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Mindfulness Based Stress Reduction for High Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title MBSR Progressive Muscle Relaxation Total
Hide 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
Hide 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
1.Primary Outcome
Title SBP
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
56 participatns intent to treat
Arm/Group Title MBSR Progressive Muscle Relaxation
Hide 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
Hide Description Clinic BP
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBSR Progressive Muscle Relaxation
Hide 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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MBSR Progressive Muscle Relaxation
Hide 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   --/--   --/-- 
Hide Serious Adverse Events
MBSR Progressive Muscle Relaxation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Hide 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%) 
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
Layout table for Results Point of Contact information
Name/Title: Joel Hughes
Organization: Kent State University
Phone: 330-672-7721
EMail: jhughes1@kent.edu
Layout table for additonal information
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