Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312936
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2006-04-07
Brief Title:
A Mindfulness Based Approach to HIV Treatment Side Effects
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Mindfulness Based Approach to HIV Treatment Side Effects
Status:
COMPLETED
Status Verified Date:
2016-05
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:
We are exploring the effect that an 8 week stress reduction program based in mindfulness practices will have on the experience of medication side effects reported by HIV-infected men and women taking antiretroviral therapy
Detailed Description:
As HIV treatments continue to advance people living with HIV will inevitably be confronted with negative physical and emotional side effects Side effects from antiretroviral therapy ART for HIV impact quality of life QOL and adherence to care and they influence decisions about health care With mortality rates from HIV dramatically reduced in the US side effects emerge as one of the most critical factors in the HIV epidemic Eliminating or reducing the negative impact of side effects may improve QOL reduce missed days from work and maximize benefit from treatment for people living with HIV We propose a randomized controlled trial RCT to provide preliminary evidence of the efficacy of a Mindfulness-Based Stress Reduction MBSR intervention to remediate side effects and side effect-related distress Decreases in medical and psychological symptoms have been observed following MBSR in a wide range of illness contexts but the approach has not been applied to HIV treatment side effects Our team brings together expertise in HIV treatment side effects research MBSR research with HIV populations and HIV clinical medicine The proposed study maximizes resources from our funded research programs within one of the leading AIDS research institutions in the world Relevant research entities supporting this proposal include the Center for AIDS Prevention Studies CAPS the Osher Center for Integrative Medicine OCIM the UCSF Center for AIDS Research CFAR and the UCSF AIDS Research Institute ARI We propose a randomized clinical trial of an 8-week program of MBSR with 100 HIV men and women on ART as compared with a wait list control n50group Primary outcome will be side effect distress and frequency and secondary outcomes will be QOL and medication adherence The findings from this study in conjunction with our ongoing research studies will provide foundation and guidance including effect size data for larger studies of MBSR for HIV disease
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 |
|---|---|---|---|
| R21AT003102-01 | NIH | None | httpsreporternihgovquickSearchR21AT003102-01 |