A Mindfulness Approach to UA for Afro-descendants

NCT ID: NCT05881681

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2024-02-05

Brief Summary

The goal of this clinical trial is to test an app-based mindfulness training program in an Afro-descendant population. The main question[s] it aims to answer are:

• What changes, if any, does the app need?
• Is it effective in reducing anxiety among this population?

Participants will be asked to:

• Use an app-based mindfulness training program daily
• Complete online surveys at baseline and 2 months post-treatment initiation
• Complete focused interviews via Zoom at baseline and 2 months post-treatment initiation
• Complete daily voice diaries via Zoom

Conditions

Anxiety; Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

App-Delivered Mindfulness Training (MT)

The Unwinding Anxiety program is delivered via a smartphone-based platform, which includes a progression through 30+ daily modules of brief didactic and experience-based mindfulness training (videos and animations), app-triggered check-ins to encourage engagement, and user-initiated guided mindfulness exercises to help disrupt worry cycles in the moment.

Group Type: EXPERIMENTAL

App-Delivered Mindfulness Training (MT)

Intervention Type: BEHAVIORAL

Unwinding Anxiety is an app-delivered mindfulness training program which includes a progression through 30+ daily modules. Each module's training is delivered via short video tutorials and animations (\~10 min/day). Each training builds on the previous one; modules are 'locked' so that they can only be viewed at a pace of 1/day (previous modules can be reviewed at any time). A built-in self-assessment is taken after every seven modules to ensure key concepts are learned before moving on with automated suggestions on which modules to repeat based on the self-assessment results. User-initiated guided practices range from short exercises (30 seconds) to manage anxiety the moment it arises to formal guided meditations (up to 15 minutes), and can be accessed at any time

Interventions

App-Delivered Mindfulness Training (MT)

Unwinding Anxiety is an app-delivered mindfulness training program which includes a progression through 30+ daily modules. Each module's training is delivered via short video tutorials and animations (\~10 min/day). Each training builds on the previous one; modules are 'locked' so that they can only be viewed at a pace of 1/day (previous modules can be reviewed at any time). A built-in self-assessment is taken after every seven modules to ensure key concepts are learned before moving on with automated suggestions on which modules to repeat based on the self-assessment results. User-initiated guided practices range from short exercises (30 seconds) to manage anxiety the moment it arises to formal guided meditations (up to 15 minutes), and can be accessed at any time

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• GAD-7 ≥ 10
• Self-identify as Black American and/or Afro-descendant
• Located in United States or Canada
• Able to speak English
• Owns a smartphone

Exclusion Criteria

• Any usage of psychotropic medication: not on a stable dosage 6+ weeks
• As needed (i.e., prn) benzodiazepine use
• Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)
• Cohabiting with a study participant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Richard King Mellon Foundation

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judson A Brewer

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

2112003165

Identifier Type: -

Identifier Source: org_study_id