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| Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00312936 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Mindfulness-based Stress Reduction (MBSR) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | A Mindfulness Based Approach to HIV Treatment Side Effects |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Wait List: No Intervention | |
|
MBSR: Experimental
8 week mindfulness based stress reduction
|
Behavioral: Mindfulness-based Stress Reduction (MBSR)
8 week program
|
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 (n=50/group). 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Indication of active substance abuse that would interfere with capacity to participate in MBSR.
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Contacts and Locations| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94105 | |
| Principal Investigator: | Mallory O Johnson, PhD | University of California, San Francisco |
More Information
| Responsible Party: | UCSF ( Mallory Johnson ) |
| Study ID Numbers: | R21 AT003102-01, R21 AT003102-01 |
| Study First Received: | April 7, 2006 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00312936 |
| Health Authority: | United States: Federal Government |
|
Medication adherence Medication compliance Quality of Life Stress reduction |
mindfulness based stress reduction HIV/AIDS treatment experienced |
|
Virus Diseases Sexually Transmitted Diseases, Viral Iatrogenic Disease HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Quality of Life Stress Retroviridae Infections Immunologic Deficiency Syndromes |
|
Disease Attributes RNA Virus Infections Pathologic Processes Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |
