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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Mindfulness-based Stress Reduction (MBSR)

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94105
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait List
Experimental: MBSR; 8 week mindfulness based stress reduction	Behavioral: Mindfulness-based Stress Reduction (MBSR); 8 week program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient reported number and severity of ART side effects	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Health related quality of life	6 months
ART adherence	6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Mallory O Johnson, PhD, University of California, San Francisco

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: April 7, 2006
• First Submitted That Met QC Criteria: April 7, 2006
• First Posted (Estimate): April 11, 2006

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Quality of Life; Medication adherence; treatment experienced; HIV/AIDS; Stress reduction; mindfulness based stress reduction; Medication compliance
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: R21AT003102-01 (U.S. NIH Grant/Contract)