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Trial record 34 of 329 for:    SERTRALINE

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

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ClinicalTrials.gov Identifier: NCT01977729
Recruitment Status : Terminated (funding)
First Posted : November 7, 2013
Results First Posted : April 13, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

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).

Condition or disease Intervention/treatment Phase
Anxiety Disorder of Adolescence Drug: Sertraline Behavioral: Cognitive Behavioral Therapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline
Study Start Date : October 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: CBT with SRT
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
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.
Other Name: CBT

Experimental: Switch to SRT alone
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
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.
Other Names:
  • Zoloft
  • Lustral

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.
Other Name: CBT




Primary Outcome Measures :
  1. Clinical Global Impression Severity & Improvement Scales [ Time Frame: 20 weeks from enrollment ]
    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.


Secondary Outcome Measures :
  1. Multidimensional Anxiety Scale for Children [ Time Frame: 20 weeks from enrollment ]
    Multidimensional Anxiety Scale for Children (MASC-2; Self-report and Parent completed). Treatment outcome will be assessed on a specific symptom level from the youth's and parent's perspective using the MASC-2. The MASC-2 consists of 50 items across 5 factors: Separation Anxiety/Phobias, Generalized Anxiety Disorder, Social Anxiety, Obsessions & Compulsions, and Harm Avoidance. MASC T-scores less than 65 indicate the child is no longer in the clinical range of anxiety symptoms.


Other Outcome Measures:
  1. Positive and Negative Affect Scale for Children [ Time Frame: 20 weeks from enrollment ]
    Positive and Negative Affect Scale for Children (PANAS-C). Negative affect (NA) will be assessed using the NA subscale on the PANAS-C. The 15 NA items (e.g., sad, miserable) on the 27-item PANAS-C are scored 1 (very slightly or not at all) to 5 (extremely). Higher scores in the NA subscale indicate higher levels of negative affect.



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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977729


Locations
United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Wendry K. Silverman, Ph.D Yale University Child Study Center

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01977729     History of Changes
Other Study ID Numbers: 1308012517
First Posted: November 7, 2013    Key Record Dates
Results First Posted: April 13, 2016
Last Update Posted: May 16, 2016
Last Verified: April 2016

Keywords provided by Yale University:
anxiety

Additional relevant MeSH terms:
Sertraline
Anxiety Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs