Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00271856
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
2005-12-30
Brief Title:
Staying Well A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Mindfulness-Based Stress Reduction MBSR Stress Arousal and Immune Response in Early HIV
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Stress and depression are associated with more rapid loss of CD4 cells in HIV infection Interventions that slow the advance of HIV infection and delay the introduction of antiretroviral therapy ART could make an important contribution to HIV management in both the developed and developing world We are conducting a 330 person randomized controlled clinical trial of MBSR for persons with HIV-1 infection and CD4 T-lymphocyte counts 250 cellsµm who are not on antiretroviral therapy Participants are randomized in a 11 distribution to either the MBSR intervention or to an education group that will control for the attention and social interaction aspects of MBSR Participants are evaluated at 0 3 6 and 12 months Key outcome measures at 12 months include differences in CD4 T cell counts HIV viral load perceived stress depression and positive affect We are also examining whether MBSR is associated with changes in neuroendocrine function autonomic nervous system activity cortisol secretion and alterations in immune function that may serve as intermediate steps between the neuroendocrine effects of MBSR and CD4 T cell counts such as changes in T cell activation A subset of 90 participants will be studied in additional detail using a structured laboratory stress challenge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01AT002024 | NIH | None | httpsreporternihgovquickSearchP01AT002024 |