A Mindfulness Approach to UA for Afro-descendants

Brown University15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anxiety Stress

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Focused interviews

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

Time frame: Baseline

Focused interviews

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

Time frame: 2 months

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: Baseline, 2 months

Data from ClinicalTrials.gov

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