Hypertension
Conditions
Brief summary
Nearly 60 million adults in the United States have high blood pressure (BP) in the pre-hypertension (SBP 120-139 or DBP 80-89). Hypertension is estimated to account for 1 in 8 deaths in the world, and in the US the direct and indirect costs of high BP are estimated to reach $59.7 billion in 2005. JNC-7 guidelines recommend lifestyle modifications for prehypertension, followed by antihypertensive medication if BP progresses to Stage I hypertension. Mindfulness-based Stress Reduction (MBSR) is an increasingly popular practice that has been purported to alleviate stress and treat certain health conditions. Some stress management therapies and one meditation therapy (e.g., Transcendental Meditation) have shown promise in reducing elevated BP, but MBSR has not been evaluated as a treatment for high BP. When added to lifestyle modification advice, MBSR may be an appropriate complementary treatment for prehypertension. However, prior to a large randomized clinical trial of MBSR for prehypertension and/or hypertension, pilot data is necessary to provide preliminary evidence of a treatment effect and to evaluate feasibility. This feasibility randomized clinical trial of MBSR for unmedicated prehypertension will provide preliminary evidence to support a larger randomized clinical trial by evaluating the feasibility and safety of MBSR as a complementary treatment for high BP and by documenting any treatment effect. Sixty patients with unmedicated BP in the range of SBP 120-139 mm Hg or DBP 80-89 mm Hg will be randomly assigned to MBSR or a progressive muscle relaxation control condition. All patients will receive lifestyle modification advice. Patients will complete 8 weeks of MBSR delivered in a group format by an experienced psychologist trained in MBSR or 8 weeks of progressive muscle relaxation training matched for therapist contact and homework. Patients BP will be assessed prior to randomization and following treatment by researchers blind to treatment assignment. Accrual rates, acceptance of randomization, treatment adherence, treatment fidelity, and patient satisfaction with treatment will be evaluated.
Detailed description
See brief summary
Interventions
8 weeks group MBSR
8 weeks PMR in group format
Sponsors
Study design
Eligibility
Inclusion criteria
* prehypertension * 30-60 years of age
Exclusion criteria
* normal BP * hypertension * pregnancy * smoking * use of antihypertensive medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SBP | 12 weeks | — |
| DBP | 12 weeks | Clinic BP |
Countries
United States
Participant flow
Recruitment details
248 Assessed for eligibility 192 excluded
Pre-assignment details
181 did not meet inclusion criteria 11 did not consent to participate
Participants by arm
| Arm | Count |
|---|---|
| MBSR Mindfulness based stress reduction | 28 |
| Progressive Muscle Relaxation Progressive Muscle Relaxation 8 weeks group treatment | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Progressive Muscle Relaxation | MBSR | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 28 Participants | 56 Participants |
| Age, Continuous | 49.5 years STANDARD_DEVIATION 7.2 | 51.2 years STANDARD_DEVIATION 5.8 | 50.3 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 32 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
DBP
Clinic BP
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBSR | DBP | 77.3 mm Hg | Standard Deviation 4.8 |
| Progressive Muscle Relaxation | DBP | 78.3 mm Hg | Standard Deviation 6.1 |
SBP
Time frame: 12 weeks
Population: 56 participatns intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBSR | SBP | 130.2 mm Hg | Standard Deviation 6.3 |
| Progressive Muscle Relaxation | SBP | 128.8 mm Hg | Standard Deviation 6.3 |