Clinical trial NCT01977729: Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline
Official title: Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anxiety Disorder of Adolescence
Keywords: anxiety
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 1
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical Global Impression Severity & Improvement Scales
timeFrame: 20 weeks from enrollment
Secondary outcomes:
measure: Multidimensional Anxiety Scale for Children
timeFrame: 20 weeks from enrollment
Other outcomes:
measure: Positive and Negative Affect Scale for Children
timeFrame: 20 weeks from enrollment
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University Child Study Center
name: Wendry K. Silverman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: