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A Mindfulness Approach to UA for Afro-descendants

Primary Purpose

Anxiety, Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App-Delivered Mindfulness Training (MT)
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Worry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

App-Delivered Mindfulness Training (MT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
November 4, 2022
Last Updated
May 19, 2023
Sponsor
Brown University
Collaborators
Richard King Mellon Foundation, University of Pittsburgh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05881681
Brief Title
A Mindfulness Approach to UA for Afro-descendants
Official Title
A Mindfulness Approach to Unwinding Anxiety for Afro-descendants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
Richard King Mellon Foundation, University of Pittsburgh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress
Keywords
Worry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
App-Delivered Mindfulness Training (MT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
App-Delivered Mindfulness Training (MT)
Intervention Description
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 Outcome Measure Information:
Title
Focused interviews
Description
In-depth interviews will be conducted to collect participant feedback.
Time Frame
Baseline
Title
Focused interviews
Description
In-depth interviews will be conducted to collect participant feedback.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change in anxiety
Description
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
Title
Change in worry
Description
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
Title
Change in non-reactivity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judson A Brewer
Phone
‪(401) 863-2826
Email
judson_brewer@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judson A Brewer
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judson A. Brewer, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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A Mindfulness Approach to UA for Afro-descendants

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