Cardiomyopathy, DilatedPhase 3NCT00624520
Mental Stress Reduction in Defibrillator Patients
A Phase 3 study testing Cognitive Behavioral Stress Management (CBSM) and Patient Education in people with Cardiomyopathy, Dilated and Arrhythmia, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Cardiomyopathy, Dilated, Arrhythmia, Anger
- What is being tested?
- Cognitive Behavioral Stress Management (CBSM) and Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Jul 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >21 years,
- ICD Implantation,
- > 3 months following ICD implantation,
- willingness to give informed consent
Who cannot join
- Episodes within prior 3 months of: acute coronary syndrome, myocardial infraction, Coronary Artery By-pass Graft surgery, percutaneous coronary intervention, hospital admission any cause,
- severe mental illness,
- life expectancy < 1 year,
- hyperkalemia,
- hypokalemia,
- hypomagnesemia,
- hypermagnesemia,
- unwillingness to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, 53295-1000
About this study
Official title: Effectiveness of Mental Stress Reduction in Defibrillator Patients
The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators
Read the detailed description
The study is a randomized controlled small clinical trial designed to determine whether a 10-week program of group cognitive-behavioral stress management (CBSM) versus a control "Patient Education" program can improve hemodynamic responses to mental stress testing in patients with Implantable Cardioverter Defibrillators. Comparison will be made between groups of heart rate and blood pressure responses to mental arithmetic and anger-recall mental stress, psychometric profiles, arrhythmia frequency and implantable cardioverter defibrillator firings before, immediately and up to 6 months after intervention. If benefit of CBSM is proven, study findings could lead to wider use of stress management programs, with increased life expectancy for implantable cardioverter-defibrillator patients.
- Conditions
- Cardiomyopathy, Dilated, Arrhythmia, Anger, Stress
- Being tested
- Cognitive Behavioral Stress Management (CBSM), Patient Education
- Keywords
- Stress, Psychological, Tachycardia, Ventricular, Defibrillators, Implantable, Death, Sudden Cardiac, Cognitive Therapy, Anger
- Medical subject headings
- Cardiomyopathy, Dilated, Arrhythmias, Cardiac, Stress, Psychological, Tachycardia, Ventricular, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Stress Management (CBSM)Behavioural
10 week program of weekly CBSM therapy group sessions
Patient EducationOther
10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Stress Management | Active comparator | 10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions Receives: Behavioral: Cognitive Behavioral Stress Management (CBSM) |
| Patient Education | Active comparator | 10 week program of once weekly Patient Education group sessions Receives: Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Stress Induced Elevation in "Double Product" by Math Stress Task
Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.
Measured: Immediate to 6 months post intervention
Mental Stress Induced Elevation in Double Product by Math Stress Task
Maximum Mental Stress induced elevation in "Double Product" , DP, (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress tasks of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.
Measured: 3 months post intervention
Mental Stress Induced Elevation in "Double Product" by Anger-recall Task
Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress of anger-recall task. Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The anger-recall test was applied for 25 minutes with 10 minutes monitoring post-test. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect
Measured: Immediate to 6 months post intervention
Secondary outcomes (8)
State Anger
Psychosocial score of negative mood derived from self-report questionnaires. Scale range was 15-45. Lower values represent better outcome, and higher values represent worse outcome..
Measured: Immediate post intervention
Tension/Anxiety
Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..
Measured: Immediate post intervention
Perceived Stress
Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..
Measured: Immediate post intervention
Depression/Dejection
Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..
Measured: 3 months post intervention
Low Frequency Heart Rate Variability
Heart Rate Variability measure of cardiac autonomic activity, believed to reflect a combination of cardiac sympathetic and parasympathetic activity.
Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Low frequency heart rate variability correlates with cardiac sympathetic and parasympathetic activity. Increased sympathetic activity and/or decreased parasympathetic activity occur in this study population at high risk for cardiac arrhythmia. Normalized units are used, reflecting percentage of total frequency power.
Measured: 6 months post intervention
High Frequency Heart Rate Variability
Heart Rate Variability measure of Cardiac Parasympathetic activity. Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Increased High Frequency heart rate variability correlates with increased cardiac parasympathetic activity. Normalized units are used, reflecting percentage of total frequency power.
Measured: 6 months post intervention
Low Frequency/High Frequency Ratio of Heart Rate Variability
Heart Rate Variability measure of cardiac autonomic activity Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Decreased Low/High Frequency ratio reflects Increased High Frequency heart rate variability which correlates with increased cardiac parasympathetic activity, which may be beneficial in this patient population. Normalized units are used, reflecting percentage of total frequency power.
Measured: 6 months post intervention
Cardioverter-DefibrillatorTherapies
Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionJul 2014
Why it stopped: Exhaustion of subject population pool, greater than expected drop-out rates . Data analysis approved by DMC for study completions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiomyopathy, DilatedStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Douglas Russell, MD PhD, Principal investigator, Wlliam S. Middleton Memorial Veterans Hospital, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624520
- Sponsor's protocol ID
- CLIN-008-07F
- Status last verified
- Dec 2014
- First submitted
- 14 Feb 2008
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Russell DC, Smith TL, Krahn DD, Graskamp P, Singh D, Kolden GG, Sigmund H, Zhang Z. Effects of Cognitive Behavioral Stress Management on Negative Mood and Cardiac Autonomic Activity in ICD Recipients. Pacing Clin Electrophysiol. 2015 Aug;38(8):951-65. doi: 10.1111/pace.12668. Epub 2015 Jun 20.
