Project Summary
PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project and others.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
About 4.4 million youth ages 3 to 17 have an anxiety disorder. Youth with anxiety disorders may have unfounded fears, trouble separating from their parents, a hard time sleeping, or obsessive thoughts. They may also have physical symptoms like sweating, shortness of breath, or stomachaches. Cognitive behavioral therapy, or CBT, is one kind of treatment for anxiety disorders. In CBT, youth learn about their anxiety and strategies for overcoming it.
Most youth with anxiety disorders don’t get treatment. They may have a hard time getting to appointments or may avoid mental health treatment because they have negative beliefs about it. A lack of therapists may make it difficult for them to find treatment. Youth who are from minority backgrounds or from families with low incomes may have an especially hard time getting treatment.
In this study, the research team wants to know if offering CBT through an online program is similar to having in-person sessions with a therapist in improving anxiety symptoms. The research team also wants to know if the severity of anxiety, how far they live from a clinic, or other factors affect how youth do with online or in-person CBT.
Who can this research help?
This research can help youth and their doctors when considering treatment options for anxiety disorders. Health clinics can use the study’s results when considering services for youth with anxiety disorders.
What is the research team doing?
The research team is recruiting 1,856 youth ages 3 to 18 with anxiety disorders receiving care from clinics across the United States. The team is assigning youth to one of two groups by chance. The first group is receiving eight sessions of online CBT with phone support from a therapist every two weeks. The second group is receiving eight in-person CBT sessions with a therapist. Both groups complete the CBT in four months or less. Therapy in both groups is available in English or Spanish.
Youth or their parents are filling out surveys when they first start CBT and six weeks, three months, one year, and two years after treatment. The surveys ask questions about symptoms of fear, anxiety, and stress; behaviors to avoid fear; and how much anxiety interferes with their life.
Youth with anxiety disorders and their parents, mental health professionals, and other partners are working with the research team to help plan the study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | Children ages 3–18 with elevated anxiety at the time of screening |
| Interventions/ Comparators |
|
| Outcomes |
Primary: fear, anxiety, misery, hyper-arousal, somatic symptoms related to arousal, behavioral fear avoidance, life interference and impairment associated with anxiety Secondary: parents’ beliefs and attitudes about technology; therapist attitudes toward adoption of evidence-based practices; report of psychosocial problems by doctor; report of organizational readiness for change by staff; youth reports of depression, anxiety, stress, value of services received; barriers to treatment participation; technological ease and computer-based habits; youth program attendance and homework compliance; beliefs about child anxiety |
| Up to 2-year follow-up for primary outcomes |