Mindfulness-based Stress Reduction for Urban Youth

May 31, 2018 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins, Harriet Lane Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Stress Reduction
8-week mindfulness-based stress reduction program with one retreat session
Behavioral: 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.
Other Names:
  • MBSR
Active Comparator: Healthy Topics
8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill
Behavioral: Healthy topics
8 week health education program with one retreat session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindful Attention and Awareness Scale (MAAS)
Time Frame: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
  • Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness
  • Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism
  • Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior
assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
Life satisfaction was measured with the HIV Quality of Life (QOL) measure, which included three subscales: life satisfaction (range: 1-5), illness burden (range: 1-5) and illness anxiety (range: 1-5). For life satisfaction, higher scores indicated higher satisfaction, and for the other two subscales greater scores indicated more issues with illness burden and illness anxiety.
assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Erica M Sibinga, MD, MHS, Johns Hopkins School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00002064
  • R21AT005209 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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