Investigating How the Brain Processes Different Experiences

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06051084
• Other study ID #: 2022003264
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: March 31, 2025

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 the efficacy of an app-based program in reducing anxiety and exploring associated changes in brain activity.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 125
• Est. completion date: March 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 18 - 65 years

2. Able to travel to Brown University for research assessment

3. Able to speak English because all study activities will be conducted in English.

4. GAD-7 = 10

5. Owns a smartphone

Exclusion Criteria:

1. If using psychotropic medication - not on a stable dosage at least 6 weeks

2. As needed (i.e., prn) benzodiazepine use

3. Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)

4. MRI contraindications

5. Claustrophobia

6. Recreational drug use past 2 weeks

7. Alcohol abuse

8. Pregnancy or plans to become pregnant

9. Cohabiting with a study participant

10. Weight = 300 lbs (due to inability to fit in scanner)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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
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.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	Dartmouth College, Tiny Blue Dot Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Multidimensional Assessment of Interoceptive Awareness (MAIA)	The MAIA is a validated 32-item self-report questionnaire comprised of 8 subscales including: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Items are rated on a 6-point Likert scale ranging from 0 (never) to 5 (always).	collected at baseline and 2 month follow up apt
Other	Anxiety Sensitivity Index (ASI)	The ASI is a validated 16-item self-report measure of the fear of anxiety sensations. Items are rated on a 5-point Likert scale ranging from 0 (Very little) to 4 (Very much).	collected at baseline and 2 month follow up apt
Other	Interest (I) Type and Deprivation (D) Type scale (I/D)	The I/D scale is a validated 10-item self-report measure of curiosity. Items are rated on a 4-point Likert scale ranging from 1 (Almost never) to 4 (Almost always).	collected at baseline and 2 month follow up apt
Other	Acceptance & Action questionnaire (AAQ-II)	The AAQ-II is a validated 7-item self-report measure of experiential avoidance. Items are rated on a 7-point Likert scale ranging from 1 (Never true) to 7 (Always true).	collected at baseline and 2 month follow up apt
Other	Intolerance of Uncertainty 12-item scale (IUS-12)	The IUS-12 is a validated 12-item self-report measure of intolerance of uncertainty. Items are rated on a 5-point Likert scale ranging from 1 (Not at all characteristic of me) to 5 (Entirely characteristic of me).	collected at baseline and 2 month follow up apt
Primary	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).	collected at baseline and 2 month follow up apt
Primary	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	collected at baseline and 2 month follow up apt
Secondary	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).	collected at baseline and 2 month follow up apt
Secondary	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).	collected at baseline and 2 month follow up apt