A Mindfulness Approach to UA for Afro-descendants

A Mindfulness Approach to Unwinding Anxiety for Afro-descendants

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

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety
• Intervention / Treatment: Behavioral: App-Delivered Mindfulness Training (MT)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15215
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety	Generalized Anxiety Disorder 7-item will be used to assess anxiety. The GAD-7 is a 7-item questionnaire that uses a 4-point Likert scale where 0 is "Not at all" and 3 is "Nearly every day". Scores can range from 0 to 21 and higher scores indicated a worse outcome.	Baseline, 2 months
Change in worry	Penn State Worry Questionnaire (PSWQ) will be used to assess worry. The PSWQ is a 16-item questionnaire that uses a 5-point Likert scale where 1 is "Not at all typical of me" and 5 is "Very typical of me". Scores can range from 16 to 80 and higher scores indicate a worse outcome	Baseline, 2 months
Change in non-reactivity	Non-reactivity subscale from the 15-item Five Facet Mindfulness Questionnaire (FFMQ) will be used to measure changes in emotional reactivity. This subscale is based on responses to 3 questions measured on a 5-point Likert scale where 1 is "Never or rarely" and 5 is "Very often or always true". Scores can range from 3 to 15 and higher scores indicate a better outcome.	Baseline, 2 months

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: University of Pittsburgh Medical Center; Richard King Mellon Foundation
• Investigators: Principal Investigator: Judson A Brewer, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Worry
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2112003165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No