Test of Target Engagement of Ambiguity Aversion

Northwestern University

Status: Enrolling

Conditions: Depression, Anxiety; Intolerance of Uncertainty; Anxiety; Anxiety; Intolerance of Uncertainty

Treatments: Behavioral: Maintaining a healthy lifestyle single session intervention; Behavioral: Uncertainty-focused single session intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06962527

K23MH136421 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Uncertainty-focused single session intervention

Experimental group

Description:

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,

Treatment:

Behavioral: Uncertainty-focused single session intervention

Maintaining a healthy lifestyle single session intervention

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Maintaining a healthy lifestyle single session intervention