A Mindfulness Approach to UA for Afro-descendants

Study Overview
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Brief Summary
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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

Official Title
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A Mindfulness Approach to Unwinding Anxiety for Afro-descendants

Conditions
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Anxiety, Stress

Intervention / Treatment
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* Behavioral: App-Delivered Mindfulness Training (MT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-Delivered Mindfulness Training (MT)<br>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)<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Worry