A Mindfulness Approach to UA for Afro-descendants

• Sponsor: Brown University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05881681
• Collaborator: Richard King Mellon Foundation (Other), University of Pittsburgh Medical Center (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 13.8
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Stress	Behavioral: App-Delivered Mindfulness Training (MT)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Mindfulness Approach to Unwinding Anxiety for Afro-descendants
• Actual Study Start Date: Sep 6, 2022
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

1. Focused interviews [Baseline]

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

2. Focused interviews [2 months]

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

Secondary Outcome Measures

1. 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.

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15215

Sponsors and Collaborators

• Brown University
• Richard King Mellon Foundation
• University of Pittsburgh Medical Center

Investigators

• Principal Investigator: Judson A Brewer, Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brown University
• ClinicalTrials.gov Identifier: NCT05881681
• Other Study ID Numbers: 2112003165
• First Posted: May 31, 2023
• Last Update Posted: May 31, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Brown University: Worry
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of May 31, 2023