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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04984681
• Other study ID #: K23AT010567S
• Secondary ID: K23AT010567
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: December 14, 2022

Study information

• Verified date: February 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 14, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• HIV Infections
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	UAB School of Nursing	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the mindfulness intervention in women with mild cognitive impairment	Feasibility will be assessed through the following: recruitment of 30 participants over a period of 12 weeks (3 months); completion of post-intervention survey and exit interview by 75% of participants; 66% (n=9-10) of participants will attend 6 out of 8 sessions remotely or face-to-face and 50% (n= 7-8) of participants will attend the all-day retreat; and 80% of participants (n=24) will be retained throughout the study. We will assess fidelity with the goal of 80% or greater adherence to the intervention manual. Percent of home practice completed over 8 weeks will be assessed via self-report.	Immediately post-intervention or 8 weeks.
Primary	Acceptability	participants' satisfaction with the intervention including length, content, interventionists, practices, setting, and contextual factors.	Immediately post-intervention or 8 weeks.
Primary	Neurocognitive Function	Speed of information processing, Executive Function, Learning and memory, verbal fluency and everyday functioning.	Immediately post-intervention or 8 weeks.
Secondary	Medication Adherence	Adherence will be measured by the single-item antiretroviral therapy question. Higher scores indicate better antiretroviral therapy adherence.	Immediately post-intervention
Secondary	Perceived Stress	Perceived stress will be measures using the perceived stress scale (PSS), with higher scores indicating higher perceived stress.	Immediately post-intervention
Secondary	Mental Distress	Mood will be assessed using the PHQ-8. Higher scores are indicate increased symptom severity.	immediately post-intervention