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Mental Stress Reduction in Defibrillator Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00624520
Recruitment Status : Terminated (Exhaustion of subject population pool, greater than expected drop-out rates . Data analysis approved by DMC for study completions)
First Posted : February 27, 2008
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cardiomyopathy, Dilated
Arrhythmia
Anger
Stress
Interventions Behavioral: Cognitive Behavioral Stress Management (CBSM)
Other: Patient Education
Enrollment 129
Recruitment Details Recruitment commenced October 2009, completed December 2011 Recruitment from Cardiology Clinics W S Middleton Veterans Hospital, Madison, and Zablocki VA Medical Center, Milwaukee
Pre-assignment Details Some enrolled participants were excluded from the trial if determined to have severe mental illness after administration of an SCID-I questionnaire and/or interview by a clinical psychologist. Others were excluded as drop-outs due to travel issues, weather, family issues, and illness. 2 subjects died before group assignment.
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Period Title: Overall Study
Started 56 47
Completed 44 39
Not Completed 12 8
Reason Not Completed
Withdrawal by Subject             12             7
Death             0             1
Arm/Group Title Cognitive Behavioral Stress Management Patient Education Total
Hide Arm/Group Description

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Total of all reporting groups
Overall Number of Baseline Participants 56 47 103
Hide Baseline Analysis Population Description
Subjects randomized , including drop-outs before commencement of intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 47 participants 103 participants
65.7  (9.0) 66.2  (8.6) 65.7  (8.9)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 47 participants 103 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
  57.1%
23
  48.9%
55
  53.4%
>=65 years
24
  42.9%
24
  51.1%
48
  46.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 47 participants 103 participants
Female
0
   0.0%
1
   2.1%
1
   1.0%
Male
56
 100.0%
46
  97.9%
102
  99.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 47 participants 103 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   8.9%
6
  12.8%
11
  10.7%
White
51
  91.1%
41
  87.2%
92
  89.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 47 participants 103 participants
Hispanic or Latino
0
   0.0%
2
   4.3%
2
   1.9%
Not Hispanic or Latino
56
 100.0%
45
  95.7%
101
  98.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 56 participants 47 participants 103 participants
56 47 103
[1]
Measure Description: Madison and Milwaukee study sites, US
1.Primary Outcome
Title Mental Stress Induced Elevation in "Double Product" by Math Stress Task
Hide Description 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.
Time Frame Immediate to 6 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Response to Mental Stress by Math Stress Task.
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 43 38
Mean (Standard Error)
Unit of Measure: mmHg x beats/min
6 months post 1693  (343) 1137  (228)
3 months post 1399  (201) 1063  (158)
Immediate post 1514  (246) 1538  (224)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in "Double Product" response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 891
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mental Stress Induced Elevation in Double Product by Math Stress Task
Hide Description 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.
Time Frame 3 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Response to mental stress by math task testing at 3 months post intervention, compared with pre-intervention. Within-group comparison is shown for matched pair data. The lower number of participants analyzed than at study entry is due to patient drop-outs during follow-up post-intervention.
Arm/Group Title Cognitive Behavioral Stress Management
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

Overall Number of Participants Analyzed 36
Mean (Standard Error)
Unit of Measure: mmHg x beats/minute
Pre intervention 1915  (263)
3 months post intervention 1399  (201)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments P-value refers to a repeated measures within-group comparison in the CBSM group using ANCOVA with baseline DP elevation as covariate from baseline to 3 months post.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size (Cohen's d)
Estimated Value 0.38
Estimation Comments Range of Cohen's d for small effect is 0.20 - 0.50
3.Primary Outcome
Title Mental Stress Induced Elevation in "Double Product" by Anger-recall Task
Hide Description 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
Time Frame Immediate to 6 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Response to Mental Stress by Anger-Recall Stress Task
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 44 39
Mean (Standard Error)
Unit of Measure: mmHg x beats/minute
6 months post intervention 711  (232) 631  (292)
3 months post intervention 353  (167) 548  (308)
Immediate post intervention 406  (93) 681  (244)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in "Double Product" response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 80
Estimation Comments [Not Specified]
4.Secondary Outcome
Title State Anger
Hide Description 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..
Time Frame Immediate post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Serial psychometric scores up to 6 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 39 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
16  (2) 19  (7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Tension/Anxiety
Hide Description Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..
Time Frame Immediate post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 39 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
8  (4) 12  (7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Perceived Stress
Hide Description Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..
Time Frame Immediate post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 39 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
10  (6) 14  (8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Depression/Dejection
Hide Description Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..
Time Frame 3 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
3 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up,with inclusion only of participants having accurate and appropriate data.
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
20  (6) 24  (11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Low Frequency Heart Rate Variability
Hide Description

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.

