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

Arm | Intervention/treatment |
---|---|
No Intervention: Wait List | |
Experimental: MBSR
8 week mindfulness based stress reduction
|
Behavioral: Mindfulness-based Stress Reduction (MBSR)
8 week program
|
- Patient reported number and severity of ART side effects [ Time Frame: 6 months ]
- Health related quality of life [ Time Frame: 6 months ]
- ART adherence [ Time Frame: 6 months ]

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

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
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 |
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 ) |
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 |