Mindfulness-based Stress Reduction for Urban Youth

NCT ID: NCT00661271

Last Updated: 2018-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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A randomized controlled trial will be conducted at two urban clinic sites. HIV-positive youth between the ages of 14 and 22 will be recruited and randomized into either an eight-week (with one retreat session) Mindfulness-Based Stress Reduction (MBSR) course (intervention) or an eight-week (with one retreat session) Healthy Topics (HT) course (active control). Measures of psychological functioning, coping, and life satisfaction will take place at baseline, immediately post-program, and 3-months post program. Medical data, including Cluster of Differentiation 4 (CD4) and viral load counts, will also be collected at the three data collection time points.

Conditions

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Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mindfulness-Based Stress Reduction

8-week mindfulness-based stress reduction program with one retreat session

Group Type EXPERIMENTAL

Mindfulness-based stress reduction (MBSR)

Intervention Type BEHAVIORAL

8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session.

Healthy Topics

8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill

Group Type ACTIVE_COMPARATOR

Healthy topics

Intervention Type BEHAVIORAL

8 week health education program with one retreat session

Interventions

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Mindfulness-based stress reduction (MBSR)

8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session.

Intervention Type BEHAVIORAL

Healthy topics

8 week health education program with one retreat session

Intervention Type BEHAVIORAL

Other Intervention Names

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MBSR

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erica M Sibinga, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Johns Hopkins, Harriet Lane Clinic

Baltimore, Maryland, United States

Site Status

Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Webb L, Perry-Parrish C, Ellen J, Sibinga E. Mindfulness instruction for HIV-infected youth: a randomized controlled trial. AIDS Care. 2018 Jun;30(6):688-695. doi: 10.1080/09540121.2017.1394434. Epub 2017 Oct 25.

Reference Type RESULT
PMID: 29067834 (View on PubMed)

Sibinga EM, Perry-Parrish C, Thorpe K, Mika M, Ellen JM. A small mixed-method RCT of mindfulness instruction for urban youth. Explore (NY). 2014 May-Jun;10(3):180-6. doi: 10.1016/j.explore.2014.02.006. Epub 2014 Feb 25.

Reference Type DERIVED
PMID: 24767265 (View on PubMed)

Other Identifiers

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R21AT005209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00002064

Identifier Type: -

Identifier Source: org_study_id

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