FCPA: Fear Conditioning, Extinction and Its Recall in Anxious Youth

Sponsor
University of Haifa (Other)
Overall Status
Unknown status
CT.gov ID
NCT02631785
Collaborator
HaEmek Medical Center, Israel (Other), Weizmann Institute of Science (Other)
60
2
2
48
30
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Study Details

Study Description

Brief Summary

The proposed research aims to isolate brain-based information-processing mechanisms implicated in perturbed fear learning and extinction characteristic of pediatric anxiety.

The study will focus on the therapeutic relevance of dysfunction in fear learning and extinction for treatment by examining the associations between brain functioning and response to exposure intervention in anxious children.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive Behavioral Therapy
N/A

Detailed Description

Anxiety disorders are the most common form of pediatric psychopathology, affecting 5 - 20% of children and adolescents. Despite therapeutic advances, treatment-resistance remains high, and progress towards early detection of at-risk populations and more effective treatments has stalled. Although some anxiety disorders are transient, recent studies suggest that pediatric anxiety disorders commonly persist into adulthood. Because anxiety disorders are costly and debilitating conditions that are very often associated with other severe psychopathology such as substance abuse, depression and suicidality, there is an imperative need to identify risk and resilience factors that moderate pediatric anxiety and improve treatment.

Fear conditioning and resistance to extinction are two domains that have been implicated in the etiology and maintenance of anxiety disorders. Indeed, one of the most effective treatment for pediatric and adult anxiety disorders, exposure therapy, relies profoundly on extinction learning. The proposed research plan will investigate the neural correlates of aberrant fear conditioning and extinction processes in children and adolescents with anxiety disorders.

The proposed research aims to isolate brain-based information-processing mechanisms implicated in perturbed fear learning and extinction characteristic of pediatric anxiety. A fMRI study using a novel age-appropriate fear conditioning-extinction paradigm are proposed. The study will delineate perturbed psychological and psychophysiological response to fear conditioning and isolate neuro-cognitive mechanisms mediating extinction recall in anxious and non-anxious children. Three weeks after completing fear conditioning and extinction task in the psychophysiology lab, participants will return to complete an fMRI extinction-recall task quantifying responses to extinguished CS blends. Two major hypotheses will be examined:

  1. anxious children will exhibit perturbations during extinction as measured by psychophysiology indexes and self-reported fear compared to non-anxious children; b) less activation in ventromedial prefrontal cortex (vmPFC) is expected in anxious, relative to healthy, children during extinction-recall. Furthermore, the study will focus on the therapeutic relevance of dysfunction in fear learning and extinction for treatment by examining the associations between vmPFC function and response to exposure intervention in anxious children. Lower levels of vmPFC activation prior to exposure therapy and larger pre-to-post-treatment changes in vmPFC activity are expected to be associated with better response to exposure therapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Fear Conditioning, Extinction and Its Recall in Anxious Youth: Identifying Neuro- Cognitive Abnormalities and Their Relation to Pediatric Anxiety Treatment Outcomes
Study Start Date :
Feb 1, 2016
Anticipated Primary Completion Date :
Feb 1, 2018
Anticipated Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anxious group

Youth diagnosed with anxiety disorder will receive Cognitive Behavioral Therapy for reducing anxiety symptoms.

Other: Cognitive Behavioral Therapy
Psychologists will deliver the "COPING CAT" treatment for reducing anxiety symptoms. It is a manualized treatment that was extensively used before. The treatment will include 10- 14 sessions, mostly individual but also two parents meetings. All the treatments will occur in the Department of Psychology in Haifa University as a part of a clinical trial. The treatment will take place in a room that was designed for this purpose fully equipped with cameras, microphone and double sided mirror. All sessions will be audio and video recorded and will be closely monitored by the PI. To increase protocol adherence and verify the adequacy of the treatment delivered, all clinicians will complete routine forms with the content of each session.
Other Names:
  • CBT
  • No Intervention: Control group

    Healthy youth will be recruited for comparison but their participant in the study will not include intervention.

    Outcome Measures

    Primary Outcome Measures

    1. fMRI Bold signal [2 years]

      analysis of brain activation

    Secondary Outcome Measures

    1. Autonomous measures- skin conductance response (SCR) [2 years]

      skin conductance response (SCR) will be recorded from the participant's hand using two standard electrodes attached to the participants' palm.

    2. Self report of anxiety [2 years]

      participants will rate their level of fear during watching stimuli

    3. Autonomous measures-Fear-Potentiated Startle [2 years]

      will be measured through electromyography (EMG) of the eye-blink reflex following a puff of air to the forehead.

    4. Anxiety symptom- SCARED [2 years]

      • The Screen for Child Anxiety Related Emotional Disorders (SCARED) - the SCARED is a self-report measure that assesses different types of anxiety based on criteria in the DSM-IV. Specifically, the SCARED was developed as a screening tool for generalized anxiety disorder, separation anxiety disorder, panic disorder, social phobia, and school phobia. The SCARED has been reported to have robust reliability and validly (Birmaher et al., 1997).

    5. Anxiety symptoms- ADIS [2 years]

      The Anxiety Disorder Interview Schedule (ADIS) - is a well validated semi-structured diagnostic interview, suitable for measuring all anxiety disorders as listed in the DSM-IV as well as mood disorders and attention deficit hyperactivity disorder, in children from 7-17 years of age (Silverman & Albano, 1996). The interview has two versions, one for children (ADIS-C) and one for parents (ADIS-P), and both have good inter-rater and high test-retest reliability (Silverman, Saavedra, & Pina, 2001). In standard ADIS procedures, a child receive a diagnosis when a specified amount of criteria are met the child or parent reports substantial interference (4 or higher on a scale from 0 to 8). The combined diagnosis represents a sum of the diagnoses of the child and the parent interview

    6. Anxiety symptoms- CGI [2 years]

      Clinical Global Impression scale (CGI). The CGI scale requires clinicians to rate the overall severity of their patient's illness at the time of assessment relative to the clinician's experience with patients having the same diagnosis. This scale yields three different measures: severity of illness, global improvement, and the efficacy index. The ratings range from 1 (very much improved) to 7 (very much worse) (Busner & Targum, 2007).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Research Group:
    Inclusion Criteria:
    • diagnosis of Separation Anxiety Disorder, Social Phobia or Generalized Anxiety Disorder.
    Exclusion Criteria:
    • other psychiatry diagnose (not include depression and ADHD)

    • currently in psychological treatment

    • psychiatry medication

    Control group:
    Inclusion Criteria:

    healthy volunteers

    Exclusion Criteria:
    • any psychiatry diagnose.

    • currently in psychological treatment

    • psychiatry medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Haifa Haifa Israel
    2 Weizmann Institue of Science Rehovot Israel

    Sponsors and Collaborators

    • University of Haifa
    • HaEmek Medical Center, Israel
    • Weizmann Institute of Science

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tomer Shechner, Principal Investigator, University of Haifa
    ClinicalTrials.gov Identifier:
    NCT02631785
    Other Study ID Numbers:
    • 97-15
    • 1377/14
    • 618534
    First Posted:
    Dec 16, 2015
    Last Update Posted:
    Dec 16, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Tomer Shechner, Principal Investigator, University of Haifa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2015