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Mindfulness-based Stress Reduction for Urban Youth

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ClinicalTrials.gov Identifier: NCT00661271
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : July 19, 2012
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Erica Sibinga, Johns Hopkins University

Study Description
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Brief Summary:
Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests benefits in mental health and quality of life outcomes. To evaluate further the specific effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program compared with a health education program.

Condition or disease Intervention/treatment Phase
Stress Reduction Behavioral: Mindfulness-based stress reduction (MBSR) Behavioral: Healthy topics Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness-based Stress Reduction for Urban Youth
Study Start Date : September 2007
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: A
8 week mindfulness-based stress reduction program
 Behavioral: Mindfulness-based stress reduction (MBSR)
8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice.
Other Name: MBSR
Active Comparator: B
Health education group--8 weekly sessions of age-appropriate health topics.
 Behavioral: Healthy topics
8 week health education program


Outcome Measures
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Primary Outcome Measures :
  1. mental health outcomes [ Time Frame: post group ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: post group ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 14-22 year old youth who receive primary care at the Harriet Lane Clinic or Children's Hospital of Philadelphia.

Exclusion Criteria:

  • Significant developmental, behavioral, substance abuse, or psychiatric disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661271


Locations
United States, Maryland
Johns Hopkins, Harriet Lane Clinic
Baltimore, Maryland, United States, 21287
United States, Pennsylvania
Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Johns Hopkins University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Erica M Sibinga, MD, MHS Johns Hopkins School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Erica Sibinga, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00661271     History of Changes
Other Study ID Numbers: NA_00002064
R21AT005209 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: July 19, 2012
Last Verified: March 2011

Keywords provided by Erica Sibinga, Johns Hopkins University:
mindfulness
meditation
urban youth
 stress reduction
adolescent
Stress reduction for urban youth