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

Not Applicable

Completed

• Conditions: HIV Infections; Mild Cognitive Impairment

• Registration Number: NCT04984681
• Lead Sponsor: University of Alabama at Birmingham

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-30
• Study Start: 2022-03-02
• Primary Completion: 2022-11-10
• Study Completion: 2022-12-14
• Results First Submitted: 2023-12-13
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Results First Posted: 2024-09-30
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Cisgender females
• HIV seropositive
• 18 years of age or older
• English speaking
• An active patient at the local HIV ambulatory clinic in Alabama.
• No history of neurological (including dementia diagnosis)
• No history of severe psychiatric (e.g., schizophrenia or bipolar disorder) disorders

Exclusion Criteria

• Non-English speaking
• Appear temporarily impaired (e.g., intoxicated)
• Not willing to or legally unable to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of the Mindfulness Intervention in Women With Mild Cognitive Impairment	Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.	Feasibility was measured using a four-item feasibility of intervention measure. Each item is scored using a Likert-like scale ranging from "1" completely disagree to "5" completely agree. Higher scores indicate greater feasibility. The minimum total score is 4 points, and the maximum total score is 20.

Trial Locations

Locations (1)

UAB School of Nursing; 🇺🇸 Birmingham, Alabama, United States