AnxietyNCT07203027
Quantifying Multi-step Avoidance in Anxiety
A study testing Behavioral Tasks with imaging in people with Anxiety and Anxiety Disorders, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Anxiety Disorders
- What is being tested?
- Behavioral Tasks with imaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2027to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- Severe risk of suicide, or
- Recent (<3 months) changes in psychotropic medicine or psychotherapy treatment,
- Ineligible at the PI's discretion, are excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Emory College
Atlanta, Georgia, 30322
Facility for Education and Research in Neuroscience (FERN)
Atlanta, Georgia, 30322
About this study
Official title: Quantifying Neural Signatures of Multi-step Avoidance Behavior in Anxiety
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.
Read the detailed description
Current learning theories of anxiety propose that disrupted fear learning underlie anxiety disorders. This suggests that treatments like exposure therapy work by changing learned threat values. However, empirical data does not support these models where changes in fear conditioning lead to symptom changes and later reductions of avoidance behavior. Instead, recent findings suggest that avoidance behavior can be a mechanism on its own, and reductions in avoidance behavior both precede and predict improvements in anxiety symptoms. To target avoidance, a working theory of the processes underlying avoidance behavior is needed. Recently, Markov Decision Process (MDP) models have been used to measure threat expectancy, which has the advantage of capturing the difference between avoidance and fear learning as mechanisms in anxiety disorders. Initial MDP models that demonstrate the rise of avoidance behavior show promise; however, additional non-behavioral information is needed to fit these models in humans.
The researcher's main hypothesis is that MDP models, augmented with decoded neural signals of threat imminence, can characterize and modify anxiety disorder-related avoidance behavior in and outside of the laboratory.
Aim 1: Adults unselected for psychopathology (120, assessed twice): develop a brain signature of threat imminence (from a predictive model independently trained on fMRI data from other threat imminence tasks) and combine with task behavior to create an MDP model of avoidance behavior.
Aims 2 and 3: A separate set of participants with clinical anxiety and maladaptive avoidance (N=163, assessed four times) will complete an MDP-based learning task assessing avoidance during fMRI scanning and quantify differences in MDP-modeled behavior and test if the magnitude of these task-based differences predicts between-and within-person differences in the severity of real-world avoidance behavior.
Multivariate predictors of functional magnetic resonance imaging (fMRI) data can decode latent values and enhance the computational fit of the MDP models. To identify these latent values, previously validated neural signatures of a threat-imminence model will be used. In the threat-imminence model, the same brain regions (e.g., amygdala, vmPFC), but different ensembles and neural populations, are involved in different stages of threat imminence, and these patterns do not differ between humans with different levels of clinical anxiety, allowing for a neurobiologically supported approach to creating latent values of threat. Therefore, researchers aim to use MDP models, augmented with decoded neural signals of threat imminence, to characterize and support a new mechanism (avoidance behavior) of symptom change in anxiety and modify anxiety disorder-related avoidance behavior.
- Conditions
- Anxiety, Anxiety Disorders
- Being tested
- Behavioral Tasks with imaging
- Keywords
- Avoidance behavior, Fear learning
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Tasks with imagingBehavioural
Also called Investigational
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Tasks with imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 1, week 2, week 3, and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study startJan 2027 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (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.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Vanessa M. Brown, Emory University
- Investigators
- Vanessa M Brown, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203027
- Sponsor's protocol ID
- STUDY00009403
- Other IDs
- 1R01MH139780, 2025P010991
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers will share individual de-identified data, including demographic, clinical, behavioral performance on tasks, naturalistic self-reports of avoidance behavior, GPS and accelerometer data, and structural and functional MRI data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Neural Signatures of Multi-step Avoidance Behavior in Anxiety
- ClinicalTrials.gov ID
- NCT07203027
- Acronym / sponsor ID
- STUDY00009403
- Conditions
- Anxiety, Anxiety Disorders
- Keywords
- Avoidance behavior, Fear learning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 2 Oct 2025 (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.
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.
Detailed description
Current learning theories of anxiety propose that disrupted fear learning underlie anxiety disorders. This suggests that treatments like exposure therapy work by changing learned threat values. However, empirical data does not support these models where changes in fear conditioning lead to symptom changes and later reductions of avoidance behavior. Instead, recent findings suggest that avoidance behavior can be a mechanism on its own, and reductions in avoidance behavior both precede and predict improvements in anxiety symptoms. To target avoidance, a working theory of the processes underlying avoidance behavior is needed. Recently, Markov Decision Process (MDP) models have been used to measure threat expectancy, which has the advantage of capturing the difference between avoidance and fear learning as mechanisms in anxiety disorders. Initial MDP models that demonstrate the rise of avoidance behavior show promise; however, additional non-behavioral information is needed to fit these models in humans.
The researcher's main hypothesis is that MDP models, augmented with decoded neural signals of threat imminence, can characterize and modify anxiety disorder-related avoidance behavior in and outside of the laboratory.
Aim 1: Adults unselected for psychopathology (120, assessed twice): develop a brain signature of threat imminence (from a predictive model independently trained on fMRI data from other threat imminence tasks) and combine with task behavior to create an MDP model of avoidance behavior.
Aims 2 and 3: A separate set of participants with clinical anxiety and maladaptive avoidance (N=163, assessed four times) will complete an MDP-based learning task assessing avoidance during fMRI scanning and quantify differences in MDP-modeled behavior and test if the magnitude of these task-based differences predicts between-and within-person differences in the severity of real-world avoidance behavior.
Multivariate predictors of functional magnetic resonance imaging (fMRI) data can decode latent values and enhance the computational fit of the MDP models. To identify these latent values, previously validated neural signatures of a threat-imminence model will be used. In the threat-imminence model, the same brain regions (e.g., amygdala, vmPFC), but different ensembles and neural populations, are involved in different stages of threat imminence, and these patterns do not differ between humans with different levels of clinical anxiety, allowing for a neurobiologically supported approach to creating latent values of threat. Therefore, researchers aim to use MDP models, augmented with decoded neural signals of threat imminence, to characterize and support a new mechanism (avoidance behavior) of symptom change in anxiety and modify anxiety disorder-related avoidance behavior.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anxiety and impairing levels of avoidance | Experimental | Behavioral: Behavioral Tasks with imagingParticipants 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. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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,
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 |
|---|---|---|
| Behavioral Tasks with imagingAlso: InvestigationalParticipants 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. | Behavioural | Anxiety and impairing levels of avoidance |
Primary outcome
Ecological momentary assessment (EMA)
Time frame: Baseline, week 1, week 2, week 3, and week 4
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.
Avoidance Severity Based on Location Entropy
Time frame: Baseline, week 1, week 2, week 3, and week 4
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.
Change in Location Entropy
Time frame: Baseline, week 1, week 2, week 3, and week 4
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Researchers will share individual de-identified data, including demographic, clinical, behavioral performance on tasks, naturalistic self-reports of avoidance behavior, GPS and accelerometer data, and structural and functional MRI data.
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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.
Vanessa M Brown, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Tasks with imaging in people with Anxiety and Anxiety Disorders, run by Emory University at 2 sites 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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa M. Brown, PhD (404-727-5454, vanessa.m.brown@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ecological momentary assessment (EMA) (time frame: Baseline, week 1, week 2, week 3, and week 4). The study lists 3 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 5 Oct 2026.