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Test of Target Engagement of Ambiguity Aversion

Computational Modeling of Ambiguity Aversion in Internalizing Disorders: Neural and Behavioral Markers, and a Test of Target Engagement

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06962527
Enrollment
140
Registered
2025-05-08
Start date
2025-07-07
Completion date
2029-12-31
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Anxiety, Intolerance of Uncertainty, Intolerance of Uncertainty; Anxiety

Keywords

Ambiguity aversion, Intolerance of uncertainty, Computational modeling, EEG/ERP

Brief summary

The present work aims to test whether a single session intervention alters ambiguity aversion, both in terms of people's decision making and their brain responses to ambiguous choices.

Detailed description

In this trial, participants will be randomized to one of two single session interventions (SSI). They will complete a decision making task before and after the SSI to measure their behavioral and brain responses to ambiguity, all on the same day. They will also complete a brief measure of hopelessness before and after the SSI. The main analysis will compare changes in ambiguity aversion before and after the interventions. Participants will also be asked to complete questionnaires before completing the task and SSI. The questionnaires will be about the participant's emotions and symptoms of depression and anxiety, personality, and avoidance/tolerance of uncertainty.

Interventions

BEHAVIORALUncertainty-focused single session intervention

Digitally/computer administered 30-minute self-guided intervention for adults ages 25-60

BEHAVIORALMaintaining a healthy lifestyle single session intervention

Digitally/computer administered 30-minute self-guided intervention for adults ages 25-60

Sponsors

Northwestern University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Participants will be aware that there is one other arm of the study to which other participants are randomized, but they will not be aware of what this other arm entails. Additionally, the intervention will be administered digitally, without a care provider, and outcome measures will be self-administered, so there is no potential for evaluator bias.

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Ages 25 to 60 2. Right-handed 3. Ability to read and write English 4. Capacity to provide informed consent 5. Intolerance of uncertainty score ≥ -0.5 standard deviation below the mean (31st percentile)

Exclusion criteria

1. Personal history of psychosis, mania, or hypomania 2. Personal history of autism spectrum disorder 3. IQ \< 80 as determined by the Wechsler Test of Adult Reading 4. Head injury with greater than 120 seconds loss of consciousness 5. Neurological condition (e.g., epilepsy, Parkinson's, cerebral palsy, history of stroke) 6. Currently pregnant 7. Use of any implanted electrical device (e.g., pacemaker, spinal stimulator, vagal nerve stimulator, Inspire sleep apnea device, etc.).

Design outcomes

Primary

MeasureTime frameDescription
Beck Hopelessness Scale-4 (BHS-4)1 hourThe BHS-482 is a four-item self-report scale that will be used to assess hopelessness before and after the experimental intervention (scale assesses hopelessness "right now, in this moment") to determine whether the intervention was effective in eliciting change in a clinically meaningful construct. It has good psychometric properties. Participants will complete the Beck Hopelessness Scale (BHS-4) before and after the intervention as a manipulation check that the single session intervention (SSI) "worked" in the event that the other primary outcomes exhibit resistance to change.
Behavioral ambiguity aversion1 hourComputational modeling will be used to extract two parameters indicative of behavioral ambiguity aversion (AA) from a risk and ambiguity task completed once before and once after the intervention. This results in two variables per participant: one which indicates categorical AA (i.e., their tendency to choose the unambiguous choice regardless of the amount of ambiguity present) and one which indicates continuous AA (i.e., how the amount of ambiguity influences people's choice).
Event-related potential responses to ambiguous choices1 hourFrom EEG data collected during the risk and ambiguity task, event-related potentials (ERPs)-time-locked electroencephalogram signals with millisecond resolution-will be extracted to yield one variable per participant indicating mean brain activity to ambiguous choices. Pilot data and small prior studies have consistently found an attenuated P300-like component (albeit later than usual, around 350-500ms) to ambiguous relative to unambiguous choices similar to those on this task.

Countries

United States

Contacts

CONTACTBrent I Rappaport, Ph.D.
decisionmaking@northwestern.edu(312) 585-6603

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026