Time Frame 6 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
6 months post intervention, from ECG recordings during mental stress tasks Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for HRV analyses during follow-up, with inclusion only of participants having accurate and appropriate data.
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 17 23
Mean (Standard Deviation)
Unit of Measure: percentage of spectral power
59  (19) 70  (21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11
Estimation Comments [Not Specified]
9.Secondary Outcome
Title High Frequency Heart Rate Variability
Hide Description 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.
Time Frame 6 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Reduced participant numbers reflect drop-outs and exclusion of participants with non-diagnostic recordings for HRV analyses, with inclusion only of participants having accurate and appropriate data.
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 17 23
Mean (Standard Deviation)
Unit of Measure: percentage of spectral power
41  (19) 26  (16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Low Frequency/High Frequency Ratio of Heart Rate Variability
Hide Description 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.
Time Frame 6 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description

Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for heart rate variability analyses during follow-up, with inclusion only of participants having accurate and appropriate data.

Data are shown for Ratios of Low and High Frequency power shown above.

Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 17 23
Mean (Standard Deviation)
Unit of Measure: Ratio
1.99  (1.47) 4.01  (3.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.02
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Cardioverter-DefibrillatorTherapies
Hide Description Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia
Time Frame 6 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Cardioverter-defibrillator interrogation data between 3 and 6 months post intervention
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description:

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Overall Number of Participants Analyzed 38 33
Measure Type: Number
Unit of Measure: percentage of participants
0 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Stress Management, Patient Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 6 to 12 months, from enrollment to study completion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Behavioral Stress Management Patient Education
Hide Arm/Group Description

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions

10 week program of once weekly Patient Education group sessions

Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

All-Cause Mortality
Cognitive Behavioral Stress Management Patient Education
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Behavioral Stress Management Patient Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/56 (16.07%)      12/47 (25.53%)    
Cardiac disorders     
Death * [1]  0/56 (0.00%)  0 1/47 (2.13%)  1
Atrial flutter * [2]  2/56 (3.57%)  2 0/47 (0.00%)  0
Ventricular tachycardia *  0/56 (0.00%)  0 1/47 (2.13%)  2
Tachycardia * [3]  0/56 (0.00%)  0 1/47 (2.13%)  1
Heart Failure *  0/56 (0.00%)  0 1/47 (2.13%)  1
Dizziness * [4]  1/56 (1.79%)  2 2/47 (4.26%)  2
Implantable Defibrillator malfunction * [5]  2/56 (3.57%)  3 1/47 (2.13%)  1
Gastrointestinal disorders     
Diverticulitis *  0/56 (0.00%)  0 1/47 (2.13%)  1
Esophageal stricture *  0/56 (0.00%)  0 1/47 (2.13%)  1
Abdominal pain * [6]  0/56 (0.00%)  0 1/47 (2.13%)  1
Diarrhea *  0/56 (0.00%)  0 1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia * [7]  2/56 (3.57%)  2 0/47 (0.00%)  0
Nasal polyps * [8]  1/56 (1.79%)  1 0/47 (0.00%)  0
Vascular disorders     
Carotid artery disease * [9]  1/56 (1.79%)  1 0/47 (0.00%)  0
Cerebrovascular Disease *  0/56 (0.00%)  0 1/47 (2.13%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Cardiomyopathy, sudden cardiac death
[2]
Includes Ablation procedures
[3]
Tachycardia unknown origin
[4]
Includes syncope, dizziness, hypotension
[5]
Includes admissions for inappropriate device firings, lead revisions
[6]
Includes colonoscopy
[7]
includes respiratory infection
[8]
Includes nasal polypectomy
[9]
Includes carotid artery surgery
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cognitive Behavioral Stress Management Patient Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      0/47 (0.00%)    
Early termination of study after 12 month study extension and interim data analysis, due to high drop-out rate and exhaustion of population pool, 9 subjects short of revised target enrollment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Douglas C Russell
Organization: Department of Veterans Affairs
Phone: 608-256-1901
EMail: Dcrussel@facstaff.wisc.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00624520     History of Changes
Other Study ID Numbers: CLIN-008-07F
First Submitted: February 14, 2008
First Posted: February 27, 2008
Results First Submitted: November 19, 2014
Results First Posted: December 22, 2014
Last Update Posted: December 22, 2014