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

NCT ID: NCT04984681

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2022-12-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness

Intervention Type: 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

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

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Crystal C. Lambert

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UAB School of Nursing

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23AT010567

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23AT010567S

Identifier Type: -

Identifier Source: org_study_id