Stress ReductionNCT06079840
Mindfulness Based Stress Reduction App
A study testing mindfulness-based stress reduction app in people with Stress Reduction, run by COG Analytics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Reduction
- What is being tested?
- mindfulness-based stress reduction app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to provide informed consent (e.g., compromised comprehension).
Trial locations and contacts
1 site in 1 country.
United States1 site
Friends Research Institute
Baltimore, Maryland, 21201
About this study
Official title: Mindfulness Based Stress Reduction App for African American Caregivers
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.
Read the 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.
- Conditions
- Stress Reduction
- Being tested
- mindfulness-based stress reduction app
- Keywords
- Digital intervention, Mindfulness, Stress reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based stress reduction appDevice
mobile application (app) for caregivers
| Study group | Role | What they receive |
|---|---|---|
| MBSR-AAC app | Experimental | Participants will receive the MBSR-AAC app for 8-weeks. Receives: Device: mindfulness-based stress reduction app |
| Comparison | Active comparator | Participants will receive information regarding caregiver services and resources for 8-weeks. Receives: Device: mindfulness-based stress reduction app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived caregiver stress
The degree to which stressful situations occurred during a specific period of time.
Measured: 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.
Measured: Up to 12 weeks
Caregiver-care recipient relationships
The degree to which the caregiver feels close to the care recipient
Measured: Up to 12 weeks
Caregiver burden
An assessment of various dimensions of caregiver burden (e.g., isolation, relationship strain, privacy, social life, and health).
Measured: Up to 12 weeks
Caregiver depressive and anxiety symptoms
An assessment of caregiver clinical symptoms of depression and anxiety.
Measured: Up to 12 weeks
Secondary outcomes (1)
Stigma and discrimination
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start18 Mar 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- COG Analytics
- Sponsor type
- University, hospital or other
- Collaborators
- Friends Research Institute, Inc.
- Responsible party
- Sponsor
- Investigators
- Steven B Carswell, Ph.D., Principal investigator, COG Analytics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079840
- Sponsor's protocol ID
- 2R44AG071168-02
- Status last verified
- Jan 2026
- First submitted
- 8 Oct 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Stress Reduction App for African American Caregivers
- ClinicalTrials.gov ID
- NCT06079840
- Acronym / sponsor ID
- 2R44AG071168-02
- Conditions
- Stress Reduction
- Keywords
- Digital intervention, Mindfulness, Stress reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- COG AnalyticsUniversity, hospital or other
- Collaborators
- Friends Research Institute, Inc.
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MBSR-AAC app | Experimental | Device: mindfulness-based stress reduction appParticipants will receive the MBSR-AAC app for 8-weeks. |
| Comparison | Active comparator | Device: mindfulness-based stress reduction appParticipants will receive information regarding caregiver services and resources for 8-weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to provide informed consent (e.g., compromised comprehension).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based stress reduction appmobile application (app) for caregivers | Device | Comparison, MBSR-AAC app |
Primary outcome
Perceived caregiver stress
Time frame: Up to 12 weeks
The degree to which stressful situations occurred during a specific period of time.
Caregiver self-compassion
Time frame: Up to 12 weeks
Caregiver self-kindness, common humanity, mindfulness, self-judgment, isolation, and over-identification during a specific period of time.
Caregiver-care recipient relationships
Time frame: Up to 12 weeks
The degree to which the caregiver feels close to the care recipient
Caregiver burden
Time frame: Up to 12 weeks
An assessment of various dimensions of caregiver burden (e.g., isolation, relationship strain, privacy, social life, and health).
Caregiver depressive and anxiety symptoms
Time frame: Up to 12 weeks
An assessment of caregiver clinical symptoms of depression and anxiety.
1 secondary outcome
Stigma and discrimination
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Related trials for Stress Reduction
Enrolling by invitation
Adaptation and Evaluation of RESTORE
Nurse, Burnout, Healthcare Workers
Recruiting
Applying CSNAT in HBPC as an Approach to Elder Mistreatment Risk Reduction
Caregiver Stress, Caregiver Health Related QOL
Active, not recruiting
Pilot MBSR for People With HS
Hidradenitis Suppurativa (HS)
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
RecruitingPhase 2
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
Acute Stress Reaction, Acute Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven B Carswell, Ph.D. principal investigator
COG Analytics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based stress reduction app in people with Stress Reduction, run by COG Analytics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived caregiver stress (time frame: Up to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.