AnxietyNCT06051084
Investigating How the Brain Processes Different Experiences
A study testing App-Delivered Mindfulness Training (MT) and App-Delivered Coloring in people with Anxiety, run by Brown University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the efficacy of an app-based program in reducing anxiety and exploring associated changes in brain activity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- App-Delivered Mindfulness Training (MT) and App-Delivered Coloring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 31 Mar 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 65 years
- Able to travel to Brown University for research assessment
- Able to speak English because all study activities will be conducted in English.
- GAD-7 ≥ 10
- Owns a smartphone
Who cannot join
- If using psychotropic medication - not on a stable dosage at least 6 weeks
- As needed (i.e., prn) benzodiazepine use
- Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)
- MRI contraindications
- Claustrophobia
- Recreational drug use past 2 weeks
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- Alcohol abuse
- Pregnancy or plans to become pregnant
- Cohabiting with a study participant
- Weight ≥ 300 lbs (due to inability to fit in scanner)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advancing Our Understanding and Treatment of Anxiety Through Bringing Together Facets of Conscious Experience and Brain Mechanisms: Open/Closed Meets the Default Mode Network
The goal of this clinical trial is to test the efficacy of an app-based program in reducing anxiety and exploring associated changes in brain activity.
Read the detailed description
The main question[s] it aims to answer are:
PRIMARY AIM: Confirm that the conscious experience of open/closed correlates with P/PCC activation/deactivation.
SECONDARY AIM: Determine if changes in P/PCC activity predict clinical outcomes (GAD-7 scores) in individuals with moderate to severe anxiety after using an app.
Participants may be asked to:
- Complete a Zoom interview
- Complete online surveys at baseline and 2 months post-treatment initiation
- Complete MRIs at baseline and 2 months post-treatment initiation
- Wear a smartwatch and answer daily questions about their anxiety
- Use an app daily
- Conditions
- Anxiety
- Being tested
- App-Delivered Mindfulness Training (MT), App-Delivered Coloring
- Keywords
- Anxiety, Mindfulness, MRI, Cell Phone
- 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
The 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.
App-Delivered ColoringBehavioural
An app-based coloring book with a variety of designs to choose from including mandalas, animal patterns, and florals. It is designed to help individuals relax and reduce stress and anxiety based on the benefits found in past research studies.
| Study group | Role | What they receive |
|---|---|---|
| App-Delivered Mindfulness Training (MT) | Experimental | The 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) |
| App-Delivered Coloring | Active comparator | An app-based coloring book with a variety of designs to choose from including mandalas, animal patterns, and florals. It is designed to help individuals relax and reduce stress and anxiety based on the benefits found in past research studies. Receives: Behavioral: App-Delivered Coloring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GAD - 7
Generalized Anxiety Disorder 7-items (GAD-7). The GAD-7 is a validated 7-item measure of anxiety rated on a 4-point Likert scale ranging from 0 (Not at all sure) to 3 (Nearly every day).
Measured: collected at baseline and 2 month follow up apt
Change From Baseline in Posterior Cingulate Cortex (PCC) Blood Oxygen Level Dependent (BOLD) Signal
BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
Measured: collected at baseline and 2 month follow up apt
Secondary outcomes (2)
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a validated 16-item self-report measure of worry with items presented on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me).
Measured: collected at baseline and 2 month follow up apt
Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale
The non-reactivity scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 7 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).
Measured: collected at baseline and 2 month follow up apt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start5 Oct 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, Tiny Blue Dot Foundation
- Responsible party
- Sponsor
- Investigators
- Judson Brewer, MD, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051084
- Sponsor's protocol ID
- 2022003264
- Status last verified
- Mar 2024
- First submitted
- 18 Sep 2023
- 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
- Advancing Our Understanding and Treatment of Anxiety Through Bringing Together Facets of Conscious Experience and Brain Mechanisms: Open/Closed Meets the Default Mode Network
- ClinicalTrials.gov ID
- NCT06051084
- Acronym / sponsor ID
- 2022003264
- Conditions
- Anxiety
- Keywords
- Anxiety, Mindfulness, MRI, Cell Phone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Dartmouth College, Tiny Blue Dot Foundation
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Sep 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 the efficacy of an app-based program in reducing anxiety and exploring associated changes in brain activity.
Detailed description
The main question[s] it aims to answer are:
PRIMARY AIM: Confirm that the conscious experience of open/closed correlates with P/PCC activation/deactivation.
SECONDARY AIM: Determine if changes in P/PCC activity predict clinical outcomes (GAD-7 scores) in individuals with moderate to severe anxiety after using an app.
Participants may be asked to:
- Complete a Zoom interview
- Complete online surveys at baseline and 2 months post-treatment initiation
- Complete MRIs at baseline and 2 months post-treatment initiation
- Wear a smartwatch and answer daily questions about their anxiety
- Use an app daily
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-Delivered Mindfulness Training (MT) | Experimental | Behavioral: App-Delivered Mindfulness Training (MT)The 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. |
| App-Delivered Coloring | Active comparator | Behavioral: App-Delivered ColoringAn app-based coloring book with a variety of designs to choose from including mandalas, animal patterns, and florals. It is designed to help individuals relax and reduce stress and anxiety based on the benefits found in past research studies. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 - 65 years
- Able to travel to Brown University for research assessment
- Able to speak English because all study activities will be conducted in English.
- GAD-7 ≥ 10
- Owns a smartphone
Key exclusion criteria (10 listed)
- If using psychotropic medication - not on a stable dosage at least 6 weeks
- As needed (i.e., prn) benzodiazepine use
- Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)
- MRI contraindications
- Claustrophobia
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)The 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. | Behavioural | App-Delivered Mindfulness Training (MT) |
| App-Delivered ColoringAn app-based coloring book with a variety of designs to choose from including mandalas, animal patterns, and florals. It is designed to help individuals relax and reduce stress and anxiety based on the benefits found in past research studies. | Behavioural | App-Delivered Coloring |
Primary outcome
Change in GAD - 7
Time frame: collected at baseline and 2 month follow up apt
Generalized Anxiety Disorder 7-items (GAD-7). The GAD-7 is a validated 7-item measure of anxiety rated on a 4-point Likert scale ranging from 0 (Not at all sure) to 3 (Nearly every day).
Change From Baseline in Posterior Cingulate Cortex (PCC) Blood Oxygen Level Dependent (BOLD) Signal
Time frame: collected at baseline and 2 month follow up apt
BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
2 secondary outcomes
Penn State Worry Questionnaire (PSWQ)
Time frame: collected at baseline and 2 month follow up apt
Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale
Time frame: collected at baseline and 2 month follow up apt
Results and safety
Results are not available in the source record.
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 Brewer, MD, PhD 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) and App-Delivered Coloring in people with Anxiety, 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 10 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: status not confirmed, 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?
Results are not available in the source record.
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?
Change in GAD - 7 (time frame: collected at baseline and 2 month follow up apt). 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.