Mindfulness Based Stress Reduction App

NCT06079840 | Completed

• 1 other identifier: 2R44AG071168-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

African American caregivers of people living with HIV/AIDS (PLWHA) have unique needs because they are more likely to experience stressors related to intersecting sources of stigma, discrimination, and caregiving burdens specifically associated with caregiving for PLWHA. The proposed project will enhance and finalize Phase I app development and evaluate its effectiveness in a randomized controlled trial. The project has high public health significance because of its potential to provide an accessible, easy to use mindfulness-based support tool for African American caregivers that could reduce stress, mitigate the harm of intersecting stigmas, and strengthen the caregiver-care recipient relationship.

Conditions

Stress Reduction

Keywords

Digital intervention; Mindfulness; Stress reduction

Outcome Measures

Primary Outcomes (5)

• Perceived caregiver stress

  The degree to which stressful situations occurred during a specific period of time.

  Up to 12 weeks

• Caregiver self-compassion

  Caregiver self-kindness, common humanity, mindfulness, self-judgment, isolation, and over-identification during a specific period of time.

  Up to 12 weeks

• Caregiver-care recipient relationships

  The degree to which the caregiver feels close to the care recipient

  Up to 12 weeks

• Caregiver burden

  An assessment of various dimensions of caregiver burden (e.g., isolation, relationship strain, privacy, social life, and health).

  Up to 12 weeks

• Caregiver depressive and anxiety symptoms

  An assessment of caregiver clinical symptoms of depression and anxiety.

  Up to 12 weeks

Secondary Outcomes (1)

• Stigma and discrimination

  Up to 12 weeks

Study Arms (2)

MBSR-AAC app

EXPERIMENTAL

Participants will receive the MBSR-AAC app for 8-weeks.

Device: mindfulness-based stress reduction app

Comparison

ACTIVE COMPARATOR

Participants will receive information regarding caregiver services and resources for 8-weeks.

Device: mindfulness-based stress reduction app

Interventions

mindfulness-based stress reduction app DEVICE

mobile application (app) for caregivers

Comparison; MBSR-AAC app

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• African American
• Currently a main unpaid caregiver (defined as providing emotional, physical, and financial support) to a person living with HIV/AIDS.

You may not qualify if:

• Inability to provide informed consent (e.g., compromised comprehension).

Sponsors & Collaborators

• COG Analytics: lead
• Friends Research Institute, Inc.: collaborator

Study Sites (1)

Friends Research Institute

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Steven B Carswell, Ph.D.

  COG Analytics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The evaluation will involve a two-group RCT in which 100 African American informal caregivers of PLWHA, who previously participated in a caregiver study will be randomly assigned to one of two conditions: (1) MBSR-AAC app (n=50): Participants will receive the MBSR-AAC app for 8-weeks; or (2) Comparison (n=50): Participants will receive information regarding caregiver services and resources for 8-weeks. Assessments will be conducted with all participants at baseline and 4-, 8-, and 12-weeks post-baseline.

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: March 18, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)