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NCT Number: NCT06962527

Test of Target Engagement of Ambiguity Aversion

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.

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Key information

Conditions

Intolerance of Uncertainty Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Intolerance of Uncertainty; Anxiety Mental Disorders

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Brent I Rappaport, Ph.D.

CONTACT

[email protected]

(312) 585-6603‬

Brent I Rappaport, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Uncertainty-focused single session intervention

Behavioral

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

Other names: Uncertainty-focused SSI

Maintaining a healthy lifestyle single session intervention

Behavioral

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

Other names: Maintaining a healthy lifestyle SSI

Primary outcomes

  1. Beck Hopelessness Scale-4 (BHS-4)

    Time frame: 1 hour

    The 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.

  2. Behavioral ambiguity aversion

    Time frame: 1 hour

    Computational 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).

  3. Event-related potential responses to ambiguous choices

    Time frame: 1 hour

    From 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brent I Rappaport, Ph.D.

CONTACT

[email protected]

(312) 585-6603

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 8, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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