Clinical trial NCT00508612: Effectiveness of an Anger and Stress Management Program on Reducing Blood Pressure Levels in Youth
Official title: Impact of LifeSkills Training on Blood Pressure in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Hypertension
Keywords: Blood Pressure
Systolic Blood Pressure
Diastolic Blood Pressure
Ambulatory Blood Pressure Monitoring
Relaxation
Meditation
Coping Skills
Adolescents
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
Collaborators: name: Williams LifeSkills
First posted: 2007-07-30
Enrollment: 259
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in day-time ambulatory systolic blood pressure
timeFrame: Measured at post-intervention after the 12 lesson program and at 3- and 6-month follow-up visits
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Richmond County Board of Education Public Schools
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia - Georgia Prevention Institute
state: Georgia
city: Durham
country: United States
facility: Williams LifeSkills
state: North Carolina
Study officials:
affiliation: Medical College of Georgia - Georgia Prevention Institute
name: Vernon A. Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Williams LifeSkills
name: Virginia P. Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes VA, Williams VP, Williams RB. Impact of Williams LifeSkills training on blood pressure in adolescents. Psychosomatic Medicine. 2005;67:A78.
citation: Barnes VA, Williams VP, Williams RB. Effects of Williams LifeSkills training on anger reduction in African American adolescents. Psychosomatic Medicine. 2005;67:A53.
citation: 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.
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 Meeting April 22-25, 2009; Montreal, Canada.
citation: 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.