Cardiovascular DiseasesPhase 2NCT00508612
Effectiveness of an Anger and Stress Management Program on Reducing Blood Pressure Levels in Youth
A Phase 2 study testing Williams LifeSkills Stress and Anger Management Workshop and High school classes in people with Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI) at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension
- What is being tested?
- Williams LifeSkills Stress and Anger Management Workshop and High school classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2007to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school student
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Richmond County Board of Education Public Schools
Augusta, Georgia, 30901
Medical College of Georgia - Georgia Prevention Institute
Augusta, Georgia, 30912
Williams LifeSkills
Durham, North Carolina, 27705
About this study
Official title: Impact of LifeSkills Training on Blood Pressure in Youth
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Hypertension
- Being tested
- Williams LifeSkills Stress and Anger Management Workshop, High school classes
- Keywords
- Blood Pressure, Systolic Blood Pressure, Diastolic Blood Pressure, Ambulatory Blood Pressure Monitoring, Relaxation, Meditation, Coping Skills, Adolescents
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Williams LifeSkills Stress and Anger Management WorkshopBehavioural
Williams LifeSkills Stress and Anger Management Workshop
High school classesBehavioural
The control group will attend regular high school classes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Williams LifeSkills Stress and Anger Management Workshop |
| 2 | Placebo comparator | Control group (will attend regular high school classes) Receives: Behavioral: High school classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in day-time ambulatory systolic blood pressure
Measured: Measured at post-intervention after the 12 lesson program and at 3- and 6-month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Williams LifeSkills
- Responsible party
- Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Vernon A. Barnes, PhD, Principal investigator, Medical College of Georgia - Georgia Prevention InstituteVirginia P. Williams, PhD, Principal investigator, Williams LifeSkills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508612
- Sponsor's protocol ID
- 497
- Other IDs
- R42HL072644-02A2
- Status last verified
- Mar 2013
- First submitted
- 27 Jul 2007
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of LifeSkills Training on Blood Pressure in Youth
- ClinicalTrials.gov ID
- NCT00508612
- Acronym / sponsor ID
- 497
- Conditions
- Cardiovascular Diseases, Hypertension
- Keywords
- Blood Pressure, Systolic Blood Pressure, Diastolic Blood Pressure, Ambulatory Blood Pressure Monitoring, Relaxation, Meditation, Coping Skills, Adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Williams LifeSkills
- Study start
- Apr 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Williams LifeSkills Stress and Anger Management WorkshopThe 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. |
| 2 | Placebo comparator | Behavioral: High school classesControl group (will attend regular high school classes) |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- High school student
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Williams LifeSkills Stress and Anger Management WorkshopWilliams LifeSkills Stress and Anger Management Workshop | Behavioural | 1 |
| High school classesThe control group will attend regular high school classes. | Behavioural | 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Results publicationBarnes VA, Williams VP, Williams RB. Impact of Williams LifeSkills training on blood pressure in adolescents. Psychosomatic Medicine. 2005;67:A78.
- Results publicationBarnes VA, Williams VP, Williams RB. Effects of Williams LifeSkills training on anger reduction in African American adolescents. Psychosomatic Medicine. 2005;67:A53.
- Results publicationBarnes 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.
- Results publicationBarnes 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.
- Results publicationBarnes 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.
- website about Williams LifeSkillsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vernon A. Barnes, PhD principal investigator
Medical College of Georgia - Georgia Prevention Institute
Virginia P. Williams, PhD principal investigator
Williams LifeSkills
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Williams LifeSkills Stress and Anger Management Workshop and High school classes in people with Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508612, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.