This phase 3 trial will evaluate if managing stress can reduce blood pressure in patients with hypertension. The main outcome to be investigated is a reduction in blood pressure. This trial is being conducted in Cleveland, Ohio and Philadelphia, Pennsylvania.
The details
Managing hypertension (high blood pressure) involves several strategies. In addition to prescribing blood pressure medications, patients may also benefit from lifestyle changes. Stress has been shown to elevate blood pressure and managing stress is important for patients with hypertension.
This trial will evaluate the effectiveness of stress management strategies on blood pressure levels. Effectiveness will be measured as a reduction in blood pressure.
Who are they looking for?
This trial will recruit 180 patients with hypertension (aged 21 to 70). Participants must have blood pressure levels between 120/80 and 139/89 and a body mass index (BMI) between 19 and 40. Patients cannot be taking medication to control blood pressure.
Patients cannot participate in the trial if they have uncontrolled hypertension or a pacemaker. Other exclusion criteria include: history of heart attack, atrial fibrillation, heart failure or coronary bypass surgery (in last 6 months), smoking, excessive alcohol consumption, chronic kidney disease and pregnant/breastfeeding women.
How will it work
Participants will be randomly assigned to 3 groups. One group will undergo mindfulness-based stress reduction and another group will undergo stress management education. Both of these strategies involve 8 group sessions (2.5 hour duration) per week and 1 all-day retreat. The third group will receive standard education from the American Heart Association on self-care for hypertension. The trial will last 60 weeks. Each patient will be required to attend clinic visits at week 0, 4, 8, 34 and 60 for blood pressure measurement.
The main outcome to be measured is the change in blood pressure levels.
