Mindfulness Based Stress Reduction App for African Americ... | NCT05547776

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

NCT05547776

Sponsor

COG Analytics

Status

Unknown status

Last Update Posted

Sep 22, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Stress

Interventions

Mindfulness app

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 18, 2022Actual

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Sep 16, 2022

First Submission Date that Met QC Criteria

Sep 16, 2022

First Posted Date

Sep 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2022

Last Update Posted Date

Sep 22, 2022Actual

Name	Class
Friends Research Institute, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arms and Interventions	Experimental	Mindfulness App Use Participants will have the opportunity to use the mindfulness app for four weeks.	Behavioral: Mindfulness app

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness app	Behavioral	The mindfulness app contains 6 modules with a variety of features to help caregivers reduce their stress.	Arms and Interventions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perceived Stress	Perceived stress scores entered into the app by the participant	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary M Mitchell, Ph.D.	Friends Research Institute, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Friends Research Institute		Baltimore	Maryland	21201	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

None formulated.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided