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Effectiveness of an Anger and Stress Management Program on Reducing Blood Pressure Levels in Youth

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. Identifier: NCT00508612
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : July 12, 2016
Williams LifeSkills
Information provided by (Responsible Party):
, National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
High blood pressure can often be caused by stress or anxiety. This study will evaluate a school-based stress and anger management program that aims to lower blood pressure and anger levels among high school students.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Hypertension Behavioral: Williams LifeSkills Stress and Anger Management Workshop Behavioral: High school classes Phase 2

Detailed Description:

High blood pressure can be caused by many factors, including stress, anxiety, diabetes, kidney disease, or obesity. In many people, there is no identifiable cause for their high blood pressure; this is known as essential hypertension (EH). Increasingly, children are being diagnosed with high blood pressure, which may lead to an increased risk of developing EH as adults. Therefore, the need exists for an effective blood pressure reduction program targeted toward youth. Research has shown that improving people's abilities to manage stress and anger reduces their risk of developing high blood pressure and heart disease. The Williams LifeSkills (WLS) workshop is a program that teaches people to cope with stressful situations. It has been shown to improve heart health, including blood pressure levels, in adults with cardiovascular disease. However, the effect of stress and anger management programs on blood pressure levels in youth has not been widely studied. Study researchers have developed and preliminarily tested a school-based anger and stress management WLS program. This study will evaluate the effectiveness of the school-based WLS program at reducing blood pressure and anger levels in high school students. If successful, this program could be implemented in schools across the country.

This study will enroll high school students. Participants will be randomly assigned to either a 12 lesson WLS program or a control group. Participants in the control group will attend regular high school classes. Participants in the WLS program will attend 12 sessions that will focus on coping skills to help manage stress and anger levels. At baseline, the end of the 12 lesson program, and follow-up visits 3 and 6 months later, participants will complete questionnaires on anger levels; life skills; hostility; stress; self-esteem; and attitudes toward school, teachers, and parents. They will also wear a blood pressure monitor for a 24-hour period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Impact of LifeSkills Training on Blood Pressure in Youth
Study Start Date : April 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
The 12-lesson Williams LifeSkills anger and stress management workshop (WLS) enhances awareness of thoughts and feelings in stressful situations, and provides training in evaluation, deflection, problem-solving, assertion, saying no, speaking, listening, empathy, and emphasizing positives.
Behavioral: Williams LifeSkills Stress and Anger Management Workshop
Williams LifeSkills Stress and Anger Management Workshop

Placebo Comparator: 2
Control group (will attend regular high school classes)
Behavioral: High school classes
The control group will attend regular high school classes.

Primary Outcome Measures :
  1. Reduction in day-time ambulatory systolic blood pressure [ Time Frame: Measured at post-intervention after the 12 lesson program and at 3- and 6-month follow-up visits ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • High school student

Exclusion Criteria:

  • History of any chronic illness or any chronic health problem requiring pharmacological treatment (e.g., asthma, sickle cell disease, epilepsy)
  • Adolescents with ambulatory systolic blood pressure greater than the 95th percentile based on age, sex, and height at screening will be allowed to participate in the workshop but may be excluded from testing
  • Unwilling to be assigned into a specific treatment group

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00508612

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United States, Georgia
Richmond County Board of Education Public Schools
Augusta, Georgia, United States, 30901
Medical College of Georgia - Georgia Prevention Institute
Augusta, Georgia, United States, 30912
United States, North Carolina
Williams LifeSkills
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Williams LifeSkills
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Principal Investigator: Vernon A. Barnes, PhD Medical College of Georgia - Georgia Prevention Institute
Principal Investigator: Virginia P. Williams, PhD Williams LifeSkills
Additional Information:
Publications of Results:
Barnes VA, Williams VP, Williams RB. Effects of Williams LifeSkills training on anger reduction in African American adolescents. Psychosomatic Medicine. 2005;67:A53.
Barnes VA, Williams VP, Williams RB, Johnson MH, Stevens AM, Shenbagarajan VP. Effect of Williams Lifeskills training on anger control in African American adolescents (abstract 014). Paper presented at: ISHIB2008: 23rd Annual International Interdisciplinary Conference on Hypertension and Related Cardiovascular Risk Factors in Ethnic Populations, 2008; New Orleans, LA.
Barnes VA, Williams VP, Williams RB, Johnson MH, Murrell AS, Shenbagarajan VP, Dubert C. Williams Lifeskills® training lowers school-time ambulatory blood pressure in adolescents. Paper accepted for presentation at: Society of Behavioral Medicine Annual Meeting April 22-25, 2009; Montreal, Canada.
Barnes VA, Williams VP, Williams RB, Shenbagarajan VP, Bentley DR, Johnson MH. Effect of Williams Lifeskills Training on Anger and Anxiety in Adolescents. Psychosomatic Medicine. 2010;72(3):A70.

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Responsible Party: , Assistant Professor, National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT00508612    
Other Study ID Numbers: 497
R42HL072644-02A2 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: March 2013
Keywords provided by , National Heart, Lung, and Blood Institute (NHLBI):
Blood Pressure
Systolic Blood Pressure
Diastolic Blood Pressure
Ambulatory Blood Pressure Monitoring
Coping Skills
Additional relevant MeSH terms:
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Cardiovascular Diseases