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Completed

NCT Number: NCT05881681

A Mindfulness Approach to UA 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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Focused interviews

    Time frame: Baseline

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

  2. Focused interviews

    Time frame: 2 months

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

Secondary outcomes

  1. Change in anxiety

    Time frame: 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.

  2. Change in worry

    Time frame: 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

  3. Change in non-reactivity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Richard King Mellon Foundation
  • University of Pittsburgh Medical Center

Registry information

Official study title

A Mindfulness Approach to Unwinding Anxiety for Afro-descendants

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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