A Mindfulness Based Approach to HIV Treatment Side Effects

HIV Infections Clinical Trial

Official title:

A Mindfulness Based Approach to HIV Treatment Side Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312936
• Other study ID #: R21AT003102-01
• Secondary ID: R21AT003102-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 7, 2006
• Last updated: May 12, 2016
• Start date: July 2006
• Est. completion date: October 2008

Study information

• Verified date: May 2016
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• HIV Infections
• Iatrogenic Disease

Intervention

Behavioral:
• Mindfulness-based Stress Reduction (MBSR)
8 week program

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported number and severity of ART side effects		6 months	No
Secondary	Health related quality of life		6 months	No
Secondary	ART adherence		6 months	No

External Links

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