Clinical trial NCT06051084: Investigating How the Brain Processes Different Experiences
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Mindfulness
MRI
Cell Phone
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: Tiny Blue Dot Foundation
First posted: 2023-09-22
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Change in GAD - 7
timeFrame: collected at baseline and 2 month follow up apt
measure: Change From Baseline in Posterior Cingulate Cortex (PCC) Blood Oxygen Level Dependent (BOLD) Signal
timeFrame: collected at baseline and 2 month follow up apt
Secondary outcomes:
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: collected at baseline and 2 month follow up apt
measure: Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale
timeFrame: collected at baseline and 2 month follow up apt
Other outcomes:
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: collected at baseline and 2 month follow up apt
measure: Anxiety Sensitivity Index (ASI)
timeFrame: collected at baseline and 2 month follow up apt
measure: Interest (I) Type and Deprivation (D) Type scale (I/D)
timeFrame: collected at baseline and 2 month follow up apt
measure: Acceptance & Action questionnaire (AAQ-II)
timeFrame: collected at baseline and 2 month follow up apt
measure: Intolerance of Uncertainty 12-item scale (IUS-12)
timeFrame: collected at baseline and 2 month follow up apt
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Judson Brewer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: