Summary: Childhood anxiety disorders affect a significant percentage of youth and cause substantial distress and impairment. Cognitive-behavioral therapy (CBT) and selective serotonin reuptake inhibitor (SSRI) monotherapies are effective and comparable treatments of childhood-onset anxiety disorders. While CBT lacks the side effects of SSRI therapy, there are practical concerns of dissemination due to the limited availability of trained clinicians; limited treatment center/therapist locations; travel expenses; and immediate treatment costs. Accordingly, there has been a growing body of research on the practicality and efficacy of computerized cognitive-behavioral therapy (CCBT).
This project is evaluating the feasibility and preliminary efficacy of disseminating a CCBT protocol to community mental health centers. An efficacious CCBT protocol could contribute to public health efforts to address the mental health needs of a large number of children diagnosed with anxiety disorders.
The project consists of a two-phase trial that evaluates the feasibility of implementing a patient-centered intervention in community mental health centers, followed by an efficacy trial. In Phase I, an open trial of CCBT that focuses on feasibility issues of providing this intervention in community mental health centers will be completed. The CCBT protocol will be tested in 18 youth, age 7-13 years, to determine its acceptability and feasibility. Assessment and treatment delivery protocols will be refined; feedback will be obtained from patients, families, therapists, and organizational consultants; and barriers will be identified and addressed in preparation for the Phase II trial.
In Phase II, a randomized controlled trial will: 1) compare CCBT to treatment-as-usual (TAU) in order to evaluate the acute efficacy of CCBT relative to TAU in youth with clinically significant anxiety disorders; 2) determine whether CCBT results in greater short-term treatment efficacy relative to TAU after treatments are withdrawn; 3) examine whether CCBT results in improved global functioning and reduced child and parent anxiety symptoms relative to TAU; and 4) examine whether CCBT is associated with greater satisfaction and consumer acceptability than TAU.
While this study is being coordinated by a research team at the University of South Florida Rothman Center for Neuropsychiatry, recruitment will take place at three community mental health centers that serve families of lower socioeconomic status throughout Florida.
- Assess CCBT for clarity, completeness, and feasibility in a pilot study of 18 children ages 7-13 years, with significant involvement from caregivers. (Ongoing)
- Conduct a randomized controlled trial of 110 children to determine the efficacy of CCBT relative to TAU. (Upcoming)
- Examine factors that may predict CCBT outcome. (Upcoming)
2011 Activities: In its first quarter of its first year, the project focused upon start-up activities. During regularly scheduled phone meetings, Dr. Storch, University of South Florida research staff and investigators, and site coordinators and therapists discussed varying aspects of the research plan. The University of South Florida obtained site subcontracts for each performance site. These subcontracts outlined the scope of work required of each site to receive payment.
Changes to the protocol, informed consent, and related study forms were finalized, submitted to, and approved by the institutional review board (IRB). IRB study approval was obtained from the performance sites. The site therapists, coordinators, and study investigators completed IRB ethics and other required training.
A 2-day training for all study coordinators, therapists, research investigators, and consultants was organized at the University of South Florida. The training explained the procedures for implementing the protocol, both from a logistical (organization, participant tracking, safety monitoring, etc.) and application perspective (treatment and assessment protocols). Therapists were trained to implement the treatment protocol.
As last self-reported in the AHRQ Research Reporting System, project progress and activities are completely on track and project budget spending is roughly on target.
Preliminary Impact and Findings: The project has no findings to date.
Target Population: Chronic Care*, Mental Health/Depression, Pediatric*
Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to improve health care decisionmaking through the use of integrated data and knowledge management.
Business Goal: Implementation and Use