A Mindfulness Based Approach to HIV Treatment Side Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mindfulness Meditation Training in HIV

NCT00600561

HIV Infections

COMPLETED PHASE2

Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV

NCT00271856

HIV

COMPLETED PHASE2

A Randomized Controlled Trial of a Mindfulness-Based Stress Reduction Intervention for Men Living With HIV

NCT00529971

HIV Infections

COMPLETED PHASE3

Health Improvement for Baltimore Youth

NCT02624193

HIV Adolescent Development Adolescent Behavior +1 more

COMPLETED NA

Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV

NCT04193605

HIV Infections Health Behavior

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wait List

Group Type NO_INTERVENTION

No interventions assigned to this group

MBSR

8 week mindfulness based stress reduction

Group Type EXPERIMENTAL

Mindfulness-based Stress Reduction (MBSR)

Intervention Type BEHAVIORAL

8 week program

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness-based Stress Reduction (MBSR)

8 week program

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No