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

Primary Purpose

HIV Infections, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Usual Care
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Infections focused on measuring HIV, Cisgender women, African American or Black, Mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mindfulness-based Stress Reduction

Usual Care

Arm Description

Mindfulness-based stress reduction sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.

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

Outcomes

Primary Outcome Measures

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.
Acceptability
participants' satisfaction with the intervention including length, content, interventionists, practices, setting, and contextual factors.
Neurocognitive Function
Speed of information processing, Executive Function, Learning and memory, verbal fluency and everyday functioning.

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2021
Last Updated
February 5, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04984681
Brief Title
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV Supplement
Official Title
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV Administrative Supplement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Mild Cognitive Impairment
Keywords
HIV, Cisgender women, African American or Black, Mindfulness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based Stress Reduction
Arm Type
Experimental
Arm Description
Mindfulness-based stress reduction sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.
Arm Title
Usual Care
Arm Type
Other
Arm Description
The control condition will continue receiving usual care or standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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
Other
Intervention Name(s)
Usual Care
Intervention Description
The control condition will continue receiving usual care or standard of care.
Primary Outcome Measure Information:
Title
Feasibility of the mindfulness intervention in women with mild cognitive impairment
Description
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.
Time Frame
Immediately post-intervention or 8 weeks.
Title
Acceptability
Description
participants' satisfaction with the intervention including length, content, interventionists, practices, setting, and contextual factors.
Time Frame
Immediately post-intervention or 8 weeks.
Title
Neurocognitive Function
Description
Speed of information processing, Executive Function, Learning and memory, verbal fluency and everyday functioning.
Time Frame
Immediately post-intervention or 8 weeks.
Secondary Outcome Measure Information:
Title
Medication Adherence
Description
Adherence will be measured by the single-item antiretroviral therapy question. Higher scores indicate better antiretroviral therapy adherence.
Time Frame
Immediately post-intervention
Title
Perceived Stress
Description
Perceived stress will be measures using the perceived stress scale (PSS), with higher scores indicating higher perceived stress.
Time Frame
Immediately post-intervention
Title
Mental Distress
Description
Mood will be assessed using the PHQ-8. Higher scores are indicate increased symptom severity.
Time Frame
immediately post-intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
We are recruiting cisgender females.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
UAB School of Nursing
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The University of Alabama at Birmingham maintains the following universal data sharing policy for all investigators: Data will be made available, in accordance with the NIH Data Sharing Policy (http://grants.nih.gov/grants/policy/data_sharing) to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. In some cases the institution may determine that the public and the research community are better served by a licensing program whether or not patents have been filed. This may be relevant, for example, if a tool is best distributed under license to guarantee reagent availability and quality. As a means of sharing knowledge, NIH encourages grantees to arrange for publication of NIH-supported original research in primary scientific journals. We therefore will strive to publish our findings in a timely manner and acknowledge that the research was supported by the NIH.

Learn more about this trial

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

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