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

This study has been completed.
Sponsor:
Collaborator:
Williams LifeSkills
Information provided by (Responsible Party):
Vernon Barnes, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00508612
First received: July 27, 2007
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Cardiovascular Diseases
Hypertension
Behavioral: Williams LifeSkills Stress and Anger Management Workshop
Behavioral: High school classes
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Impact of LifeSkills Training on Blood Pressure in Youth

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 259
Study Start Date: April 2007
Study Completion Date: March 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508612

Locations
United States, Georgia
Medical College of Georgia - Georgia Prevention Institute
Augusta, Georgia, United States, 30912
Richmond County Board of Education Public Schools
Augusta, Georgia, United States, 30901
United States, North Carolina
Williams LifeSkills
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Williams LifeSkills
Investigators
Principal Investigator: Vernon A. Barnes, PhD Medical College of Georgia - Georgia Prevention Institute
Principal Investigator: Virginia P. Williams, PhD Williams LifeSkills
  More Information

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

Responsible Party: Vernon Barnes, Assistant Professor, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00508612     History of Changes
Other Study ID Numbers: 497, R42 HL072644-02A2
Study First Received: July 27, 2007
Last Updated: March 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Blood Pressure
Systolic Blood Pressure
Diastolic Blood Pressure
Ambulatory Blood Pressure Monitoring
Relaxation
Meditation
Coping Skills
Adolescents

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014