NCT01977729

Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) in combination with sertraline (SRT) is more effective than SRT alone in treating children and adolescents with anxiety disorders (after an initial 8 weeks of CBT).

Detailed description

This project proposes to conduct a pilot study to collect preliminary data on a 'personalized adaptive treatment' approach for children and adolescents with anxiety disorders. All youth patients in this two site study will first receive CBT and all then will be re-assessed at mid-treatment (8 sessions). Patients who show a partial response or no response following 8 sessions of CBT will be randomized to either a switch to SRT alone or CBT augmentation with SRT.

Conditions

• Anxiety Disorder of Adolescence

Interventions

Type	Name	Description
DRUG	Sertraline	Medication will be administered daily using a "fixed-flexible strategy" beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater. The dose will be held or adjusted downward if patients have few anxiety symptoms (CGI-S\<3) or impairing Adverse Events. Patients will be maintained at 200mg per day during wks 18-20.
BEHAVIORAL	Cognitive Behavioral Therapy	Youth are given instructions in each session that they may stop whenever they want and they do not need to attempt the task unless they so desire. Therapists have been carefully and thoroughly trained in providing reassurance and/or crisis treatments if needed. Therapists also have been trained to contact one of the PIs immediately in the event of a crisis.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-11-07
• Last updated: 2016-05-16
• Results posted: 2016-04-13

Locations

1 site across 1 country: United States