An interventional study of Shock or startle device in Anxiety and Healthy Volunteers, sponsored by National Institute of Mental Health (NIMH). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by National Institute of Mental Health (NIMH) · Not applicable, Interventional, and Basic science
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.
Study Description:
This study s goal is to identify parameters of interest in decision making in the context of anxiety disorders, using theoretical models in healthy volunteers (HV) and anxiety patients (AD). Participants are asked to complete a decision-making task, namely the Multi-armed Bandit Task.
The study will be conducted in the clinic. Participants (HV and AD) are asked to fill out questionnaires and complete the Multi-armed Bandit Task. An electric shock is used as the aversive stimulus. Monetary reward is used as the reward stimulus. Additionally, physiological signals (Heart rate, skin conductance activity, startle) are collected during the course of the task. In addition, in a pilot study, participants startle responses for varying shock parameters are recorded and analyzed.
Objectives:
The primary objective of this study is to use theoretical models in healthy volunteers (HV) and patients with an anxiety disorder (AD) to better understand how changes in anxiety are associated with changes in decision making. In addition, this study will ascertain whether decision making parameters correlate with certain behavioral measures such as trait and state anxiety using (i) questionnaires, (ii) physiological measures.
Endpoints:
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups. The parameters of interest include: 1) Learning Rate, 2) Exploration parameter, 3) Discount rate, 4) Loss aversion, 5) Inverse Temperature.
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's enrollment of 51 is below the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →National Institute of Mental Health (NIMH) is the lead sponsor of 359 studies on the registry; 46 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Participants with anxiety completed computer tasks. They were given different choices and had to make choice(s). The objective was to find the optimal choice by sampling through the choices. They received an unpleasant or pleasant stimulus based on their choice(s). They repeated these tasks many times.
Device: Shock or startle device
Healthy volunteers completed computer tasks. They were given different choices and had to make choice(s). The objective was to find the optimal choice by sampling through the choices. They received an unpleasant or pleasant stimulus based on their choice(s). They repeated these tasks many times.
Device: Shock or startle device
Shock and startle devices were used as aversive stimulus (shock and startle)
Difference in Learning Rate
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 learning rate was analyzed using a 2-way ANOVA with condition and population. The learning rate (α) range between 0 and 1. The higher the value, the faster rate of learning. However, a higher learning rate may also result in lower generalization capability.
Time frame: End of experiment (3-4 hours in a single day visit)
| Milestone | Anxiety Patient | Healthy Volunteer |
|---|---|---|
| Started | 20 | 31 |
| Completed | 20 | 31 |
| Not completed | 0 | 0 |
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 learning rate was analyzed using a 2-way ANOVA with condition and population. The learning rate (α) range between 0 and 1. The higher the value, the faster rate of learning. However, a higher learning rate may also result in lower generalization capability.
| unitless | Anxiety Patient | Healthy Volunteer |
|---|---|---|
| Difference in Learning Rate | 0.009 ± 0.0315 | 0.0058 ± 0.037 |
Collected over One day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anxiety Patient | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Healthy Volunteer | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Categorical(Participants) | Anxiety Patient | Healthy Volunteer | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 31 | 51 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Anxiety Patient | Healthy Volunteer | Total |
|---|---|---|---|
| Female | 19 | 18 | 37 |
| Male | 1 | 13 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Anxiety Patient | Healthy Volunteer | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 1 | 6 |
| Not Hispanic or Latino | 15 | 30 | 45 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Anxiety Patient | Healthy Volunteer | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 8 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 12 | 17 | 29 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 1 | 0 | 1 |
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Plan to share: No — De-identified data will be shared to a repository. Identified individual participant data will not be shared.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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National Institute of Mental Health (NIMH)