A Mindfulness Approach to UA for Afro-descendants

Anxiety Clinical Trial

Official title:

A Mindfulness Approach to Unwinding Anxiety for Afro-descendants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881681
• Other study ID #: 2112003165
• Status: Completed
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: February 5, 2024

Study information

• Verified date: March 2024
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	Richard King Mellon Foundation, University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Focused interviews	In-depth interviews will be conducted to collect participant feedback.	Baseline
Primary	Focused interviews	In-depth interviews will be conducted to collect participant feedback.	2 months
Secondary	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
Secondary	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
Secondary	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