Anxiety DisordersNCT03033056
Neurobiology of Generalized Fear-Conditioning & Avoidance in Anxiety Disorders
An observational study of Anxiety Disorders, run by University of Minnesota at 1 site in United States.
Trial summary
Anxiety disorders are among the most prevalent, costly, and disabling mental illnesses. One central, yet largely understudied, abnormality in anxiety disorders is the heightened tendency to display fear and avoidance in reaction to benign or safe events that resemble feared situations. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Test of fear conditioning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Male and female adults presenting with anxiety symptoms at the Anxiety Disorders Clinic in the Department of Psychiatry at U of MN, as well as demographically matched healthy comparisons
Who may be able to join
- Diagnosis: No psychiatric diagnosis is required, but recruitment will be guided by the goal of attaining a sample with wide-ranging levels of both anxiety symptom severity and individual differences in anxiety-related states and traits.
- Caffeine and tobacco use: Participants will abstain from caffeine and tobacco one hour preceding testing
Who cannot join
- Psychiatric health: Current or past history of any psychotic disorder, bipolar disorder, delirium, dementia, amnestic disorder, or mental retardation; comorbid depression if accompanied by current, significant suicide risk; substance use disorder presently or for the six months preceding testing.
- Current use of any medication that alters central nervous system function including antidepressants, benzodiazepines, anti-psychotics, mood stabilizers,anti-parkinsonian agents, anti-convulsants, sleep medications, pain medications, and anti-hypertensives.
- Medical health: Current or past medical illnesses which in the investigator's opinion may confound study results, or place the participant at risk.
- Pregnancy status: Females who are, or may be, pregnant. Recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of MInnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Neurobiology of Generalized Fear-Conditioning & Avoidance in Anxiety Disorders (Community Anxiety Response Study)
Anxiety disorders are among the most prevalent, costly, and disabling mental illnesses. One central, yet largely understudied, abnormality in anxiety disorders is the heightened tendency to display fear and avoidance in reaction to benign or safe events that resemble feared situations. The current project maps brain circuits associated with this abnormality in order to contribute to future brain-based diagnosis and treatments for clinical anxiety.
Read the detailed description
The objective of this project is to neurally, behaviorally, psychologically, and clinically characterize fundamental Pavlovian and instrumental dimensions of potential threat through which emotional and behavioral responses to threat cues generalize to resembling, safe stimuli. Such generalization is aligned with the potential threat construct due to the threat ambiguity, or uncertain threat value, inherent in these safe 'generalization' stimuli. The Pavlovian dimension of interest is generalization of conditioned fear: a fundamental Pavlovian process through which fear transfers, or generalizes, to safe stimuli resembling a conditioned threat-cue (CS+). The targeted instrumental dimension is generalized avoidance: active decisions to withdraw from safe stimuli resembling the CS+ that are motivationally prompted by Pavlovian generalization. Given lab-based findings have linked heightened Pavlovian generalization to a variety of traditional anxiety disorders, overgeneralization represents a promising dimension of potential threat with relevance across traditional anxiety disorders. One central aspect of this project is testing personality and psychiatric factors (e.g., trait fear, internalizing, externalizing) that may account for the relevance of generalization and its neurobiology across traditional anxiety disorders. A second key aspect, is studying neural processes by which Pavlovian generalization evokes instrumental generalized avoidance of benign stimuli (resembling danger cues), which, when excessive, is likely to impair day-to-day functioning in anxiety patients. Unfortunately, human fear-conditioning experiments in clinical samples, have focused almost exclusively on passive-emotional, Pavlovian conditioning, to the virtual exclusion of studying active-behavioral, instrumental avoidance. The current neuroimaging project fills this gap by applying a novel Pavlovian-instrumental generalization paradigm to neurally and behaviorally elucidate Pavlovian processes leading to generalized instrumental avoidance. Personality moderators (e.g., dispositional resilience) of relations between Pavlovian and instrumental generalization will also be examined. The studied adult samples will display a wide range of symptom severity across traditional anxiety disorders and will include anxiety-clinic patients and healthy comparisons (N=159). Central goals of this proposal include: 1) elucidating the neurobiology of Pavlovian and instrumental generalization and their interaction, 2) testing relations between neural substrates of Pavlovian and instrumental generalization and broad psychiatric dysfunction (Aims2-3); and 3) assessing the degree to which relations between these dimensions of generalization and broad dysfunction are driven by psychometrically validated personality traits relevant across traditional anxiety disorders. This third and final goal is critical to the project, because individual difference measures capturing empirically-validated psychological constructs will likely track relations between fundamental conditioning processes (e.g., generalization) and general dysfunction, better than traditional, polythetic, diagnostic entities, that, by and large, do not reflect any single coherent psychological process.
- Conditions
- Anxiety Disorders
- Being tested
- Test of fear conditioning
- Keywords
- fear-conditioning, behavioral avoidance, anxiety disorders, fMRI
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of fear conditioningBehavioural
Behavioral and brain correlates of conditioned fear generalization and avoidance will be assessed using fMRI and related to levels of anxiety related psychopathology.
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Clinic Patients | Adult males and females being treated at the anxiety disorders clinic at the University of Minnesota predominantly for clinical anxiety. Receives: Behavioral: Test of fear conditioning | |
| Healthy Comparisons | Sex, age, and socioeconomically matched healthy controls Receives: Behavioral: Test of fear conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging
Blood oxygenation level dependent responses elicited during the fear conditioning paradigm
Measured: Years 1-4
Secondary outcomes (1)
Behavioral measures
Online behavioral responses elicited during the fear conditioning paradigm
Measured: Years 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start17 Jul 2017
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shmuel Lissek, PhD, Principal investigator, U of MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033056
- Sponsor's protocol ID
- 1610M96641
- Status last verified
- Mar 2022
- First submitted
- 24 Jan 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiology of Generalized Fear-Conditioning & Avoidance in Anxiety Disorders (Community Anxiety Response Study)
- ClinicalTrials.gov ID
- NCT03033056
- Acronym / sponsor ID
- 1610M96641
- Conditions
- Anxiety Disorders
- Keywords
- fear-conditioning, behavioral avoidance, anxiety disorders, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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.
