Test of Target Engagement of Ambiguity Aversion

NCT06962527 | Recruiting

• 1 other identifier: K23MH136421
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Beck Hopelessness Scale-4 (BHS-4)

  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.

  1 hour

• Behavioral ambiguity aversion

  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).

  1 hour

• Event-related potential responses to ambiguous choices

  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.

  1 hour

Study Arms (2)

Uncertainty-focused single session intervention

EXPERIMENTAL

This is a digital, self-guided SSI that teaches adults about tolerating and embracing uncertainty in their life. The SSI is based on five elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from peers describing beliefs that people's thoughts, feelings, and behaviors are malleable, given the brain's capacity for change; 3. Strategies (from cognitive-behavioral therapy) for applying these principles to participants' lives; 4. Further vignettes by peers describing times when they tolerated or embraced uncertainty; 5. An exercise wherein participants provide advice to fictional peers, using newly-gleaned information about uncertainty,

Behavioral: Uncertainty-focused single session intervention

Maintaining a healthy lifestyle single session intervention

PLACEBO COMPARATOR

This is a digital, self-guided SSI that teaches adults about the benefits of maintaining a healthy lifestyle (e.g., proper sleep, diet, exercise), emphasizing recommendations by various bodies (e.g., American Medical Association). It is structurally similar to the uncertainty-focused SSI but is designed to mimic what people would receive in their annual physical with a primary care physician. The goals of this intervention is to encourage participants to identify aspects of a healthy lifestyle, and steps they could take towards a healthier lifestyle. This SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program, reading and writing exercises, and vignettes from peers.

Behavioral: Maintaining a healthy lifestyle single session intervention

Interventions

Uncertainty-focused single session intervention BEHAVIORAL

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

Also known as: Uncertainty-focused SSI

Uncertainty-focused single session intervention

Maintaining a healthy lifestyle single session intervention BEHAVIORAL

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

Also known as: Maintaining a healthy lifestyle SSI

Maintaining a healthy lifestyle single session intervention

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.).

Sponsors & Collaborators

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

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Brent I Rappaport, Ph.D.

CONTACT

(312) 585-6603; decisionmaking@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: May 8, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Anonymized data and code will be made publicly available upon publication of trial results, which is anticipated to be in 2030.
• Access Criteria: Data will be posted of the NIMH Data Archive (NDA).

Locations

US (1)