Mindfulness Based Stress Reduction for High Blood Pressure

• ClinicalTrials.gov Identifier: NCT00440596
• Recruitment Status: Completed
• First Posted: February 27, 2007
• Results First Posted: November 9, 2020
• Last Update Posted: November 9, 2020
• Sponsor: Kent State University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Joel Hughes, Kent State University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hypertension
• Interventions: Behavioral: Mindfulness based stress reduction; Behavioral: Progressive Muscle Relaxation
• Enrollment: 56

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

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 Number of Baseline Participants		28	28	56
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	28 participants	56 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	28 100.0%	28 100.0%	56 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	28 participants	28 participants	56 participants
		51.2 (5.8)	49.5 (7.2)	50.3 (7.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	28 participants	56 participants
	Female	17 60.7%	15 53.6%	32 57.1%
	Male	11 39.3%	13 46.4%	24 42.9%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	28 participants	28 participants	56 participants
		28	28	56

Outcome Measures

1. Primary Outcome

Title	SBP
Description	[Not Specified]
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:	[Not Specified]	[Not Specified]
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: 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
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: mm Hg
	77.3 (4.8)	78.3 (6.1)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
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 (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	MBSR	Progressive Muscle Relaxation
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/28 (0.00%)	0/28 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	MBSR	Progressive Muscle Relaxation
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/28 (0.00%)	0/28 (0.00%)

Limitations and 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.

Results Point of Contact

• Name/Title: Joel Hughes
• Organization: Kent State University
• Phone: 330-672-7721
• EMail: jhughes1@kent.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hughes JW, Fresco DM, Myerscough R, van Dulmen MH, Carlson LE, Josephson R. Randomized controlled trial of mindfulness-based stress reduction for prehypertension. Psychosom Med. 2013 Oct;75(8):721-8. doi: 10.1097/PSY.0b013e3182a3e4e5.

• Responsible Party: Joel Hughes, Kent State University
• ClinicalTrials.gov Identifier: NCT00440596
• Other Study ID Numbers: R21AT002698-01A2 ( U.S. NIH Grant/Contract )
• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Results First Submitted: June 22, 2011
• Results First Posted: November 9, 2020
• Last Update Posted: November 9, 2020