Investigating How the Brain Processes Different Experiences

Not Applicable

• Conditions: Anxiety

• Registration Number: NCT06051084
• Lead Sponsor: Brown University

Brief 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.

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 Timeline

• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-22
• Study Start: 2023-10-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 125

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in GAD - 7	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	collected at baseline and 2 month follow up apt	BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping

Secondary Outcome Measures

Name	Time	Method
Penn State Worry Questionnaire (PSWQ)	collected at baseline and 2 month follow up apt	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).
Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale	collected at baseline and 2 month follow up apt	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).

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States