A Pilot Study of Fear Extinction Learning in Anxious Youth

Anxiety Disorder of Childhood Clinical Trial

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

Status Completed

Clinical Trial Summary

The goal of this proposed study is to identify a potential biobehavioral marker of CBT outcome in the most common child and adolescent anxiety disorders, including separation anxiety disorder (SAD), social phobia (SoP), and generalized anxiety disorder (GAD), and to replicate in a clinical sample the previous finding from animal and non-clinical human samples that a difference exists in extinction learning across development.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Anxiety Disorder of Childhood
• Anxiety Disorders

• NCT number: NCT03032926
• Study type: Observational
• Source: Weill Medical College of Cornell University
• Status: Completed
• Start date: February 2014
• Completion date: July 2016