Effectiveness of an Anger and Stress Management Program on Reducing Blood Pressure Levels in Youth
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|ClinicalTrials.gov Identifier: NCT00508612|
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Hypertension||Behavioral: Williams LifeSkills Stress and Anger Management Workshop Behavioral: High school classes||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||259 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00508612
|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|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Vernon A. Barnes, PhD||Medical College of Georgia - Georgia Prevention Institute|
|Principal Investigator:||Virginia P. Williams, PhD||Williams LifeSkills|