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

NCT ID: NCT00508612

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Williams LifeSkills Stress and Anger Management Workshop

Intervention Type BEHAVIORAL

Williams LifeSkills Stress and Anger Management Workshop

2

Control group (will attend regular high school classes)

Group Type PLACEBO_COMPARATOR

High school classes

Intervention Type BEHAVIORAL

The control group will attend regular high school classes.

Interventions

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Williams LifeSkills Stress and Anger Management Workshop

Williams LifeSkills Stress and Anger Management Workshop

Intervention Type BEHAVIORAL

High school classes

The control group will attend regular high school classes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Williams LifeSkills

INDUSTRY

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Responsible Party

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Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vernon A. Barnes, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Georgia - Georgia Prevention Institute

Virginia P. Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

Williams LifeSkills

Locations

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Richmond County Board of Education Public Schools

Augusta, Georgia, United States

Site Status

Medical College of Georgia - Georgia Prevention Institute

Augusta, Georgia, United States

Site Status

Williams LifeSkills

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Barnes VA, Williams VP, Williams RB. Impact of Williams LifeSkills training on blood pressure in adolescents. Psychosomatic Medicine. 2005;67:A78.

Reference Type RESULT

Barnes VA, Williams VP, Williams RB. Effects of Williams LifeSkills training on anger reduction in African American adolescents. Psychosomatic Medicine. 2005;67:A53.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT

Related Links

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http://www.williamslifeskills.com/

website about Williams LifeSkills

Other Identifiers

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R42HL072644-02A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

497

Identifier Type: -

Identifier Source: org_study_id

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