Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 7, 2006
March 19, 2013
July 2006
October 2008   (final data collection date for primary outcome measure)
Patient reported number and severity of ART side effects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patient reported number and severity of ART side effects
Complete list of historical versions of study NCT00312936 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Health related quality of life
  • ART adherence
Not Provided
Not Provided
 
A Mindfulness Based Approach to HIV Treatment Side Effects
A Mindfulness Based Approach to HIV Treatment Side Effects

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
HIV Infections
Behavioral: Mindfulness-based Stress Reduction (MBSR)
8 week program
  • No Intervention: Wait List
  • Experimental: MBSR
    8 week mindfulness based stress reduction
    Intervention: Behavioral: Mindfulness-based Stress Reduction (MBSR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
October 2008
October 2008   (final data collection date for primary outcome measure)

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.

    -

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00312936
R21 AT003102-01, R21AT003102-01
Yes
University of California, San Francisco
University of California, San Francisco
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Mallory O Johnson, PhD University of California, San Francisco
University of California, San Francisco
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP