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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UAB School of Nursing

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Usual Care

Other

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

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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jul 30, 2021
Registry last updated: Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed