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A Mindfulness Based Approach to HIV Treatment Side Effects

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ClinicalTrials.gov Identifier: NCT00312936
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Mindfulness-based Stress Reduction (MBSR) Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Mindfulness Based Approach to HIV Treatment Side Effects
Study Start Date : July 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Wait List
Experimental: MBSR
8 week mindfulness based stress reduction
 Behavioral: Mindfulness-based Stress Reduction (MBSR)
8 week program


Outcome Measures
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Primary Outcome Measures :
  1. Patient reported number and severity of ART side effects [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Health related quality of life [ Time Frame: 6 months ]
  2. ART adherence [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV+ serostatus, evidenced by letter from provider, or official HIV test results.
  2. Currently (prior 30 days) on an acknowledged ART regimen.
  3. 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
  4. Ability to provide informed consent to be a research participant.
  5. English speaking.

Exclusion Criteria:

  1. 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.
  2. Severe cognitive impairment as assessed by trained interviewer and confirmed by PI;
  3. Active psychosis as assessed by trained interviewer and confirmed by PI;

  4. Indication of active substance abuse that would interfere with capacity to participate in MBSR.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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 )
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 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