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

NCT01977729 | Terminated Phase 2 Results

• 1 other identifier: 1308012517
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety Disorder of Adolescence

Keywords

anxiety

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression Severity & Improvement Scales

  Youth outcome will be assessed on a global level using the Clinical Global Impression (CGI) Severity Scale, ranging from 1 (not at all) to 7 (among the most extremely ill patients). Higher ratings indicate greater anxiety symptom severity. The CGI Improvement Scale ranges from 1 (very much improved) to 7 (very much worse). Lower ratings indicate greater improvement on anxiety symptom severity. A CGI Improvement Scale rating of 1 or 2 indicates clinically meaningful improvements in anxiety symptom severity.

  20 weeks from enrollment

Secondary Outcomes (1)

• Multidimensional Anxiety Scale for Children

  20 weeks from enrollment

Other Outcomes (1)

• Positive and Negative Affect Scale for Children

  20 weeks from enrollment

Study Arms (2)

CBT with SRT

EXPERIMENTAL

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).

Behavioral: Cognitive Behavioral Therapy

Switch to SRT alone

EXPERIMENTAL

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.

Drug: Sertraline; Behavioral: Cognitive Behavioral Therapy

Interventions

Sertraline DRUG

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.

Also known as: Zoloft, Lustral

Switch to SRT alone

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT

CBT with SRT; Switch to SRT alone

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• meet for primary diagnosis of any DSM-5 disorder other than GAD, SOP, and SAD
• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Sertraline; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Wendy Silverman
• Organization: Yale University

wendy.silverman@yale.edu

(203) 737-7053

Study Officials

• Wendry K. Silverman, Ph.D

  Yale University Child Study Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 7, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 16, 2016
• Results First Posted: April 13, 2016

Record last verified: 2016-04

Locations

US (1)