CBT for Premature Ventricular Contractions

NCT05087238 | Completed

• 1 other identifier: PVC-CBT
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Ventricular Premature Complexes

Outcome Measures

Primary Outcomes (4)

• 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)

  baseline

• 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)

  10 weeks from baseline

• 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)

  5 months from baseline

• 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)

  8 months from baseline

Secondary Outcomes (15)

• 12-Item Short-Form Health Survey (SF-12)

  baseline

• 12-Item Short-Form Health Survey (SF-12)

  10 weeks from baseline

• 12-Item Short-Form Health Survey (SF-12)

  5 months from baseline

• 12-Item Short-Form Health Survey (SF-12)

  8 months from baseline

• Symptom Checklist (SCL)

  baseline

Other Outcomes (23)

• Patient Health Questionnaire-9 (PHQ-9)

  baseline

• Patient Health Questionnaire-9 (PHQ-9)

  10 weeks from baseline

• Patient Health Questionnaire-9 (PHQ-9)

  5 months from baseline

Study Arms (1)

PVC-specific CBT

OTHER

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.

Behavioral: CBT

Interventions

CBT BEHAVIORAL

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

PVC-specific CBT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

• Liliequist BE, Sarnholm J, Skuladottir H, Olafsdottir E, Ljotsson B, Braunschweig F. Cognitive Behavioral Therapy for Symptom Preoccupation Among Patients With Premature Ventricular Contractions: Nonrandomized Pretest-Posttest Study. JMIR Cardio. 2024 May 7;8:e53815. doi: 10.2196/53815.

  PMID: 38713500 DERIVED

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frieder Braunschweig

  Karolinska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: October 21, 2021
• Study Start: January 14, 2021
• Primary Completion: November 5, 2021
• Study Completion: May 10, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

SE (1)