NCT00508612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for phase_2 cardiovascular-diseases

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 12, 2016

Status Verified

March 1, 2013

Enrollment Period

2.1 years

First QC Date

July 27, 2007

Last Update Submit

July 11, 2016

Conditions

Cardiovascular DiseasesHypertension

Keywords

Blood PressureSystolic Blood PressureDiastolic Blood PressureAmbulatory Blood Pressure MonitoringRelaxationMeditationCoping SkillsAdolescents

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

Control group (will attend regular high school classes)

Behavioral: High school classes

Interventions

Williams LifeSkills Stress and Anger Management WorkshopBEHAVIORAL

Williams LifeSkills Stress and Anger Management Workshop

1
High school classesBEHAVIORAL

The control group will attend regular high school classes.

2

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High school student

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Richmond County Board of Education Public Schools

Augusta, Georgia, 30901, United States

Location

Medical College of Georgia - Georgia Prevention Institute

Augusta, Georgia, 30912, United States

Location

Williams LifeSkills

Durham, North Carolina, 27705, United States

Location

Related Publications (5)

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

    RESULT

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

    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.

    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.

    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.

    RESULT

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesHypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Vernon A. Barnes, PhD

    Medical College of Georgia - Georgia Prevention Institute

    PRINCIPAL INVESTIGATOR

  • Virginia P. Williams, PhD

    Williams LifeSkills

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 30, 2007

Study Start

April 1, 2007

Primary Completion

May 1, 2009

Study Completion

March 1, 2010

Last Updated

July 12, 2016

Record last verified: 2013-03

Locations

US(3)