Child/Adolescent Anxiety Multimodal Treatment Study
Overview
- Phase
- Phase 3
- Intervention
- Sertraline (SRT)
- Conditions
- Anxiety Disorders
- Sponsor
- Johns Hopkins University
- Enrollment
- 488
- Locations
- 6
- Primary Endpoint
- Clinical Global Impression - Improvement Scale
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Sertraline
Participants received sertraline for 12 weeks.
Intervention: Sertraline (SRT)
CBT
Participants received cognitive behavioral therapy for 12 weeks
Intervention: Cognitive Behavioral Therapy (CBT)
SRT + CBT
Participants received both sertraline and CBT for 12 weeks.
Intervention: Sertraline (SRT)
SRT + CBT
Participants received both sertraline and CBT for 12 weeks.
Intervention: Cognitive Behavioral Therapy (CBT)
Placebo
Participants received a placebo pill for 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Clinical Global Impression - Improvement Scale
Time Frame: Measured at Week 12
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.