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Threat-Avoidance Learning in Anxiety Patients

The Experimental Study of Threat-Avoidance in Anxiety Patients: Behavioral, Emotional, and Neural Correlates

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02336802
Acronym
AVOID
Enrollment
80
Registered
2015-01-13
Start date
2016-01-31
Completion date
2018-12-31
Last updated
2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panic Disorder, Phobic Disorders, Stress Disorders, Traumatic

Keywords

Anxiety, Fear, Avoidance

Brief summary

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.

Interventions

BEHAVIORALAvoidance experiment

Participants complete an avoidance task

Sponsors

KU Leuven
Lead SponsorOTHER
European Commission
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
functional magnetic resonance imaging1.5 hoursWe will measure functional MRI during fear conditioning, avoidance and generalization. Furthermore, we will measure changes in structural MRI data, Diffusion Tensor Imaging (DTI) data and resting state fMRI data.

Secondary

MeasureTime frameDescription
Skin conductance reactivity1.5 hoursfluctuations in skin conductance will be measured alongside MRI data collection, as a peripheral physiological measure of fear.
Questionnaires2 hoursIn a separate sessions, participants will fill out a variety of personality questionnaires probing levels of anxiety and avoidance tendency.

Countries

Belgium

Contacts

Primary ContactBram Vervliet, Ph.D.
bram.vervliet@ppw.kuleuven.be+32 16 32 61 17

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026