Threat-Avoidance Learning in Anxiety Patients

Panic Disorder Clinical Trial

— AVOID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02336802
• Other study ID #: bramvervliet
• Status: Not yet recruiting
• Phase: N/A
• First received: January 8, 2015
• Last updated: February 5, 2015
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2015
• Source: Katholieke Universiteit Leuven
• Contact: Bram Vervliet, Ph.D.
• Phone: +32 16 32 61 17
• Email: bram.vervliet[@]ppw.kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disease
• Panic Disorder
• Phobic Disorders
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Avoidance experiment
Participants complete an avoidance task

Locations

Country	Name	City	State
Belgium	University of KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	European Commission

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional magnetic resonance imaging	We 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.	1.5 hours	No
Secondary	Skin conductance reactivity	fluctuations in skin conductance will be measured alongside MRI data collection, as a peripheral physiological measure of fear.	1.5 hours	No
Secondary	Questionnaires	In a separate sessions, participants will fill out a variety of personality questionnaires probing levels of anxiety and avoidance tendency.	2 hours	No