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Clinical Trials/NCT05087238
NCT05087238
Completed
Not Applicable

Cognitive Behavior Therapy for Patients With Premature Ventricular Contractions - a Pilot Study

Karolinska Institutet1 site in 1 country19 target enrollmentJanuary 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Premature Complexes
Sponsor
Karolinska Institutet
Enrollment
19
Locations
1
Primary Endpoint
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 14, 2021
End Date
May 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Frieder Braunschweig

Professor

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Arrhythmia burden(8 months from baseline)
  • Cardiac anxiety questionnaire (CAQ)(8 months from baseline)
  • 12-Item Short-Form Health Survey (SF-12)(8 months from baseline)
  • Symptom Checklist (SCL)(8 months from baseline)

Study Sites (1)

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