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Clinical Trials/NCT04984681
NCT04984681CompletedNot 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 enrollmentStarted: March 2, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Feasibility of the Mindfulness Intervention in Women With Mild Cognitive Impairment

Study 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Mindfulness-based Stress Reduction

Experimental

Mindfulness-based stress reduction sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.

Intervention: Mindfulness (Behavioral)

Usual Care

Other

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

Intervention: Usual Care (Other)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Crystal C. Lambert

Associate Professor

University of Alabama at Birmingham

Study Sites (1)

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