Mindfulness Based Stress Reduction App for African American Caregivers (MBSR)

NCT ID: NCT05547776

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2022-10-31

Brief Summary

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The study investigators are developing and testing a mobile-friendly web-based app that contains features related to mindfulness and reducing stress for African American informal caregivers of people with chronic conditions. The purpose of the app is to help a vulnerable population reduce stress by learning and practicing mindfulness activities.

Detailed Description

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For Aim 1, the study investigators conducted 10 formative interviews with African American caregivers and key informants to elicit recommendations for features to be included in the app as well as feedback on preliminary ideas for features. For Aim 2, the study investigators developed the programming for the app with the desired features, which included modules for journaling, tracking stress ratings, practicing mindfulness exercises by using two videos and two audio tracks developed for the app, and viewing weekly suggestions for caregiver/care recipient bonding activities, inspirational quotes and positive affirmations. For Aim 3, the study investigators are testing the app using a feasibility trial with 30 caregiver participants. The study participants answer questions on depression, anxiety, perceived stress, overload and self-compassion at baseline and follow-up. Participants are instructed to use the app for four weeks and to return for their follow-up visit to fill out the same surveys assessed at baseline plus a satisfaction questionnaire to assess their evaluation of the app. These data will inform future enhancements, which will be proposed in a Phase II SBIR/STTR application.

Conditions

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Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a feasibility trial with a single group of 30 participants who are using an app and providing feedback on the app.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arms and Interventions

Mindfulness App Use

Participants will have the opportunity to use the mindfulness app for four weeks.

Group Type EXPERIMENTAL

Mindfulness app

Intervention Type BEHAVIORAL

The mindfulness app contains 6 modules with a variety of features to help caregivers reduce their stress.

Interventions

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Mindfulness app

The mindfulness app contains 6 modules with a variety of features to help caregivers reduce their stress.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Informal caregiver participants will be screened for the ability to speak English. In addition, the caregivers must currently be providing support for a person living with HIV. Support can include: 1) emotional support, 2) physical support, 3) financial support, 4) opportunities for social participation, and/or 5) health advice.

Exclusion Criteria

* Psychiatric problems such as untreated psychosis, which could preclude their ability to successfully adhere to the intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Friends Research Institute, Inc.

OTHER

Sponsor Role collaborator

COG Analytics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary M Mitchell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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Friends Research Institute

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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1R41AG071168-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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