NCT05092971

Identifying Decision Making Parameters in Healthy Volunteers and Anxiety Patients

Completed NA Results posted Last updated 22 May 2024

What this trial tests

NA trial testing Shock or startle device in Anxiety in 51 participants. Completed in 28 July 2022.

Timeline

3 March 2022

Primary endpoint
28 July 2022

28 July 2022

Quick facts

Lead sponsor	National Institute of Mental Health (NIMH)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	51
Start date	3 March 2022
Primary completion	28 July 2022
Estimated completion	28 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Shock or startle device

Conditions studied

• Anxiety — all drugs for Anxiety →
• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

National Institute of Mental Health (NIMH)

Who can join

Adults 18 to 50, any sex, with Anxiety or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference in Learning Rate Primary · End of experiment (3-4 hours in a single day visit)

Learning rate is a hyperparameter that quantifies the degree to which subjects update their beliefs in response to feedback. The outcome examined the difference in learning rate between experimental manipulation (condition) and population (healthy and anxiety subjects). During the multi-arm bandit task, participants choose from a set of choices and update their belief of the value of the choices based on prior choices with some choices having a higher probability of shock (punishment) than reward. The changes in learning rate were measured using the learning rate algorithm. The difference in

Group	Value	95% CI
Anxiety Patient	0.009	± 0.0315
Healthy Volunteer	0.0058	± 0.037

Sponsor's own description

Background:

Research has shown that anxiety affects more than feelings. It also affects behavior. Researchers want to learn how the brain and body respond to unexpected threats. They want to see if probable pleasant or unpleasant events change decisions.

Objective:

To better understand how changes in anxiety are associated with changes in decision-making.

Eligibility:

Adults aged 18-50 with generalized anxiety disorder, seasonal affective disorder, or panic disorder. Healthy volunteers are also needed.

Design:

Participants will be screened under protocol #01-M-0254.

Participants will complete surveys about their anxiety, risk-taking, and curiosity.

Participants will complete a computer task. They will be given different choices. They will make a choice. They will receive an unpleasant or pleasant stimulus based on their choice. They will repeat this task many times.

Most participants will do the task in the clinic. The unpleasant stimulus will be electric shock and acoustic startle. They will receive electric shocks through electrodes placed on their arm or fingers. They may hear loud noises through headphones. Their eyeblinks will be recorded with electrodes placed under their eye. Their heart rate and skin conductance activity will be collected with electrodes as well.

Some healthy volunteers will do the task during a functional magnetic resonance imaging scan. They will lie on a table that slides in and out of a scanner. A coil will be placed over their head. The unpleasant stimulus will be electric shock, given as stated above. The scanner will record their brain activity. Their breathing and pulse rate will be recorded as well.

Participation will last for 3-4 hours.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.