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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00661271
Other study ID # NA_00002064
Secondary ID R21AT005209
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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