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

Study Overview
=================
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.

Official Title
-----------------
Impact of LifeSkills Training on Blood Pressure in Youth

Conditions
-----------------
Cardiovascular Diseases, Hypertension

Intervention / Treatment
-----------------
* Behavioral: Williams LifeSkills Stress and Anger Management Workshop
* Behavioral: High school classes


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* Williams LifeSkills Stress and Anger Management Workshop<br>|
| Placebo Comparator: 2<br>Control group (will attend regular high school classes) | Behavioral: High school classes<br>* The control group will attend regular high school classes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Pressure, Systolic Blood Pressure, Diastolic Blood Pressure, Ambulatory Blood Pressure Monitoring, Relaxation, Meditation, Coping Skills, Adolescents