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

Not Applicable

Active, not recruiting

• Conditions: Stress
• Interventions: Behavioral: Mindfulness app

• Registration Number: NCT05547776
• Lead Sponsor: COG Analytics

Brief Summary

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

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 Timeline

• Study Start: 2022-07-18
• Status Verified: 2022-09
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-20
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-22
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arms and Interventions	Mindfulness app	Mindfulness App Use Participants will have the opportunity to use the mindfulness app for four weeks.

Primary Outcome Measures

Name	Time	Method
Perceived Stress	4 weeks	Perceived stress scores entered into the app by the participant

Trial Locations

Locations (1)

Friends Research Institute; 🇺🇸 Baltimore, Maryland, United States