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

Study Overview
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Brief Summary
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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).

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

Conditions
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HIV Infections, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Mindfulness
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based Stress Reduction<br>Mindfulness-based stress reduction sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview. | Behavioral: Mindfulness<br>* 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.<br>|
| Other: Usual Care<br>The control condition will continue receiving usual care or standard of care. | Other: Usual Care<br>* The control condition will continue receiving usual care or standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Acceptability | participants' satisfaction with the intervention including length, content, interventionists, practices, setting, and contextual factors. | Immediately post-intervention or 8 weeks. | 
| Neurocognitive Function | Speed of information processing, Executive Function, Learning and memory, verbal fluency and everyday functioning. | Immediately post-intervention or 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | Adherence will be measured by the single-item antiretroviral therapy question. Higher scores indicate better antiretroviral therapy adherence. | Immediately post-intervention | 
| Perceived Stress | Perceived stress will be measures using the perceived stress scale (PSS), with higher scores indicating higher perceived stress. | Immediately post-intervention | 
| Mental Distress | Mood will be assessed using the PHQ-8. Higher scores are indicate increased symptom severity. | immediately post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Cisgender women, African American or Black, Mindfulness