- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01977729
Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline
April 13, 2016 updated by: Yale University
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
1
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale Child Study Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
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 Names:
|
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.
|
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 Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 weeks from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 weeks from enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 weeks from enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wendry K. Silverman, Ph.D, Yale University Child Study Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
October 30, 2013
First Submitted That Met QC Criteria
November 6, 2013
First Posted (Estimate)
November 7, 2013
Study Record Updates
Last Update Posted (Estimate)
May 16, 2016
Last Update Submitted That Met QC Criteria
April 13, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1308012517
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety Disorder of Adolescence
-
New York State Psychiatric InstituteColumbia UniversitySuspendedAnxiety Disorder of Childhood or AdolescenceUnited States
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedChild Anxiety | Anxiety Disorder of AdolescenceUnited States
-
Steven WeissCompletedAnxiety Disorder of Childhood or Adolescence
-
Baylor College of MedicineRecruitingGeneralized Anxiety Disorder | Panic Disorder | Panic Disorder With Agoraphobia | Separation Anxiety | Anxiety Disorder of Childhood | Panic Attacks | Social Anxiety Disorder of Childhood | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
-
Aga Khan UniversityNot yet recruitingAnxiety Disorders | Mental Disorder in Adolescence | Depression in AdolescencePakistan
-
Mental Health Services in the Capital Region, DenmarkFrederiksberg University Hospital; The Danish Mental Health Foundation; Defactum...CompletedDepressive Symptoms | Mental Health Disorder | Emotional Problem | Anxiety Disorder of Childhood | Behavior Problem of Childhood and AdolescenceDenmark
-
Baylor College of MedicineCompletedGeneralized Anxiety Disorder | Panic Disorder | Separation Anxiety | Panic Attacks | Social Anxiety Disorder of Childhood | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in Adolescence | Panic With AgoraphobiaUnited States
-
KronikguneNorwegian University of Science and Technology; University of Aarhus; University... and other collaboratorsUnknownDepressive Symptoms | Anxiety Symptoms | Violence in Adolescence | Mental Disorder in Adolescence | Cyberbullying | Bullying of Child | School Absenteeism | Behavioral Problem of ChildIceland, Denmark, Italy, Poland, Spain
-
Karakter Kinder- en JeugdpsychiatrieNot yet recruitingObsessive-Compulsive Disorder in Adolescence
-
3-C Institute for Social DevelopmentUniversity of Miami; Stony Brook UniversityCompletedDepression | Anxiety | Depression, Anxiety | Depression in AdolescenceUnited States
Clinical Trials on Cognitive Behavioral Therapy
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
University of PittsburghCompletedDepression | Anxiety | Sickle Cell DiseaseUnited States