Trial Outcomes & Findings for Mindfulness Based Stress Reduction for High Blood Pressure (NCT NCT00440596)

NCT ID: NCT00440596

Last Updated: 2020-11-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-11-09

Participant Flow

248 Assessed for eligibility 192 excluded

181 did not meet inclusion criteria 11 did not consent to participate

Participant milestones

Measure	MBSR Mindfulness based stress reduction	Progressive Muscle Relaxation Progressive Muscle Relaxation 8 weeks group treatment
Overall Study STARTED	28	28
Overall Study COMPLETED	21	17
Overall Study NOT COMPLETED	7	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness Based Stress Reduction for High Blood Pressure

Baseline characteristics by cohort

Measure	MBSR n=28 Participants Mindfulness based stress reduction	Progressive Muscle Relaxation n=28 Participants Progressive Muscle Relaxation 8 weeks group treatment	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51.2 years STANDARD_DEVIATION 5.8 • n=5 Participants	49.5 years STANDARD_DEVIATION 7.2 • n=7 Participants	50.3 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 56 participatns intent to treat

Outcome measures

Measure	MBSR n=28 Participants	Progressive Muscle Relaxation n=28 Participants
SBP	130.2 mm Hg Standard Deviation 6.3	128.8 mm Hg Standard Deviation 6.3

PRIMARY outcome

Timeframe: 12 weeks

Clinic BP

Outcome measures

Measure	MBSR n=28 Participants	Progressive Muscle Relaxation n=28 Participants
DBP	77.3 mm Hg Standard Deviation 4.8	78.3 mm Hg Standard Deviation 6.1

Adverse Events

MBSR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Progressive Muscle Relaxation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joel Hughes

Kent State University

Phone: 330-672-7721

Email: jhughes1@kent.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place