Mindfulness-based Stress Reduction for Urban Youth

Stress, Psychological Clinical Trial

Official title:

Mindfulness-based Stress Reduction for Urban Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661271
• Other study ID #: NA_00002064
• Secondary ID: R21AT005209
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: March 2012

Study information

• Verified date: May 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

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.
• Healthy topics
8 week health education program with one retreat session

Locations

Country	Name	City	State
United States	Johns Hopkins, Harriet Lane Clinic	Baltimore	Maryland
United States	Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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