Trial Outcomes & Findings for Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV (NCT NCT04193605)

NCT ID: NCT04193605

Last Updated: 2024-04-18

Results Overview

Feasibility was measured using a four-item feasibility of intervention measure. Each item is scored using a Likert-like scale ranging from "1" completely disagree to "5" completely agree. Higher scores indicate greater feasibility. The minimum total score is 4 points, and the maximum total score is 20.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.

Results posted on

2024-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Mindfulness Based Stress Reduction MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview. Mindfulness: 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.	Standard of Care The control condition will continue receiving usual care or standard of care.
Overall Study STARTED	24	24
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness Based Stress Reduction n=24 Participants MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview. Mindfulness: 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.	Standard of Care n=24 Participants The control condition will continue receiving usual care or standard of care.	Total n=48 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 10.9 • n=5 Participants	47.4 years STANDARD_DEVIATION 7.5 • n=7 Participants	47.1 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.

Population: Participants in the standard of care did not receive the intervention. Therefore, data was not collected or analyzed on these participants

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction n=21 Participants MBSR sessions received by the treatment group will include an orientation, approximately 8 intervention sessions, and an exit interview. Mindfulness: 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.	Standard of Care The control condition will continue receiving usual care or standard of care.
Feasibility Intervention Measure	18 units on a scale Standard Deviation 2.4	—

Adverse Events

Mindfulness Based Stress Reduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Crystal Chapman Lambert

School of Nursing at the University of Alabama at Birmingham

Phone: 205-934-3481

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place