Threat-Avoidance Learning in Anxiety Patients

NCT ID: NCT02336802

Last Updated: 2015-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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Anxiety disorders are characterized by exaggerated levels of fear that are not proportional to the actual level of threat. More specifically, anxiety patients have marked deficits in the downregulation of fear reactions during situations of objective safety. Pre-clinical research on Pavlovian fear conditioning and extinction has discovered that fear downregulation stems from areas in the prefrontal cortex (the ventro-medial prefrontal cortex, vmPFC) that recruit intercalated cells in the amygdala to inhibit its central nucleus, which is responsible for a variety of behavioral expressions of fear (Milad \& Quirk, 2012). Accordingly, functional magnetic resonance imaging studies (fMRI) revealed reduced vmPFC activity coupled with increased fear reactions during situations of objective safety in anxiety patients (Milad et al., 2009). Another core symptom of anxiety disorders, though much less investigated, is the excessive avoidance of situations that trigger the fears. These 'safety behaviors' often interfere with daily life activities and valued goals in life, and they are thought to perpetuate the exaggerated levels of fear by precluding opportunities to learn that the feared situations are actually not dangerous. Surprisingly, experimental research on avoidance behaviors in anxiety patients is virtually non-existent. This experiment modifies the Pavlovian fear conditioning procedure to include avoidance, and explores the behavioral and neural processes of this type of fear regulation in anxiety patients (trans-diagnostically) and healthy individuals.

Detailed Description

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Conditions

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Panic Disorder Phobic Disorders Stress Disorders, Traumatic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Control Group

Volunteers that meet no diagnostic criteria for mental disorders.

Avoidance experiment

Intervention Type BEHAVIORAL

Participants complete an avoidance task

Panic Disorder Group

Volunteers that meet diagnostic criteria for Panic Disorder.

Avoidance experiment

Intervention Type BEHAVIORAL

Participants complete an avoidance task

Phobic Disorder Group

Volunteers that meet diagnostic criteria for a Phobic Disorder.

Avoidance experiment

Intervention Type BEHAVIORAL

Participants complete an avoidance task

PTSD group

Volunteers that meet diagnostic criteria for Post-Traumatic Stress Disorder

Avoidance experiment

Intervention Type BEHAVIORAL

Participants complete an avoidance task

Interventions

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Avoidance experiment

Participants complete an avoidance task

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18-65 years of age. Proficient in English. Right-handed Free of medication that affect cerebral metabolism. Able to give informed consent. High stress level (defined as a score of \>= 3 on the 4-item Perceived Stress Scale).

Exclusion Criteria

History of neurologic or psychiatric disease (other than the specified anxiety disorder), substance abuse or dependence that is current or within the last year.

Major/chronic medical conditions. History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae. History of seizures. History of stroke Prior neurosurgical procedure. Metal in the body, metal injury to the eyes. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt. Pregnancy; breastfeeding or nursing Claustrophobia Weight \> 350 lbs.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Commission

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Bram Vervliet

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dirk Hermans, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of KU Leuven

Locations

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University of KU Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Bram Vervliet, Ph.D.

Role: CONTACT

+32 16 32 61 17

Facility Contacts

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Bram Vervliet, Ph.D.

Role: primary

+32 16 32 61 17

References

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Milad MR, Pitman RK, Ellis CB, Gold AL, Shin LM, Lasko NB, Zeidan MA, Handwerger K, Orr SP, Rauch SL. Neurobiological basis of failure to recall extinction memory in posttraumatic stress disorder. Biol Psychiatry. 2009 Dec 15;66(12):1075-82. doi: 10.1016/j.biopsych.2009.06.026. Epub 2009 Sep 12.

Reference Type BACKGROUND
PMID: 19748076 (View on PubMed)

Milad MR, Quirk GJ. Fear extinction as a model for translational neuroscience: ten years of progress. Annu Rev Psychol. 2012;63:129-51. doi: 10.1146/annurev.psych.121208.131631.

Reference Type BACKGROUND
PMID: 22129456 (View on PubMed)

Other Identifiers

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bramvervliet

Identifier Type: -

Identifier Source: org_study_id

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