A Mindfulness Approach to UA for Afro-descendants

NCT05881681 | Completed

• 1 other identifier: 2112003165
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Worry

Outcome Measures

Primary Outcomes (2)

• Focused interviews

  In-depth interviews will be conducted to collect participant feedback.

  Baseline

• Focused interviews

  In-depth interviews will be conducted to collect participant feedback.

  2 months

Secondary Outcomes (3)

• Change in anxiety

  Baseline, 2 months

• Change in worry

  Baseline, 2 months

• Change in non-reactivity

  Baseline, 2 months

Study Arms (1)

App-Delivered Mindfulness Training (MT)

EXPERIMENTAL

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.

Behavioral: App-Delivered Mindfulness Training (MT)

Interventions

App-Delivered Mindfulness Training (MT) 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

App-Delivered Mindfulness Training (MT)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• Richard King Mellon Foundation: collaborator
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15215, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Judson A Brewer

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: May 31, 2023
• Study Start: September 6, 2022
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)