Ventricular ArrhythmiaPAM-ICDNCT02088619
Positive Therapy for Autonomic Function & Mood in ICD Patients
A study testing Quality of Life Therapy (QOLT) and Heart Healthy Education (HHE) in people with Ventricular Arrhythmia and Implantable Cardioverter Defibrillator, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmia, Implantable Cardioverter Defibrillator
- What is being tested?
- Quality of Life Therapy (QOLT) and Heart Healthy Education (HHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women (≥18 years of age) who have received an ICD for primary or secondary prevention of sudden cardiac death. All patients will have systolic left ventricular dysfunction due to coronary disease or nonischemic cardiomyopathy. There is no requirement for time since implant;
- Score ≥5 on the Hospital Anxiety and Depression Scale (HADS) anxiety or depression scales;
- Able to read and write English
- Able to commit to the 3-month QOLT/HHE program and 3 assessments over a 9-month duration.
Who cannot join
- >5% atrial or ventricular pacing;
- Sinus node dysfunction;
- Persistent and permanent atrial fibrillation (AF) (h/o of paroxysmal AF will be allowed).
- Long QT syndrome; and other channelopathies such as Brugada syndrome;
- Hypertrophic cardiomyopathy;
- Neurocognitive or cognitive impairments;
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- Severe psychopathology that warrants intensive treatment;
- Participation in another research trial; and
- Currently in psychological or psychiatric treatment.
- Current psychotropic and cardiac medication prescriptions and usage need to be stable (i.e., no change in type or dosage) for 3-months prior to study enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine
Charleston, South Carolina, 29425
About this study
Official title: Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients
The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 \& 9-months). It is hypothesized that the QOLT will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.
- Being tested
- Quality of Life Therapy (QOLT), Heart Healthy Education (HHE)
- Keywords
- psychological wellbeing, anxiety, depression, autonomic functioning
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life Therapy (QOLT)Behavioural
Heart Healthy Education (HHE)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Quality of Life Therapy (QOLT) | Experimental | Positive emotion-focused cognitive behavioral psychotherapy Receives: Behavioral: Quality of Life Therapy (QOLT) |
| Heart Healthy Education (HHE) | Active comparator | Heart healthy education program Receives: Behavioral: Heart Healthy Education (HHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of arrhythmias between baseline and 3-months
Total arrhythmia frequencies between baseline and 3-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at >120 beats per minute [BPM] ) plus arrhythmias detected by the ICD
Measured: 3-months
Frequency of arrhythmias between 3-months and 9-months
Total arrhythmia frequencies between 3-months and 9-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at >120 BPM ) plus arrhythmias detected by the ICD
Measured: 9-months
Secondary outcomes (4)
Frequency of ICD therapies between baseline and 3-months
Obtained from ICD interrogation reports from recording between baseline and 3-months
Measured: 3-months
Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months
Index of parasympathetic activity; obtained from 24-hour Holter recording
Measured: 3-months
Frequency of ICD therapies between 3-months and 9-months
Obtained from ICD interrogation reports between 3- and 9-months
Measured: 9-months
Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months
Index of parasympathetic activity; obtained from 24-hour Holter recording
Measured: 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2017
- Study completionJan 2017
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 ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Eva R Serber, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088619
- Sponsor's protocol ID
- Pro00028869
- Other IDs
- 1R34HL107733-01A1
- Acronym
- PAM-ICD
- Status last verified
- Sep 2017
- First submitted
- 18 Feb 2014
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Frisch M. Quality of Life Therapy; Applying a Life Satisfaction Approach to Positive Psychology and Cognitive Therapy. Hobokon, NJ: John Wiley & Sons, Inc.; 2006.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients
- ClinicalTrials.gov ID
- NCT02088619
- Acronym / sponsor ID
- PAM-ICD / Pro00028869
- Keywords
- psychological wellbeing, anxiety, depression, autonomic functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Mar 2014 (estimated)
- 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 this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 \& 9-months). It is hypothesized that the QOLT will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quality of Life Therapy (QOLT) | Experimental | Behavioral: Quality of Life Therapy (QOLT)Positive emotion-focused cognitive behavioral psychotherapy |
| Heart Healthy Education (HHE) | Active comparator | Behavioral: Heart Healthy Education (HHE)Heart healthy education program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men and women (≥18 years of age) who have received an ICD for primary or secondary prevention of sudden cardiac death. All patients will have systolic left ventricular dysfunction due to coronary disease or nonischemic cardiomyopathy. There is no requirement for time since implant;
- Score ≥5 on the Hospital Anxiety and Depression Scale (HADS) anxiety or depression scales;
- Able to read and write English
- Able to commit to the 3-month QOLT/HHE program and 3 assessments over a 9-month duration.
Key exclusion criteria (10 listed)
- >5% atrial or ventricular pacing;
- Sinus node dysfunction;
- Persistent and permanent atrial fibrillation (AF) (h/o of paroxysmal AF will be allowed).
- Long QT syndrome; and other channelopathies such as Brugada syndrome;
- Hypertrophic cardiomyopathy;
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 |
|---|---|---|
| Quality of Life Therapy (QOLT) | Behavioural | Quality of Life Therapy (QOLT) |
| Heart Healthy Education (HHE) | Behavioural | Heart Healthy Education (HHE) |
Primary outcome
Frequency of arrhythmias between baseline and 3-months
Time frame: 3-months
Total arrhythmia frequencies between baseline and 3-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at >120 beats per minute [BPM] ) plus arrhythmias detected by the ICD
Frequency of arrhythmias between 3-months and 9-months
Time frame: 9-months
Total arrhythmia frequencies between 3-months and 9-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at >120 BPM ) plus arrhythmias detected by the ICD
4 secondary outcomes
Frequency of ICD therapies between baseline and 3-months
Time frame: 3-months
Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months
Time frame: 3-months
Frequency of ICD therapies between 3-months and 9-months
Time frame: 9-months
Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months
Time frame: 9-months
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 2 Oct 2017.
- BackgroundFrisch M. Quality of Life Therapy; Applying a Life Satisfaction Approach to Positive Psychology and Cognitive Therapy. Hobokon, NJ: John Wiley & Sons, Inc.; 2006.
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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.
Eva R Serber, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life Therapy (QOLT) and Heart Healthy Education (HHE) in people with Ventricular Arrhythmia and Implantable Cardioverter Defibrillator, run by Medical University of South Carolina at 1 site in United States.
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 10 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 2 Oct 2017. 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 United States. 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?
Frequency of arrhythmias between baseline and 3-months (time frame: 3-months). The study lists 2 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 NCT02088619, 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 2 Oct 2017.