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A Mindfulness Based Approach to HIV Treatment Side Effects
This study has been completed.
Sponsor:
University of California, San Francisco
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00312936
First received: April 7, 2006
Last updated: May 12, 2016
Last verified: May 2016
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Mindfulness Based Approach to HIV Treatment Side Effects |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Patient reported number and severity of ART side effects [ Time Frame: 6 months ]
Secondary Outcome Measures:
- Health related quality of life [ Time Frame: 6 months ]
- ART adherence [ Time Frame: 6 months ]
| Enrollment: | 76 |
| Study Start Date: | July 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Wait List | |
|
Experimental: MBSR
8 week mindfulness based stress reduction
|
Behavioral: Mindfulness-based Stress Reduction (MBSR)
8 week program
|
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 (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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV+ serostatus, evidenced by letter from provider, or official HIV test results.
- Currently (prior 30 days) on an acknowledged ART regimen.
- Reporting a level of side effect-related bother for the previous 30 days at or above eight (corresponding to the 40th% in another sample) on the side effect and symptom distress scale used in other studies.1, 89
- Ability to provide informed consent to be a research participant.
- English speaking.
Exclusion Criteria:
- Current enrollment in a behavioral coping or HIV adherence intervention research study or MBSR program. A list of such studies/programs is kept and updated throughout the study.
- Severe cognitive impairment as assessed by trained interviewer and confirmed by PI;
- Active psychosis as assessed by trained interviewer and confirmed by PI;
-
Indication of active substance abuse that would interfere with capacity to participate in MBSR.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00312936
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312936
Locations
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94105 | |
Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Investigators
| Principal Investigator: | Mallory O Johnson, PhD | University of California, San Francisco |
More Information
Additional Information:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00312936 History of Changes |
| Other Study ID Numbers: |
R21AT003102-01 ( U.S. NIH Grant/Contract ) |
| Study First Received: | April 7, 2006 |
| Last Updated: | May 12, 2016 |
Keywords provided by University of California, San Francisco:
|
Medication adherence Medication compliance Quality of Life Stress reduction |
mindfulness based stress reduction HIV/AIDS treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on August 16, 2017