Ventricular Premature ComplexesPVC-CBTNCT05087238
CBT for Premature Ventricular Contractions
A study testing CBT in people with Ventricular Premature Complexes, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventricular Premature Complexes
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jan 2021to 10 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavior Therapy for Patients With Premature Ventricular Contractions - a Pilot Study
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).
Read the 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.
- Conditions
- Ventricular Premature Complexes
- Being tested
- CBT
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Cognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 8 months from baseline
Secondary outcomes (15)
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: baseline
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: 10 weeks from baseline
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: 5 months from baseline
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: 8 months from baseline
Symptom Checklist (SCL)
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
Measured: baseline
Symptom Checklist (SCL)
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
Measured: 10 weeks from baseline
Symptom Checklist (SCL)
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
Measured: 5 months from baseline
Symptom Checklist (SCL)
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
Measured: 8 months from baseline
Arrhythmia burden
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
Measured: baseline
Arrhythmia burden
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
Measured: 10 weeks from baseline
Arrhythmia burden
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
Measured: 8 months from baseline
Cardiac anxiety questionnaire (CAQ)
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: baseline
Cardiac anxiety questionnaire (CAQ)
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: 10 weeks from baseline
Cardiac anxiety questionnaire (CAQ)
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: 5 months from baseline
Cardiac anxiety questionnaire (CAQ)
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: 8 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start14 Jan 2021
- Primary completion5 Nov 2021
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular Premature ComplexesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Frieder Braunschweig, Karolinska Institutet
- Investigators
- Frieder Braunschweig, Principal investigator, Karolinska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087238
- Sponsor's protocol ID
- PVC-CBT
- Acronym
- PVC-CBT
- Status last verified
- Aug 2022
- First submitted
- 24 Jun 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38713500
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy for Patients With Premature Ventricular Contractions - a Pilot Study
- ClinicalTrials.gov ID
- NCT05087238
- Acronym / sponsor ID
- PVC-CBT / PVC-CBT
- Conditions
- Ventricular Premature Complexes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVC-specific CBT | Other | Behavioral: CBTThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTCognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention | Behavioural | PVC-specific CBT |
Primary outcome
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
Time frame: 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)
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
Time frame: 10 weeks 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)
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
Time frame: 5 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)
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)
15 secondary outcomes
12-Item Short-Form Health Survey (SF-12)
Time frame: baseline
12-Item Short-Form Health Survey (SF-12)
Time frame: 10 weeks from baseline
12-Item Short-Form Health Survey (SF-12)
Time frame: 5 months from baseline
12-Item Short-Form Health Survey (SF-12)
Time frame: 8 months from baseline
Symptom Checklist (SCL)
Time frame: baseline
Symptom Checklist (SCL)
Time frame: 10 weeks from baseline
Symptom Checklist (SCL)
Time frame: 5 months from baseline
Symptom Checklist (SCL)
Time frame: 8 months from baseline
Arrhythmia burden
Time frame: baseline
Arrhythmia burden
Time frame: 10 weeks from baseline
Arrhythmia burden
Time frame: 8 months from baseline
Cardiac anxiety questionnaire (CAQ)
Time frame: baseline
Cardiac anxiety questionnaire (CAQ)
Time frame: 10 weeks from baseline
Cardiac anxiety questionnaire (CAQ)
Time frame: 5 months from baseline
Cardiac anxiety questionnaire (CAQ)
Time frame: 8 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Derived from this study: PubMed 38713500Liliequist 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frieder Braunschweig principal investigator
Karolinska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Ventricular Premature Complexes, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05087238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.