Phase 2
Completed N=177
Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV
Source: ClinicalTrials.gov NCT00271856 ↗Enrolled (actual)
177
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Change in CD4 T-cell Count — -57.1; -70.3 cells/µl
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.
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 |
— | — |
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.
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. Informational only — not medical advice.