Mindfulness Based Stress Reduction App

Sponsor
COG Analytics (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06079840
Collaborator
Friends Research Institute, Inc. (Other)
100
2
19

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: mindfulness-based stress reduction app
N/A

Detailed Description

Building upon prior research regarding mindfulness-based stress reduction interventions, during Phase I, we successfully developed a prototype mobile application (app) for caregivers entitled Mindfulness Based Stress Reduction for African American Caregivers (MBSR-AAC). Based on the Health Stigma and Discrimination Framework, components of the app focus on decreasing stress associated with intersecting sources of stigma, discrimination, and caregiving burdens specifically associated with caregiving for people living with HIV/AIDS (PLWHA). In the present Phase II SBIR study, we will build on Phase I findings to incorporate research-driven enhancements to the app, conduct a feasibility trial of the enhanced app, and conduct a randomized clinical trial to examine the effectiveness of the app in reducing caregiver stress. If proven to be effective, the MBSR-AAC app could have a positive impact on the well-being of African American caregivers that serve as a critical pillar of support for many PLWHA.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Mindfulness Based Stress Reduction App for African American Caregivers
Anticipated Study Start Date :
Mar 1, 2024
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: MBSR-AAC app

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

Device: mindfulness-based stress reduction app
mobile application (app) for caregivers

Active Comparator: Comparison

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

Device: mindfulness-based stress reduction app
mobile application (app) for caregivers

Outcome Measures

Primary Outcome Measures

  1. Perceived caregiver stress [Up to 12 weeks]

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

  2. Caregiver self-compassion [Up to 12 weeks]

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

  3. Caregiver-care recipient relationships [Up to 12 weeks]

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

  4. Caregiver burden [Up to 12 weeks]

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

  5. Caregiver depressive and anxiety symptoms [Up to 12 weeks]

    An assessment of caregiver clinical symptoms of depression and anxiety.

Secondary Outcome Measures

  1. Stigma and discrimination [Up to 12 weeks]

    An assessment of caregiver general feelings of shame, rejection, and avoidance and an assessment of discrimination experiences in the day-to-day lives of caregivers.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • COG Analytics
  • Friends Research Institute, Inc.

Investigators

  • Principal Investigator: Steven B Carswell, Ph.D., COG Analytics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
COG Analytics
ClinicalTrials.gov Identifier:
NCT06079840
Other Study ID Numbers:
  • 2R44AG071168-02
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by COG Analytics

Study Results

No Results Posted as of Oct 13, 2023