Conditions: Anxiety Disorders Social Phobia Generalized Anxiety Disorder
Keywords: Phobic Disorders Anxiety, Separation
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 488
Healthy volunteers: yes

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.

Arms:
arm 1: Participants received sertraline for 12 weeks. arm 2: Participants received cognitive behavioral therapy for 12 weeks arm 3: Participants received both sertraline and CBT for 12 weeks. arm 4: Participants received a placebo pill for 12 weeks.

Interventions: intervention 1: Sertraline (SRT) intervention 2: Cognitive Behavioral Therapy (CBT) intervention 3: Placebo
Intervention descriptions: intervention 1: Participants were treated with sertraline. intervention 2: Participants received CBT. intervention 3: Participants were treated with a placebo pill.

Protocol document: