Clinical trial NCT01977729
Conditions: Anxiety Disorder of Adolescence
Keywords: anxiety
Sponsor: Yale University
Start date: 2013-10-01; Completion date: 2014-09-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19. The same therapist as in Phase I will deliver CBT in Phase II, which will occur in conjunction with the psychiatrist visits. Phase II CBT will emphasize continued therapist prescribed in-session and out-of-session exposure tasks (developed with patient) and continued patient cognitive-affective processing of exposure sessions with therapist, with no instruction on new skills or therapeutic strategies. Therapists will be encouraged to discuss clinical status with patients, psychiatrists, and PIs to allow for treatment integration (e.g., psychiatrist could increase the dose of SRT, or not, depending on whether the patient Is making sufficient progress in CBT). arm 2: Sertraline is a selective serotonin reuptake inhibitor. Sertraline is FDA approved for the treatment of major depressive disorder, obsessive compulsive disorder, posttraumatic stress disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder in adults. Sertraline is also approved for the treatment of obsessive compulsive disorder in children and adolescents. Pharmacotherapy visits will be scheduled at weeks 9-12, 14, 16, 18, 20 with phone visits at weeks 15, 17, and 19. The psychiatrist will meet for \~30 min. with the youth and parents. Efforts will be made to use the most effective and tolerated SRT dose.
Interventions: intervention 1: Sertraline intervention 2: Cognitive Behavioral Therapy
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents: