Threat-Avoidance Learning in Anxiety Patients

NCT02336802 | Unknown

• 1 other identifier: bramvervliet
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder; Phobic Disorders; Stress Disorders, Traumatic

Keywords

Anxiety; Fear; Avoidance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Skin conductance reactivity

  1.5 hours

• Questionnaires

  2 hours

Study Arms (4)

Healthy Control Group

Volunteers that meet no diagnostic criteria for mental disorders.

Behavioral: Avoidance experiment

Panic Disorder Group

Volunteers that meet diagnostic criteria for Panic Disorder.

Behavioral: Avoidance experiment

Phobic Disorder Group

Volunteers that meet diagnostic criteria for a Phobic Disorder.

Behavioral: Avoidance experiment

PTSD group

Volunteers that meet diagnostic criteria for Post-Traumatic Stress Disorder

Behavioral: Avoidance experiment

Interventions

Avoidance experiment BEHAVIORAL

Participants complete an avoidance task

Healthy Control Group; PTSD group; Panic Disorder Group; Phobic Disorder Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Controls, Panic Disorder, Phobic Disorders, Post-Traumatic Stress Disorder

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• European Commission: collaborator

Study Sites (1)

University of KU Leuven

Leuven, 3000, Belgium

Location

Related 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.

  PMID: 19748076 BACKGROUND

• 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.

  PMID: 22129456 BACKGROUND

MeSH Terms

Conditions

Panic Disorder; Phobic Disorders; Stress Disorders, Traumatic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Trauma and Stressor Related Disorders

Study Officials

• Dirk Hermans, Prof.

  University of KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bram Vervliet, Ph.D.

CONTACT

+32 16 32 61 17; bram.vervliet@ppw.kuleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2018
• Last Updated: February 6, 2015

Record last verified: 2015-01

Locations

BE (1)