CBT for Premature Ventricular Contractions

NCT ID: NCT05087238

Last Updated: 2022-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2022-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Premature Complexes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PVC-specific 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.

Group Type OTHER

CBT

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Frieder Braunschweig

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frieder Braunschweig

Role: PRINCIPAL_INVESTIGATOR

Karolinska

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38713500 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PVC-CBT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Fetal EKG Study
NCT02320279 UNKNOWN