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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05547776
• Other study ID #: 1R41AG071168-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: October 2022

Study information

• Verified date: September 2022
• Source: COG Analytics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

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

Locations

Country	Name	City	State
United States	Friends Research Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
COG Analytics	Friends Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress	Perceived stress scores entered into the app by the participant	4 weeks