Anxiety disorders are among the most prevalent, costly, and disabling mental illnesses. One central, yet largely understudied, abnormality in anxiety disorders is the heightened tendency to display fear and avoidance in reaction to benign or safe events that resemble feared situations. The current project maps brain circuits associated with this abnormality in order to contribute to future brain-based diagnosis and treatments for clinical anxiety.
Detailed description
The objective of this project is to neurally, behaviorally, psychologically, and clinically characterize fundamental Pavlovian and instrumental dimensions of potential threat through which emotional and behavioral responses to threat cues generalize to resembling, safe stimuli. Such generalization is aligned with the potential threat construct due to the threat ambiguity, or uncertain threat value, inherent in these safe 'generalization' stimuli. The Pavlovian dimension of interest is generalization of conditioned fear: a fundamental Pavlovian process through which fear transfers, or generalizes, to safe stimuli resembling a conditioned threat-cue (CS+). The targeted instrumental dimension is generalized avoidance: active decisions to withdraw from safe stimuli resembling the CS+ that are motivationally prompted by Pavlovian generalization. Given lab-based findings have linked heightened Pavlovian generalization to a variety of traditional anxiety disorders, overgeneralization represents a promising dimension of potential threat with relevance across traditional anxiety disorders. One central aspect of this project is testing personality and psychiatric factors (e.g., trait fear, internalizing, externalizing) that may account for the relevance of generalization and its neurobiology across traditional anxiety disorders. A second key aspect, is studying neural processes by which Pavlovian generalization evokes instrumental generalized avoidance of benign stimuli (resembling danger cues), which, when excessive, is likely to impair day-to-day functioning in anxiety patients. Unfortunately, human fear-conditioning experiments in clinical samples, have focused almost exclusively on passive-emotional, Pavlovian conditioning, to the virtual exclusion of studying active-behavioral, instrumental avoidance. The current neuroimaging project fills this gap by applying a novel Pavlovian-instrumental generalization paradigm to neurally and behaviorally elucidate Pavlovian processes leading to generalized instrumental avoidance. Personality moderators (e.g., dispositional resilience) of relations between Pavlovian and instrumental generalization will also be examined. The studied adult samples will display a wide range of symptom severity across traditional anxiety disorders and will include anxiety-clinic patients and healthy comparisons (N=159). Central goals of this proposal include: 1) elucidating the neurobiology of Pavlovian and instrumental generalization and their interaction, 2) testing relations between neural substrates of Pavlovian and instrumental generalization and broad psychiatric dysfunction (Aims2-3); and 3) assessing the degree to which relations between these dimensions of generalization and broad dysfunction are driven by psychometrically validated personality traits relevant across traditional anxiety disorders. This third and final goal is critical to the project, because individual difference measures capturing empirically-validated psychological constructs will likely track relations between fundamental conditioning processes (e.g., generalization) and general dysfunction, better than traditional, polythetic, diagnostic entities, that, by and large, do not reflect any single coherent psychological process.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxiety Clinic Patients | – | Behavioral: Test of fear conditioningAdult males and females being treated at the anxiety disorders clinic at the University of Minnesota predominantly for clinical anxiety. |
| Healthy Comparisons | – | Behavioral: Test of fear conditioningSex, age, and socioeconomically matched healthy controls |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male and female adults presenting with anxiety symptoms at the Anxiety Disorders Clinic in the Department of Psychiatry at U of MN, as well as demographically matched healthy comparisons
Key inclusion criteria (2 listed)
- Diagnosis: No psychiatric diagnosis is required, but recruitment will be guided by the goal of attaining a sample with wide-ranging levels of both anxiety symptom severity and individual differences in anxiety-related states and traits.
- Caffeine and tobacco use: Participants will abstain from caffeine and tobacco one hour preceding testing
Key exclusion criteria (4 listed)
- Psychiatric health: Current or past history of any psychotic disorder, bipolar disorder, delirium, dementia, amnestic disorder, or mental retardation; comorbid depression if accompanied by current, significant suicide risk; substance use disorder presently or for the six months preceding testing.
- Current use of any medication that alters central nervous system function including antidepressants, benzodiazepines, anti-psychotics, mood stabilizers,anti-parkinsonian agents, anti-convulsants, sleep medications, pain medications, and anti-hypertensives.
- Medical health: Current or past medical illnesses which in the investigator's opinion may confound study results, or place the participant at risk.
- Pregnancy status: Females who are, or may be, pregnant. Recruitment
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 |
|---|---|---|
| Test of fear conditioningBehavioral and brain correlates of conditioned fear generalization and avoidance will be assessed using fMRI and related to levels of anxiety related psychopathology. | Behavioural | Anxiety Clinic Patients, Healthy Comparisons |
Primary outcome
Functional magnetic resonance imaging
Time frame: Years 1-4
Blood oxygenation level dependent responses elicited during the fear conditioning paradigm
1 secondary outcome
Behavioral measures
Time frame: Years 1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Shmuel Lissek, PhD principal investigator
U of MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders, run by University of Minnesota 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 2 inclusion and 4 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 10 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional magnetic resonance imaging (time frame: Years 1-4). 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 10 Mar 2022.