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

NCT04984681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-01

Study results available
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Summary

In our Supplement Aim we will conduct a two-arm randomized pilot test of the adapted intervention compared to a usual care control group among 30 African American/Black women with HIV (15/arm) to assess the feasibility and acceptability of the mindfulness-based stress reduction among women with HIV with mild cognitive impairment. Feasibility will be assessed by our ability to (1) recruit, randomize, and retain participants and (2) deliver the intervention per the manual, as well as (3) participants adherence to home practices and assignments. Acceptability will be assessed via qualitative data (focus group input regarding participants' satisfaction with the intervention and intent to continue using the practices), as well quantitative data (satisfaction survey).

Conditions

Interventions

BEHAVIORAL

Mindfulness

The traditional mindfulness intervention consists of the following: (1) orientation; (2) a series of eight weekly session of 2.5 to 3 hours; (3) a silent retreat during the between weeks 4 and 6; (4) daily home assignments including formal and informal mindfulness practices; and (5) didactic presentations on stress and the consequences of stress.

OTHER

Usual Care

The control condition will continue receiving usual care or standard of care.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2022-11-10
Completion
2022-12-14

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04984681 on ClinicalTrials.gov