PubMed 26010524
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mental Stress Reduction in Defibrillator Patients
- ClinicalTrials.gov ID
- NCT00624520
- Acronym / sponsor ID
- CLIN-008-07F
- Conditions
- Cardiomyopathy, Dilated, Arrhythmia, Anger, Stress
- Keywords
- Stress, Psychological, Tachycardia, Ventricular, Defibrillators, Implantable, Death, Sudden Cardiac, Cognitive Therapy, Anger
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Exhaustion of subject population pool, greater than expected drop-out rates . Data analysis approved by DMC for study completions
- Enrolment
- 129 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Posted 22 Dec 2014
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 study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators
Detailed description
The study is a randomized controlled small clinical trial designed to determine whether a 10-week program of group cognitive-behavioral stress management (CBSM) versus a control "Patient Education" program can improve hemodynamic responses to mental stress testing in patients with Implantable Cardioverter Defibrillators. Comparison will be made between groups of heart rate and blood pressure responses to mental arithmetic and anger-recall mental stress, psychometric profiles, arrhythmia frequency and implantable cardioverter defibrillator firings before, immediately and up to 6 months after intervention. If benefit of CBSM is proven, study findings could lead to wider use of stress management programs, with increased life expectancy for implantable cardioverter-defibrillator patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Stress Management | Active comparator | Behavioral: Cognitive Behavioral Stress Management (CBSM)10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions |
| Patient Education | Active comparator | Other: Patient Education10 week program of once weekly Patient Education group sessions |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >21 years,
- ICD Implantation,
- > 3 months following ICD implantation,
- willingness to give informed consent
Key exclusion criteria (8 listed)
- Episodes within prior 3 months of: acute coronary syndrome, myocardial infraction, Coronary Artery By-pass Graft surgery, percutaneous coronary intervention, hospital admission any cause,
- severe mental illness,
- life expectancy < 1 year,
- hyperkalemia,
- hypokalemia,
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 |
|---|---|---|
| Cognitive Behavioral Stress Management (CBSM)10 week program of weekly CBSM therapy group sessions | Behavioural | Cognitive Behavioral Stress Management |
| Patient Education10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease. | Other | Patient Education |
Primary outcome
Mental Stress Induced Elevation in "Double Product" by Math Stress Task
Time frame: Immediate to 6 months post intervention
Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.
Mental Stress Induced Elevation in Double Product by Math Stress Task
Time frame: 3 months post intervention
Maximum Mental Stress induced elevation in "Double Product" , DP, (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress tasks of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.
Mental Stress Induced Elevation in "Double Product" by Anger-recall Task
Time frame: Immediate to 6 months post intervention
Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress of anger-recall task. Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The anger-recall test was applied for 25 minutes with 10 minutes monitoring post-test. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect
8 secondary outcomes
State Anger
Time frame: Immediate post intervention
Tension/Anxiety
Time frame: Immediate post intervention
Perceived Stress
Time frame: Immediate post intervention
Depression/Dejection
Time frame: 3 months post intervention
Low Frequency Heart Rate Variability
Time frame: 6 months post intervention
High Frequency Heart Rate Variability
Time frame: 6 months post intervention
Low Frequency/High Frequency Ratio of Heart Rate Variability
Time frame: 6 months post intervention
Cardioverter-DefibrillatorTherapies
Time frame: 6 months post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26010524Russell DC, Smith TL, Krahn DD, Graskamp P, Singh D, Kolden GG, Sigmund H, Zhang Z. Effects of Cognitive Behavioral Stress Management on Negative Mood and Cardiac Autonomic Activity in ICD Recipients. Pacing Clin Electrophysiol. 2015 Aug;38(8):951-65. doi: 10.1111/pace.12668. Epub 2015 Jun 20.
Related trials for Cardiomyopathy, Dilated
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
Active, not recruiting
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Heart Failure, Left Ventricular Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Heart Failure, Ischemic Heart Failure
RecruitingObservational study
Observational Study of Natural History of BAG3 Gene Mutation-Associated Dilated Cardiomyopathy in Chinese Adults
Dilated Cardiomyopathy
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.
Douglas Russell, MD PhD principal investigator
Wlliam S. Middleton Memorial Veterans Hospital, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioral Stress Management (CBSM) and Patient Education in people with Cardiomyopathy, Dilated and Arrhythmia, run by US Department of Veterans Affairs at 2 sites 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 8 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: stopped early, as of the sponsor's last update on 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mental Stress Induced Elevation in "Double Product" by Math Stress Task (time frame: Immediate to 6 months post intervention). The study lists 3 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 NCT00624520, 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 22 Dec 2014.