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Recruiting NCT06962527

Test of Target Engagement of Ambiguity Aversion

No phase Interventional Intolerance of Uncertainty Anxiety Intolerance of Uncertainty; Anxiety Depression, Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Uncertainty-focused single session intervention, Maintaining a healthy lifestyle single session intervention.
Who it may be relevant to
Registry conditions: Intolerance of Uncertainty, Anxiety, Intolerance of Uncertainty; Anxiety, Depression, Anxiety. Basic parameters: 25 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral Uncertainty-focused single session intervention
    Digitally/computer administered 30-minute self-guided intervention for adults ages 25-60
  • Behavioral Maintaining a healthy lifestyle single session intervention
    Digitally/computer administered 30-minute self-guided intervention for adults ages 25-60

Primary outcome measures

  • Beck Hopelessness Scale-4 (BHS-4) [Time frame: 1 hour]
  • Behavioral ambiguity aversion [Time frame: 1 hour]
  • Event-related potential responses to ambiguous choices [Time frame: 1 hour]

Eligibility criteria

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Northwestern University — Chicago

Identifiers

NCT: NCT06962527 · K23MH136421

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