Mindfulness Based Stress Reduction for High Blood Pressure

• Sponsor: Kent State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00440596
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: Mindfulness based stress reduction; Behavioral: Progressive Muscle Relaxation	N/A

Detailed Description

See brief summary

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mindfulness Based Stress Reduction for High Blood Pressure
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness based stress reduction Mindfulness based stress reduction	Behavioral: Mindfulness based stress reduction; 8 weeks group MBSR
Active Comparator: Progressive Muscle Relaxation Progressive Muscle Relaxation	Behavioral: Progressive Muscle Relaxation; 8 weeks PMR in group format

Outcome Measures

Primary Outcome Measures

1. SBP [12 weeks]

2. DBP [12 weeks]

   Clinic BP

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• prehypertension

• 30-60 years of age

Exclusion Criteria:

• normal BP

• hypertension

• pregnancy

• smoking

• use of antihypertensive medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Summa Health System	Akron	Ohio	United States	44304

Sponsors and Collaborators

• Kent State University
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Joel W Hughes, Ph.D., Kent State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joel Hughes, Professor, Kent State University
• ClinicalTrials.gov Identifier: NCT00440596
• Other Study ID Numbers: R21AT002698-01A2
• First Posted: Feb 27, 2007
• Last Update Posted: Nov 9, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Recruitment Details	248 Assessed for eligibility 192 excluded
Pre-assignment Detail	181 did not meet inclusion criteria 11 did not consent to participate

Arm/Group Title	MBSR	Progressive Muscle Relaxation
Arm/Group Description	Mindfulness based stress reduction	Progressive Muscle Relaxation 8 weeks group treatment
Period Title: Overall Study
STARTED	28	28
COMPLETED	21	17
NOT COMPLETED	7	11

Baseline Characteristics

Arm/Group Title	MBSR	Progressive Muscle Relaxation	Total
Arm/Group Description	Mindfulness based stress reduction	Progressive Muscle Relaxation 8 weeks group treatment	Total of all reporting groups
Overall Participants	28	28	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 100%	28 100%	56 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.2 (5.8)	49.5 (7.2)	50.3 (7.2)
Sex: Female, Male (Count of Participants)
Female	17 60.7%	15 53.6%	32 57.1%
Male	11 39.3%	13 46.4%	24 42.9%
Region of Enrollment (participants) [Number]
United States	28 100%	28 100%	56 100%

Outcome Measures

1. Primary Outcome

Title	SBP
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

56 participatns intent to treat

Arm/Group Title	MBSR	Progressive Muscle Relaxation
Arm/Group Description
Measure Participants	28	28
Mean (Standard Deviation) [mm Hg]	130.2 (6.3)	128.8 (6.3)

2. Primary Outcome

Title	DBP
Description	Clinic BP
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MBSR	Progressive Muscle Relaxation
Arm/Group Description	Mindfulness based stress reduction	Progressive Muscle Relaxation 8 weeks group treatment
Measure Participants	28	28
Mean (Standard Deviation) [mm Hg]	77.3 (4.8)	78.3 (6.1)

Adverse Events

Arm/Group Title	MBSR		Progressive Muscle Relaxation
Arm/Group Description	Mindfulness based stress reduction		Progressive Muscle Relaxation 8 weeks group treatment
All Cause Mortality
	MBSR		Progressive Muscle Relaxation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MBSR		Progressive Muscle Relaxation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	MBSR		Progressive Muscle Relaxation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.