Test of Target Engagement of Ambiguity Aversion

NCT ID: NCT06962527

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Uncertainty-focused single session intervention

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,

Group Type EXPERIMENTAL

Uncertainty-focused single session intervention

Intervention Type BEHAVIORAL

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

Maintaining a healthy lifestyle single session intervention

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.

Group Type PLACEBO_COMPARATOR

Maintaining a healthy lifestyle single session intervention

Intervention Type BEHAVIORAL

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

Interventions

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Uncertainty-focused single session intervention

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

Intervention Type BEHAVIORAL

Maintaining a healthy lifestyle single session intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Uncertainty-focused SSI Maintaining a healthy lifestyle SSI

Eligibility Criteria

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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.).
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Brent Rappaport

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brent I Rappaport, Ph.D.

Role: CONTACT

(312) 585-6603

Facility Contacts

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Brent I Rappaport, Ph.D.

Role: primary

(312) 585-6603‬

Other Identifiers

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K23MH136421

Identifier Type: NIH

Identifier Source: org_study_id

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