AnxietyNCT05881681
A Mindfulness Approach to UA for Afro-descendants
A study testing App-Delivered Mindfulness Training (MT) in people with Anxiety and Stress, run by Brown University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- App-Delivered Mindfulness Training (MT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15215
About this study
Official title: A Mindfulness Approach to Unwinding Anxiety 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
- Being tested
- App-Delivered Mindfulness Training (MT)
- Keywords
- Worry
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-Delivered Mindfulness Training (MT)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| App-Delivered Mindfulness Training (MT) | Experimental | 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. Receives: Behavioral: App-Delivered Mindfulness Training (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focused interviews
In-depth interviews will be conducted to collect participant feedback.
Measured: Baseline
Focused interviews
In-depth interviews will be conducted to collect participant feedback.
Measured: 2 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start6 Sep 2022
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Richard King Mellon Foundation, University of Pittsburgh Medical Center
- Responsible party
- Sponsor
- Investigators
- Judson A Brewer, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881681
- Sponsor's protocol ID
- 2112003165
- Status last verified
- Mar 2024
- First submitted
- 4 Nov 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness Approach to Unwinding Anxiety for Afro-descendants
- ClinicalTrials.gov ID
- NCT05881681
- Acronym / sponsor ID
- 2112003165
- Keywords
- Worry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Richard King Mellon Foundation, University of Pittsburgh Medical Center
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| App-Delivered Mindfulness Training (MT) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | App-Delivered Mindfulness Training (MT) |
Primary outcome
Focused interviews
Time frame: Baseline
In-depth interviews will be conducted to collect participant feedback.
Focused interviews
Time frame: 2 months
In-depth interviews will be conducted to collect participant feedback.
3 secondary outcomes
Change in anxiety
Time frame: Baseline, 2 months
Change in worry
Time frame: Baseline, 2 months
Change in non-reactivity
Time frame: Baseline, 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judson A Brewer principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-Delivered Mindfulness Training (MT) in people with Anxiety and Stress, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focused interviews (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.