Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline
Condition: Anxiety Disorder of Adolescence
MeSH terms: Anxiety Disorders
Intervention: Sertraline; Cognitive Behavioral Therapy
Intervention description: 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.; 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.
Intervention MeSH terms: Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 8 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: anxiety

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  meet criteria for a primary Diagnostic and Statistical Manual of Mental Disorders, 5th
             Edition (DSM-5) anxiety disorder of generalized anxiety disorder (GAD), social phobia
             (SOP), and separation anxiety disorder (SAD) using the DSM-5 version of the Anxiety
             Disorders Interview Schedule -Child and Parent Versions (ADIS-C/P)

          -  receive a mean score of 4 or greater on the ADIS-C/P Clinician Rating Scale of
             Severity (CSR)

          -  cease all other psychosocial treatment upon consultation with the clinic staff and the
             service provider

          -  not currently using any psychotropic medication other than a stable dose of stimulant
             medication treatment for comorbid ADHD. Youth who are on a stable dose of stimulant
             medication (i.e., a minimum of six months at the same dose) will be included so as not
             to limit generalizability.

          -  be between 8 and 16 years old

          -  have a negative pregnancy test, if they are menstruating girls. If participating in
             Phase II of the project (i.e., sertraline [SRT] vs. CBT + SRT) and they are sexually
             active, they must be using an appropriate method of birth control. Of additional note
             is that it is an allowable possibility to include children who have coexisting
             psychiatric diagnoses of lesser severity than the three target disorders including
             attention deficit-hyperactivity disorder (ADHD) while receiving stable doses of
             stimulant, obsessive compulsive, post-traumatic stress, oppositional defiant, and
             conduct disorders.

        Exclusion Criteria:

          -  meet for primary diagnosis of any DSM-5 disorder other than GAD, SOP, and SAD

          -  have any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive
             Developmental Disorders, Mental Retardation, Selective Mutism, Organic Mental
             Disorders, Bipolar Disorder, Tourette's Disorder, Schizophrenia and Other Psychotic
             Disorders. Drug or alcohol abuse/dependence will also be exclusionary.

          -  report the presence of any active suicidal ideation or a past suicide attempt in the
             last 6 months. Adolescents with a history of non-lethal self-harm behaviors (e.g.,
             cutting) will be allowed to enroll if they meet other criteria

          -  have an intellectual disability as reported by guardian. If IQ is questionable or has
             not been assessed, the Block Design and Vocabulary subtests of the Wechsler
             Intelligence Scale for Children (WISC-IV) will be administered. If the youth receives
             an IQ subtest score < 6 on either one of these two subtests of the WISC-IV, a full
             scale IQ score (FSIQ) will be obtained. Children with FSIQ < 80 will be excluded

          -  be a victim of past or present undisclosed abuse requiring investigation or ongoing
             supervision by the Connecticut Department of Children and Families.

          -  have an unstable medical condition or a medical condition that could be worsened by
             selective serotonin reuptake inhibitors (SSRIs) such as a bleeding disorder or an
             active seizure disorder

          -  be using concomitant non-psychiatric medications that could be unsafe for use with
             sertraline (anticoagulants, triptans for migraine treatment, dextromethorphan)

          -  have a history of nonresponse to two adequate trials of SSRIs or an adequate trial of
             CBT or have a history of intolerance or nonresponse to sertraline

          -  be girls who are pregnant or are sexually active and are not using an effective method
             of birth control.