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Clinical Trials/NCT04984681
NCT04984681
Completed
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country30 target enrollmentMarch 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
University of Alabama at Birmingham
Enrollment
30
Locations
1
Primary Endpoint
Feasibility of the Mindfulness Intervention in Women With Mild Cognitive Impairment
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2, 2022
End Date
December 14, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Crystal C. Lambert

Associate Professor

University of Alabama at Birmingham

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Feasibility of the Mindfulness Intervention in Women With Mild Cognitive Impairment

Time Frame: 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.

Study Sites (1)

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