Quantifying Multi-step Avoidance in Anxiety

NCT07203027 | Not Yet Recruiting

• 2 other identifiers: STUDY000094031R01MH139780
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to learn more about avoidance behavior in people with anxiety, using mathematical models of decision-making processes and decoded neural signals of threat imminence. Researchers are investigating anxiety-related behavior and brain function in people with and without anxiety. Investigators are also looking at how behavior and brain function during tasks in the lab relate to avoidance in their daily lives. The investigators will also test whether changing how people avoid things in a behavioral task affects how people avoid things in their everyday life.

Conditions

Anxiety; Anxiety Disorders

Keywords

Avoidance behavior; Fear learning

Outcome Measures

Primary Outcomes (3)

• Ecological momentary assessment (EMA)

  Participants will complete one week of ecological momentary assessment (EMA) to assess real-world avoidance behaviors after each of the scanning visits. The proportion of assessments where participants report engaging in avoidance behavior in the last hour will be assessed. Changes in the proportion of assessments where avoidance is reported will be used to measure changes in avoidance severity.

  Baseline, week 1, week 2, week 3, and week 4

• Avoidance Severity Based on Location Entropy

  Avoidance severity will be assessed using passive sensing of daily location patterns after each fMRI scanning visit. Participants will complete one week of passive sensing of location (using phone-based GPS measures) to assess real-world avoidance behaviors after each of the scanning visits. Changes in location entropy, representing the distribution of unique locations visited per day, will be used to measure changes in avoidance severity. Lower entropy values will indicate greater avoidance severity, while higher values will indicate less avoidance.

  Baseline, week 1, week 2, week 3, and week 4

• Change in Location Entropy

  Location entropy, defined as the distribution of unique locations visited per day, will be measured using one week of passive phone-based GPS monitoring after each fMRI scanning visit. This measure reflects variability in movement patterns and real-world avoidance behaviors.

  Baseline, week 1, week 2, week 3, and week 4

Study Arms (1)

Anxiety and impairing levels of avoidance

EXPERIMENTAL

Participants are screened for anxiety and impairing levels of avoidance and will complete questionnaires, a clinical interview, behavioral tasks, scanning, ecological momentary assessment (EMA), and passive sensing. Participants will complete four visits total.

Behavioral: Behavioral Tasks with imaging

Interventions

Behavioral Tasks with imaging BEHAVIORAL

Participants will complete the MDP task only during 3 separate fMRI scanning sessions. After each session, they will complete one week of ambulatory assessment of real-world avoidance behavior (self-reported avoidance behavior) via Emory Qualtrics surveys. In a fourth scanning session, the brain signature of threat imminence constructed in the first set of participants (Aim 1) will be used to predict and modify avoidance behavior (on the task and in a further week of ambulatory assessment of avoidance) in these participants. During their last visit, the behavioral task will be modified to decrease the availability of avoidance choices; subsequent effects on EMA and passive sensing measures will be assessed.

Also known as: Investigational

Anxiety and impairing levels of avoidance

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to comprehend written and spoken English
• Ability to provide informed consent
• Estimated intelligence quotient (IQ) \>70.
• Clinically significant anxiety symptoms (scoring above clinical cutoff on at least one Inventory of Depression and Anxiety Symptoms (IDAS) anxiety-related subscale and/or OASIS total)
• Significant anxiety-related avoidance (scoring 2 or above on a 0-4 scale, indicating at least "occasional" avoidance) on the avoidance-related question on the Overall Anxiety Severity and Impairment Scale (OASIS)
• Functional impairment, defined as at least moderate impairment in one WHO Disability Assessment Schedule (WHODAS 2.0) domain related to anxiety.

You may not qualify if:

• Individuals younger than 22 or older than 55,
• Individuals with an IQ \< 70,
• A lifetime history of neurological disorder or brain damage,
• Contraindications for undergoing MRI scanning,
• A lifetime history or diagnosis of psychosis or bipolar disorder,
• Current substance use intoxication or withdrawal,
• Severe risk of suicide, or
• Recent (\<3 months) changes in psychotropic medicine or psychotherapy treatment,
• Ineligible at the PI's discretion, are excluded.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Emory College

Atlanta, Georgia, 30322, United States

Location

Facility for Education and Research in Neuroscience (FERN)

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Vanessa M Brown, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa M. Brown, PhD

CONTACT

404-727-5454; vanessa.m.brown@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 7, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will be deposited starting 12 months after the award begins (August 2026) and will be deposited every six months thereafter. The analysis code will be published upon the manuscript acceptance.
• Access Criteria: Data will be uploaded to the NIMH Data Archive and subject to their access policies. Code will be uploaded to GitHub and/or Open Science Foundation (osf.io) and will be publicly available.

Locations

US (2)