Fear Conditioning, Extinction and Its Recall in Anxious Youth
FCPA
3 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedDecember 16, 2015
December 1, 2015
2 years
December 2, 2015
December 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fMRI Bold signal
analysis of brain activation
2 years
Secondary Outcomes (6)
Autonomous measures- skin conductance response (SCR)
2 years
Self report of anxiety
2 years
Autonomous measures-Fear-Potentiated Startle
2 years
Anxiety symptom- SCARED
2 years
Anxiety symptoms- ADIS
2 years
- +1 more secondary outcomes
Study Arms (2)
Anxious group
EXPERIMENTALYouth diagnosed with anxiety disorder will receive Cognitive Behavioral Therapy for reducing anxiety symptoms.
Control group
NO INTERVENTIONHealthy youth will be recruited for comparison but their participant in the study will not include intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- diagnosis of Separation Anxiety Disorder, Social Phobia or Generalized Anxiety Disorder.
You may not qualify if:
- other psychiatry diagnose (not include depression and ADHD)
- currently in psychological treatment
- psychiatry medication
- Control group:
- healthy volunteers
- any psychiatry diagnose.
- currently in psychological treatment
- psychiatry medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Haifalead
- HaEmek Medical Center, Israelcollaborator
- Weizmann Institute of Sciencecollaborator
Study Sites (2)
University of Haifa
Haifa, Israel
Weizmann Institue of Science
Rehovot, Israel
Related Publications (5)
Beesdo K, Knappe S, Pine DS. Anxiety and anxiety disorders in children and adolescents: developmental issues and implications for DSM-V. Psychiatr Clin North Am. 2009 Sep;32(3):483-524. doi: 10.1016/j.psc.2009.06.002.
PMID: 19716988BACKGROUNDShechner T, Hong M, Britton JC, Pine DS, Fox NA. Fear conditioning and extinction across development: evidence from human studies and animal models. Biol Psychol. 2014 Jul;100:1-12. doi: 10.1016/j.biopsycho.2014.04.001. Epub 2014 Apr 16.
PMID: 24746848BACKGROUNDShechner T, Britton JC, Ronkin EG, Jarcho JM, Mash JA, Michalska KJ, Leibenluft E, Pine DS. Fear conditioning and extinction in anxious and nonanxious youth and adults: examining a novel developmentally appropriate fear-conditioning task. Depress Anxiety. 2015 Apr;32(4):277-88. doi: 10.1002/da.22318. Epub 2014 Nov 27.
PMID: 25427438BACKGROUNDWalkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.
PMID: 18974308BACKGROUNDBritton JC, Grillon C, Lissek S, Norcross MA, Szuhany KL, Chen G, Ernst M, Nelson EE, Leibenluft E, Shechner T, Pine DS. Response to learned threat: An FMRI study in adolescent and adult anxiety. Am J Psychiatry. 2013 Oct;170(10):1195-204. doi: 10.1176/appi.ajp.2013.12050651.
PMID: 23929092RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 2, 2015
First Posted
December 16, 2015
Study Start
February 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2020
Last Updated
December 16, 2015
Record last verified: 2015-12