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

NCT04984681 | Completed Results DMC

• 2 other identifiers: K23AT010567SK23AT010567
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections; Mild Cognitive Impairment

Keywords

HIV; Cisgender women; African American or Black; Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Behavioral: Mindfulness

Usual Care

OTHER

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

Other: Usual Care

Interventions

Mindfulness BEHAVIORAL

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.

Mindfulness-based Stress Reduction

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We are recruiting cisgender females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cisgender females
• HIV seropositive
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB School of Nursing

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

HIV Infections; Cognitive Dysfunction

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Crystal Chapman Lambert
• Organization: University of Alabama at Birmingham

cclamber@uab.edu

205-934-3481

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 30, 2021
• Study Start: March 2, 2022
• Primary Completion: November 10, 2022
• Study Completion: December 14, 2022
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)