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

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

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 Overview

• Status: Completed
• Conditions: HIV Infections; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Mindfulness; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based Stress Reduction; Mindfulness-based stress reduction sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.	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.	Other: Usual Care; The control condition will continue receiving usual care or standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Mindfulness Intervention in Women With Mild Cognitive Impairment	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	Adherence will be measured by the single-item antiretroviral therapy question. Higher scores indicate better antiretroviral therapy adherence.	Immediately post-intervention
Perceived Stress	Perceived stress will be measures using the perceived stress scale (PSS), with higher scores indicating higher perceived stress.	Immediately post-intervention
Mental Distress	Mood will be assessed using the PHQ-8. Higher scores are indicate increased symptom severity.	immediately post-intervention

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: HIV; Mindfulness; Cisgender women; African American or Black
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: K23AT010567S; K23AT010567 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The University of Alabama at Birmingham maintains the following universal data sharing policy for all investigators:

1. Data will be made available, in accordance with the NIH Data Sharing Policy (http://grants.nih.gov/grants/policy/data_sharing) to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. In some cases the institution may determine that the public and the research community are better served by a licensing program whether or not patents have been filed. This may be relevant, for example, if a tool is best distributed under license to guarantee reagent availability and quality.
2. As a means of sharing knowledge, NIH encourages grantees to arrange for publication of NIH-supported original research in primary scientific journals. We therefore will strive to publish our findings in a timely manner and acknowledge that the research was supported by the NIH.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No