Intolerance of UncertaintyNCT06962527
Test of Target Engagement of Ambiguity Aversion
A study testing Uncertainty-focused single session intervention and Maintaining a healthy lifestyle single session intervention in people with Intolerance of Uncertainty and Anxiety, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intolerance of Uncertainty, Anxiety, Intolerance of Uncertainty; Anxiety
- What is being tested?
- Uncertainty-focused single session intervention and Maintaining a healthy lifestyle single session intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Brent I Rappaport, Ph.D., (312) 585-6603, decisionmaking@northwestern.edu
Brent I Rappaport, Ph.D.
About this study
Official title: Computational Modeling of Ambiguity Aversion in Internalizing Disorders: Neural and Behavioral Markers, and a Test of Target Engagement
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.
Read the 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.
- Conditions
- Intolerance of Uncertainty, Anxiety, Intolerance of Uncertainty; Anxiety, Depression, Anxiety
- Being tested
- Uncertainty-focused single session intervention, Maintaining a healthy lifestyle single session intervention
- Keywords
- Ambiguity aversion, Intolerance of uncertainty, Computational modeling, EEG/ERP
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncertainty-focused single session interventionBehavioural
Also called Uncertainty-focused SSI
Digitally/computer administered 30-minute self-guided intervention for adults ages 25-60
Maintaining a healthy lifestyle single session interventionBehavioural
Also called Maintaining a healthy lifestyle SSI
Digitally/computer administered 30-minute self-guided intervention for adults ages 25-60
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: 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. Receives: Behavioral: Maintaining a healthy lifestyle single session intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start7 Jul 2025
- Primary completion1 Jul 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intolerance of UncertaintyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Brent Rappaport, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962527
- Sponsor's protocol ID
- K23MH136421
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available once they are anonymized and all the planned analyses have been completed by the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Modeling of Ambiguity Aversion in Internalizing Disorders: Neural and Behavioral Markers, and a Test of Target Engagement
- ClinicalTrials.gov ID
- NCT06962527
- Acronym / sponsor ID
- K23MH136421
- Conditions
- Intolerance of Uncertainty, Anxiety, Intolerance of Uncertainty; Anxiety, Depression, Anxiety
- Keywords
- Ambiguity aversion, Intolerance of uncertainty, Computational modeling, EEG/ERP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncertainty-focused single session intervention | Experimental | Behavioral: Uncertainty-focused single session interventionThis 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, |
| Maintaining a healthy lifestyle single session intervention | Placebo comparator | Behavioral: Maintaining a healthy lifestyle single session interventionThis 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uncertainty-focused single session interventionAlso: Uncertainty-focused SSIDigitally/computer administered 30-minute self-guided intervention for adults ages 25-60 | Behavioural | Uncertainty-focused single session intervention |
| Maintaining a healthy lifestyle single session interventionAlso: Maintaining a healthy lifestyle SSIDigitally/computer administered 30-minute self-guided intervention for adults ages 25-60 | Behavioural | Maintaining a healthy lifestyle single session intervention |
Primary outcome
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes. Data will be made available once they are anonymized and all the planned analyses have been completed by the investigators.
Related trials for Intolerance of Uncertainty
Not yet recruiting
Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty Versus Applied Relaxation
Mental Disorders, Mood Disorders
Active, not recruiting
Effects and Mechanisms of Change of Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder
Generalized Anxiety Disorder
Not yet recruiting
The Impact of a Web-based Empowerment Program on Intolerance of Uncertainty and Maintenance Burden.
Intolerance of Uncertainty, Caregiving Burden
Enrolling by invitationObservational study
Measurement of the Intolerance to Uncertainty in Osteopaths
Cognition of Osteopath
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncertainty-focused single session intervention and Maintaining a healthy lifestyle single session intervention in people with Intolerance of Uncertainty and Anxiety, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brent I Rappaport, Ph.D. ((312) 585-6603, decisionmaking@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Hopelessness Scale-4 (BHS-4) (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.