Phase 2 N=177 Randomized Treatment

Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV

HIV

Bottom Line

View on ClinicalTrials.gov: NCT00271856 ↗

Enrolled (actual)

177

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcome: Primary: Change in CD4 T-cell Count — -57.1; -70.3 cells/µl

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Mindfulness-Based Stress Reduction (MBSR) (Behavioral); HIV-education and self-management workshop (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in CD4 T-cell Count	-57.1; -70.3	—
PRIMARY Change in Depression as Measured by Beck Depression Inventory (BDI)	-1.85; -1.68	—
PRIMARY Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)	-0.58; -2.03	—
PRIMARY Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score	1.20; 1.64	—
PRIMARY Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score	-2.17; -2.63	—
PRIMARY Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)	-1.00; -1.46	—
SECONDARY Quality of Life (Short Form Health Survey; SF-36); Cortisol (Basal a.m. and Diurnal Change); T-cell Activation (i.e. CD38-cell Surface Marker) and NK Cell Number and Function; Autonomic Nervous System Activity ; Cell Aging	—	—

Summary

To examine the effects of Mindfulness-Based Stress Reduction (MBSR) and education groups on HIV (Human Immunodeficiency Syndrome) infection. Key outcomes include CD4 and viral load, stress hormones, depression and quality of life.

Eligibility Criteria

Inclusion Criteria

HIV+
Viral Load>100
CD4 T-Cells>250
Not on Antiretroviral therapy (ART)
Ability to Speak English
Stable address/living situation

Exclusion Criteria

Inability to provide informed consent
Use of ART within the past 120 days
Any substance abuse, mental health or medical condition that the opinion of the Principal Investigator (PI) would make it difficult for the potential participant to participate in the intervention
Plans to start ART in the next 12 months
Previous MBSR training and/or current practice
Current use or use in past 6 months (mos.) of chemotherapy or immunomodulator drugs, including oral steroids or plans to start in the next 12 mos.
Initiation of new class of psychiatric medication in past 2 months.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00271856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.