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

Mindfulness-Based Stress Reduction App for African American Caregivers of People With Chronic Conditions

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress
• Intervention / Treatment: Behavioral: Mindfulness app

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Friends Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arms and Interventions; Mindfulness App Use Participants will have the opportunity to use the mindfulness app for four weeks.	Behavioral: Mindfulness app; The mindfulness app contains 6 modules with a variety of features to help caregivers reduce their stress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress	Perceived stress scores entered into the app by the participant	4 weeks

Collaborators and Investigators

• Sponsor: COG Analytics
• Collaborators: Friends Research Institute, Inc.
• Investigators: Principal Investigator: Mary M Mitchell, Ph.D., Friends Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1R41AG071168-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: None formulated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No