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Clinical Trials/NCT05547776
NCT05547776
Active, not recruiting
Not Applicable

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

COG Analytics1 site in 1 country30 target enrollmentJuly 18, 2022
ConditionsStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
COG Analytics
Enrollment
30
Locations
1
Primary Endpoint
Perceived Stress
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 18, 2022
End Date
October 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
COG Analytics
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Perceived Stress

Time Frame: 4 weeks

Perceived stress scores entered into the app by the participant

Study Sites (1)

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