Anxiety disorders begin during childhood and adolescence and are extremely common, but they are often underdiagnosed and undertreated. If left untreated, these conditions can be chronic and impairing into adulthood. Evidence-based treatments can be highly effective in reducing anxiety disorder symptoms and, for some children, can reduce symptoms to the point of return to normal everyday functioning. Remission, the term that describes when treatment has helped a child/adolescent to have no/very minimal symptoms, occurs in about 65 percent of children and adolescents who are treated with a combination of antidepressant medication and cognitive behavioral therapy (CBT). In contrast, therapy with CBT alone achieves remission in 35 percent of children at three months and 45 percent at six months. Most families prefer to begin treatment for child and adolescent anxiety with CBT, and a common question is what they can expect from adding a medication.
Despite the data above, this question is difficult to answer because in prior research studies, CBT was changed in important ways (e.g., reducing the number of treatment sessions, restricting family involvement, limiting therapists’ flexibility) that may have limited its effects. CBT and COMB, which is CBT and medication, have never been compared on typical patients in real-world settings. There is little information on which features of early treatment progress signal later remission, even though that information could guide a decision about whether to add a medication.
The Partners in Care for Anxious Youth (PCAY) study aims to provide children and families with better information about the relative merits of CBT and COMB in real-world settings. Focusing on primary care settings where most youth already have established relationships with a doctor, we propose to screen youth for anxiety disorder and confirm diagnosis among those who screen positive. Children identified as having an anxiety disorder will be invited to participate in PCAY and, if interested and eligible, will be assigned to either six months of treatment with CBT or six months of treatment with COMB. CBT will be provided by community clinicians; for youth in the COMB group, medication will be provided by their pediatricians. Brief monthly assessments will allow us to collect detailed information on early signs of remission. A follow-up period of six months following the conclusion of treatment will allow us to determine how well gains are maintained. Results from PCAY will help families make more-informed decisions when choosing between CBT and COMB.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.