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

Hypertension Clinical Trial

Official title:

Impact of LifeSkills Training on Blood Pressure in Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508612
• Other study ID #: 497
• Secondary ID: R42HL072644-02A2
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2007
• Last updated: July 11, 2016
• Start date: April 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2013
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: March 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• Williams LifeSkills Stress and Anger Management Workshop
Williams LifeSkills Stress and Anger Management Workshop
• High school classes
The control group will attend regular high school classes.

Locations

Country	Name	City	State
United States	Medical College of Georgia - Georgia Prevention Institute	Augusta	Georgia
United States	Richmond County Board of Education Public Schools	Augusta	Georgia
United States	Williams LifeSkills	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)	Williams LifeSkills

Country where clinical trial is conducted

United States, 

References & Publications (5)

Barnes VA, Johnson MH, Williams RB, Williams VP. IMPACT OF WILLIAMS LIFESKILLS(®) TRAINING ON ANGER, ANXIETY AND AMBULATORY BLOOD PRESSURE IN ADOLESCENTS. Transl Behav Med. 2012 Dec 1;2(4):401-410. Epub 2012 Aug 30. — View Citation

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 M

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 Interdisciplina

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.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in day-time ambulatory systolic blood pressure		Measured at post-intervention after the 12 lesson program and at 3- and 6-month follow-up visits	No

External Links

•   website about Williams LifeSkills