AnxietyNCT05092971
Identifying Decision Making Parameters in Healthy Volunteers and Anxiety Patients
A study testing Shock or startle device in people with Anxiety and Healthy Volunteers, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Healthy Volunteers
- What is being tested?
- Shock or startle device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Male or female, aged 18-50, inclusive
- Patients only: Primary Diagnostic and Statistical Manual (DSM) 5 diagnoses of an anxiety disorder (GAD, social anxiety disorder (SAD), panic disorder)
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Non-English speaking individual
- Pregnancy or positive pregnancy test
- Any significant medical or neurological problems as determined by investigators (e.g.cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
- Current or past serious mental disorders (e.g., bipolar or psychotic disorders) (except for anxiety and depressive disorders in patients)
- Current alcohol or substance use disorder
Show all 11Show fewer
- History of moderate or severe alcohol or substance use disorder within one year prior to screening
- Current or past significant organic central nervous system disorders as determined by investigators, including but not limited to seizure disorder or neurological symptoms of the wrist and arm (e.g., carpal tunnel syndrome) for shocks to be delivered on affected arm.
- Positive urine toxicology screen at screening visit under 01-M-0254
- Employees of National Institute of Mental Health (NIMH) or an immediate family member of a NIMH employee.
- Healthy volunteers only: Current DSM-5 disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Identifying Decision Making Parameters in Healthy Volunteers (HV) and Anxiety Patients (AD)
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.
Read more
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.
Read the detailed description
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:
- Questionnaire scores
- Startle
- Skin conductance
- Conditions
- Anxiety, Healthy Volunteers
- Being tested
- Shock or startle device
- Keywords
- functional magnetic resonance imaging (fMRI), multi-arm bandit task, anxiety volunteers, Healthy Volunteers
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock or startle deviceDevice
Shock and startle devices were used as aversive stimulus (shock and startle)
| Study group | Role | What they receive |
|---|---|---|
| Anxiety patient | Experimental | 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. Receives: Device: Shock or startle device |
| Healthy volunteer | Experimental | 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. Receives: Device: Shock or startle device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of experiment (3-4 hours in a single day visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start3 Mar 2022
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Maryland Pao, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092971
- Sponsor's protocol ID
- 10000378
- Other IDs
- 000378-M
- Status last verified
- 28 Jul 2022
- First submitted
- 23 Oct 2021
- Last updated
- 22 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified data will be shared to a repository. Identified individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Decision Making Parameters in Healthy Volunteers (HV) and Anxiety Patients (AD)
- ClinicalTrials.gov ID
- NCT05092971
- Acronym / sponsor ID
- 10000378
- Conditions
- Anxiety, Healthy Volunteers
- Keywords
- functional magnetic resonance imaging (fMRI), multi-arm bandit task, anxiety volunteers, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 22 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Questionnaire scores
- Startle
- Skin conductance
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxiety patient | Experimental | Device: Shock or startle deviceParticipants 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. |
| Healthy volunteer | Experimental | Device: Shock or startle deviceHealthy 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Male or female, aged 18-50, inclusive
- Patients only: Primary Diagnostic and Statistical Manual (DSM) 5 diagnoses of an anxiety disorder (GAD, social anxiety disorder (SAD), panic disorder)
Key exclusion criteria (11 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Non-English speaking individual
- Pregnancy or positive pregnancy test
- Any significant medical or neurological problems as determined by investigators (e.g.cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
- Current or past serious mental disorders (e.g., bipolar or psychotic disorders) (except for anxiety and depressive disorders in patients)
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 |
|---|---|---|
| Shock or startle deviceShock and startle devices were used as aversive stimulus (shock and startle) | Device | Anxiety patient, Healthy volunteer |
Primary outcome
Difference in Learning Rate
Time frame: 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 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified data will be shared to a repository. Identified individual participant data will not be shared.
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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. This study is not recruiting at the moment.
Maryland Pao, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shock or startle device in people with Anxiety and Healthy Volunteers, run by National Institute of Mental Health (NIMH) 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 22 May 2024. 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. 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?
Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Learning Rate (time frame: End of experiment (3-4 hours in a single day visit)). 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 22 May 2024.