Symptom Checklist (SCL)	8 months from baseline	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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden