A Mindfulness Approach to UA for Afro-descendants

Not Applicable

Completed

• Conditions: Stress; Anxiety
• Interventions: Behavioral: App-Delivered Mindfulness Training (MT)

• Registration Number: NCT05881681
• Lead Sponsor: Brown University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-06
• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-31
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
App-Delivered Mindfulness Training (MT)	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.

Primary Outcome Measures

Name	Time	Method
Focused interviews	2 months	In-depth interviews will be conducted to collect participant feedback.

Secondary Outcome Measures

Name	Time	Method
Change in worry	Baseline, 2 months	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
Change in anxiety	Baseline, 2 months	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.
Change in non-reactivity	Baseline, 2 months	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.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States