Mindfulness-based Stress Reduction for Urban Youth

Study Overview
=================
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.

Official Title
-----------------
Mindfulness-based Stress Reduction for Urban Youth

Conditions
-----------------
Stress, Psychological

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based stress reduction (MBSR)
* Behavioral: Healthy topics


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction<br>8-week mindfulness-based stress reduction program with one retreat session | Behavioral: Mindfulness-based stress reduction (MBSR)<br>* 8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session.<br>* Other names: MBSR;|
| Active Comparator: Healthy Topics<br>8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill | Behavioral: Healthy topics<br>* 8 week health education program with one retreat session<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mindful Attention and Awareness Scale (MAAS) | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mindfulness, meditation, urban youth, stress reduction, adolescent, Stress reduction for urban youth