Mindfulness-based Stress Reduction for Urban Youth

Not Applicable

Completed

• Conditions: Stress, Psychological
• Interventions: Behavioral: Mindfulness-based stress reduction (MBSR); Behavioral: Healthy topics

• Registration Number: NCT00661271
• Lead Sponsor: Johns Hopkins University

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.

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-18
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2015-07-07
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-31
• Last Update Submitted: 2018-05-31
• Results First Posted: 2018-06-28
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Stress Reduction	Mindfulness-based stress reduction (MBSR)	8-week mindfulness-based stress reduction program with one retreat session
Healthy Topics	Healthy topics	8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill

Primary Outcome Measures

Name	Time	Method
Mindful Attention and Awareness Scale (MAAS)	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

Secondary Outcome Measures

Name	Time	Method
Quality of Life	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.

Trial Locations

Locations (2)

Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic; 🇺🇸 Philadelphia, Pennsylvania, United States

Johns Hopkins, Harriet Lane Clinic; 🇺🇸 Baltimore, Maryland, United States