Clinical trial NCT05087238: CBT for Premature Ventricular Contractions
Official title: Cognitive Behavior Therapy for Patients With Premature Ventricular Contractions - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Premature Complexes
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2021-10-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
timeFrame: baseline
measure: Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
timeFrame: 10 weeks from baseline
measure: Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
timeFrame: 5 months from baseline
measure: Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
timeFrame: 8 months from baseline
Secondary outcomes:
measure: 12-Item Short-Form Health Survey (SF-12)
timeFrame: baseline
measure: 12-Item Short-Form Health Survey (SF-12)
timeFrame: 10 weeks from baseline
measure: 12-Item Short-Form Health Survey (SF-12)
timeFrame: 5 months from baseline
measure: 12-Item Short-Form Health Survey (SF-12)
timeFrame: 8 months from baseline
measure: Symptom Checklist (SCL)
timeFrame: baseline
measure: Symptom Checklist (SCL)
timeFrame: 10 weeks from baseline
measure: Symptom Checklist (SCL)
timeFrame: 5 months from baseline
measure: Symptom Checklist (SCL)
timeFrame: 8 months from baseline
measure: Arrhythmia burden
timeFrame: baseline
measure: Arrhythmia burden
timeFrame: 10 weeks from baseline
measure: Arrhythmia burden
timeFrame: 8 months from baseline
measure: Cardiac anxiety questionnaire (CAQ)
timeFrame: baseline
measure: Cardiac anxiety questionnaire (CAQ)
timeFrame: 10 weeks from baseline
measure: Cardiac anxiety questionnaire (CAQ)
timeFrame: 5 months from baseline
measure: Cardiac anxiety questionnaire (CAQ)
timeFrame: 8 months from baseline
Other outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 10 weeks from baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 5 months from baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 8 months from baseline
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: baseline
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: 10 weeks from baseline
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: 5 months from baseline
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: 8 months from baseline
measure: Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)
timeFrame: baseline
measure: Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)
timeFrame: 10 weeks from baseline
measure: Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)
timeFrame: 5 months from baseline
measure: Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)
timeFrame: 8 months from baseline
measure: Body Sensation Questionnaire (BSQ)
timeFrame: baseline
measure: Body Sensation Questionnaire (BSQ)
timeFrame: 10 weeks from baseline
measure: Body Sensation Questionnaire (BSQ)
timeFrame: 5 months from baseline
measure: Body Sensation Questionnaire (BSQ)
timeFrame: 8 months from baseline
measure: Client satisfaction Questionnaire (CSQ)
timeFrame: 10 weeks from baseline
measure: The Perceived stress scale (PSS-10)
timeFrame: baseline
measure: The Perceived stress scale (PSS-10)
timeFrame: 10 weeks from baseline
measure: The Perceived stress scale (PSS-10)
timeFrame: 5 months from baseline
measure: The Perceived stress scale (PSS-10)
timeFrame: 8 months from baseline
measure: Treatment Credibility Scale (TCS)
timeFrame: Will be measured 2 weeks from baseline
measure: Adverse events
timeFrame: 10 weeks from baseline
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska
name: Frieder Braunschweig
role: PRINCIPAL_INVESTIGATOR
References: