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

NCT04193605 | Completed Results DMC

• 1 other identifier: K23AT010567
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator propose to culturally adapt the mindfulness-based stress reduction (MSBR) intervention for Black/African American women living with HIV (WLWH) to reduce stress and enhance HIV self-care behaviors and viral load (VL) suppression, which has the potential to attenuate prominent racial and gender disparities experienced by Black WLWH in the US. Specifically, the investigator aims to 1) culturally adapt the MBSR intervention for Black WLWH using ADAPT-ITT; 2) pre-pilot the adapted intervention via an open non-randomized pilot study to further refine the culturally adapted intervention; and 3) conduct a 2-armed randomized pilot test of the behavioral intervention compared to standard of care to assess the feasibility and acceptability the adapted MBSR intervention for Black WLWH. The investigator hypothesis that the adapted intervention will be feasible and acceptable to member of the target population.

Conditions

HIV Infections; Health Behavior

Outcome Measures

Primary Outcomes (1)

• Feasibility Intervention Measure

  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

ACTIVE COMPARATOR

MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.

Behavioral: Mindfulness

Standard of Care

NO INTERVENTION

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

Interventions

Mindfulness BEHAVIORAL

The traditional MBSR intervention consists of the following: (1) a series of eight weekly session of 2.5 to 3 hours; (2) a silent retreat during the sixth week; (3) daily home assignments including formal and informal mindfulness practices; and (4) didactic presentations on stress and the consequences of stress. We are culturally tailoring the intervention with the goal of maintain fidelity.

Mindfulness Based Stress Reduction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants are required to be born a female.
• 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.

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
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UAB School of Nursing

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

HIV Infections; Health Behavior

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; Behavior

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This is a feasibility. Therefore, we were not powered to detect changes in specific outcome measures. The primary outcome was feasibility.

Results Point of Contact

• Title: Crystal Chapman Lambert
• Organization: School of Nursing at the 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: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: February 11, 2022
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: April 18, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)