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

Primary Purpose

HIV Infections, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
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

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.

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

Active Comparator

No Intervention

Arm Label

Mindfulness Based Stress Reduction

Standard of Care

Arm Description

MBSR 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

Adherence
Adherence will be measured by the single-item antiretroviral therapy question. Higher scores indicate better ART 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.
Physical
Physical symptoms will measured by the AIDS Clinical Trial group HIV symptom index. A higher score indicate more symptoms.

Secondary Outcome Measures

Social support
Social support will be measured using the abbreviated medical outcome study social support scale (MOS4). Higher scores indicate higher social support.
Mindfulness
Mindfulness will be measured using the five facet mindfulness scale (FFMQ-SF) with higher scores indicating more mindfulness.

Full Information

First Posted
December 5, 2019
Last Updated
September 9, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04193605
Brief Title
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV
Official Title
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
October 12, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

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
The investigator propose to culturally adapt the mindfulness-based stress reduction (MSBR) intervention for Black/African American women living with HIV (WLWH) to reduce stress and enhance HIV self-care behaviors and viral load (VL) suppression, which has the potential to attenuate prominent racial and gender disparities experienced by Black WLWH in the US. Specifically, the investigator aims to 1) culturally adapt the MBSR intervention for Black WLWH using ADAPT-ITT; 2) pre-pilot the adapted intervention via an open non-randomized pilot study to further refine the culturally adapted intervention; and 3) conduct a 2-armed randomized pilot test of the behavioral intervention compared to standard of care to assess the feasibility and acceptability the adapted MBSR intervention for Black WLWH. The investigator hypothesis that the adapted intervention will be feasible and acceptable to member of the target population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Health Behavior

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Stress Reduction
Arm Type
Active Comparator
Arm Description
MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview.
Arm Title
Standard of Care
Arm Type
No Intervention
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 MBSR intervention consists of the following: (1) a series of eight weekly session of 2.5 to 3 hours; (2) a silent retreat during the sixth week; (3) daily home assignments including formal and informal mindfulness practices; and (4) didactic presentations on stress and the consequences of stress. We are culturally tailoring the intervention with the goal of maintain fidelity.
Primary Outcome Measure Information:
Title
Adherence
Description
Adherence will be measured by the single-item antiretroviral therapy question. Higher scores indicate better ART adherence.
Time Frame
Immediately post-intervention or 8 weeks.
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 or 8 weeks.
Title
Mental Distress
Description
Mood will be assessed using the PHQ-8. Higher scores are indicate increased symptom severity.
Time Frame
Immediately post-intervention or 8 weeks.
Title
Physical
Description
Physical symptoms will measured by the AIDS Clinical Trial group HIV symptom index. A higher score indicate more symptoms.
Time Frame
Immediately post-intervention or 8 weeks.
Secondary Outcome Measure Information:
Title
Social support
Description
Social support will be measured using the abbreviated medical outcome study social support scale (MOS4). Higher scores indicate higher social support.
Time Frame
Immediately post-intervention or 8 weeks.
Title
Mindfulness
Description
Mindfulness will be measured using the five facet mindfulness scale (FFMQ-SF) with higher scores indicating more mindfulness.
Time Frame
Immediately post-intervention or 8 weeks.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants are required to be born a female.
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. 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
UAB 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

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