Child and Adolescent Anxiety Disorders (CAMS)

Study Overview
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Brief Summary
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This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.

Detailed Description
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Anxiety disorders are among the most common conditions affecting children and adolescents. These disorders impair school, social, and family functioning. When left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. Previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo. During Phase I of this two-phase study, 488 participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.

Official Title
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Child/Adolescent Anxiety Multimodal Treatment Study

Conditions
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Anxiety Disorders, Social Phobia, Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: Sertraline (SRT)
* Behavioral: Cognitive Behavioral Therapy (CBT)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder Exclusion Criteria: Major neurological disorder or medical illness that would interfere with participation in the study

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sertraline<br>Participants received sertraline for 12 weeks. | Drug: Sertraline (SRT)<br>* Participants were treated with sertraline.<br>* Other names: Zoloft;|
| Active Comparator: CBT<br>Participants received cognitive behavioral therapy for 12 weeks | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* Participants received CBT.<br>|
| Active Comparator: SRT + CBT<br>Participants received both sertraline and CBT for 12 weeks. | Drug: Sertraline (SRT)<br>* Participants were treated with sertraline.<br>* Other names: Zoloft;Behavioral: Cognitive Behavioral Therapy (CBT)<br>* Participants received CBT.<br>|
| Placebo Comparator: Placebo<br>Participants received a placebo pill for 12 weeks. | Drug: Placebo<br>* Participants were treated with a placebo pill.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Improvement Scale | The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale. | Measured at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phobic Disorders, Anxiety, Separation