A Mindfulness Based Approach to HIV Treatment Side Effects

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00312936
First received: April 7, 2006
Last updated: March 19, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • ART adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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.

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  Contacts and Locations
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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
Investigators
Principal Investigator: Mallory O Johnson, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00312936     History of Changes
Other Study ID Numbers: R21 AT003102-01, R21AT003102-01
Study First Received: April 7, 2006
Last Updated: March 19, 2013
Health Authority: United States: Federal Government

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
Acquired Immunodeficiency Syndrome
Iatrogenic Disease
Drug-Related Side Effects and Adverse Reactions
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 27, 2014