A Pilot Study of Fear Extinction Learning in Anxious Youth
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|ClinicalTrials.gov Identifier: NCT03032926|
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment|
|Anxiety Disorder of Childhood||Behavioral: Open Trial|
Study Sample and Design: The study will utilize an open treatment pilot trial design. Participants will include 10 individuals, ages 11-18, with a primary anxiety disorder diagnosis. Participants must not have failed prior trials of CBT. Participants on psychiatric medication must be on a stable dose for at least 2 months prior to study participation and remain symptomatic to the level identified for study inclusion (ADIS CSR ≥ 4).
Measures: Independent evaluators will administer a comprehensive assessment at baseline and post-treatment. The Anxiety Disorder Interview Schedule for Children for DSM-5 (ADIS-C-5)19 will measure the primary outcome of change in clinical severity of anxiety disorder symptoms across age groups. The Clinical Global Impression Scale (CGI) will assess overall symptom severity. The PARS and the MASC will provide secondary, dimensional measures of anxiety. In addition, we will measure treatment adherence and parent engagement as important secondary variables.
Fear Conditioning & Extinction Paradigm: Subjects will participate in a laboratory test of extinction training prior to CBT in order to establish extinction learning as a potential predictive marker of treatment outcome. Subjects will be exposed to two shapes on a computer screen, one shape (conditioned stimulus (CS+) will be paired with an aversive sound (unconditioned stimulus) on 38% of the trials, whereas the other shape will never be paired with aversive sound (CS-)20. A day later, individuals will undergo extinction training in which the two conditioned stimuli will be repeatedly presented without the unconditioned stimulus. Extinction will be measured as the difference score of skin conductance response to the CS+ and CS-.
Exposure Therapy Intervention: investigators will offer participants an 8 session exposure therapy intervention. Session one will consist of psychoeducation and completion of an exposure hierarchy. Sessions 2-7 will consist of weekly gradual exposure sessions. Session 8 will include review, relapse prevention and referral to additional treatment if needed. Assessment measures will be given at the completion of each exposure session to assess individual differences in symptom change related to exposure therapy. All treatment sessions will be videotaped to ensure fidelity to treatment manual and modules.
Data analysis plan: Investigators will track the monthly number of participants screened and enrolled to determine feasibility of a larger trial, as well as session attendance, study attrition, treatment adherence and patient safety to assess acceptability of the selected measures and interventions. Though this pilot will not be adequately powered to detect statistical significance, the investigators will execute a preliminary test of the association between performance on the extinction learning task and treatment outcome, and the investigators will assess age group differences in extinction learning and treatment outcome to determine early proof of concept.
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||Enhancing Specificity and Predictability of CBT Outcome for Pediatric Anxiety Disorders: A Pilot Test of a Potential Biomarker for Treatment Response Across Development|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||July 2016|
N/A - Open Trial
Behavioral: Open Trial
- ADIS Evaluation [ Time Frame: 1 year ]Anxiety Disorders Interview Schedule for DSM-5-Adult Version
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032926
|Principal Investigator:||Shannon Bennett, PhD||Weill Cornell Medicine|