Project Summary
COVID-19-Related Project EnhancementThe COVID-19 pandemic has exacerbated the ways in which our current outpatient model does not meet the needs of families with anxious children (e.g., access barriers, therapist shortages). Moreover, the pandemic is causing an increasing need for treatment to help patients with anxiety related to the pandemic itself. Telehealth treatment models are a necessary health system adaptation in the current health crisis, but also may improve access to care post pandemic. The current study of comprehensive patient-centered versus traditional provider-centered delivery has been enhanced by the addition of a patient-centered telehealth condition. The enhancement aims to evaluate the effectiveness of this novel telehealth delivery system that allows for access to anxiety treatment during the current pandemic, extends the reach of services to relevant contexts outside of the office, and expands the labor pool of available providers. Enhancement Award Amount: $499,327 |
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?
Feeling anxious is a normal way to react to stressful events or situations. But youth with an anxiety disorder have fear, worry, or nervousness that may keep them from doing their regular daily activities. Obsessive-compulsive disorder, or OCD, is a type of anxiety disorder. People with OCD have uncontrollable and repeated thoughts and behaviors. Cognitive behavioral therapy, or CBT, is the preferred treatment for anxiety and OCD. With CBT, patients learn to change their patterns of thinking and behaving. Usually, people go to an office or clinic to get CBT from mental health specialists like psychologists.
In this study, the research team is comparing two ways to provide CBT treatment for youth with anxiety or OCD. The first is CBT at a psychologist’s office. The second is CBT at a psychologist’s office and at the patient’s home. The team is looking at how well these treatments work to improve patients’ symptoms and quality of life.
Who can this research help?
Mental health clinicians can use results from this study when planning how to care for youth with anxiety or OCD.
What is the research team doing?
The research team is recruiting 333 youth ages 5 to 18 in Rhode Island. Patients must have had symptoms of anxiety or OCD for at least three months before starting the study. Patients must also have a parent or caregiver who can participate in treatment.
The research team is assigning patients by chance to one of two treatment groups:
- Office-based CBT. Patients see a psychologist in an office for 60-minute CBT treatments four times a month for six months.
- Home-based CBT. Patients see a psychologist in an office for 60-minute CBT treatments once a month for six months. Patients also get a 90-minute home visit with a trained mobile exposure coach three times a month for six months. Coaches have a bachelor’s degree and receive training from psychologists on treating youth with anxiety and OCD. These coaches help patients get the mental health care they need. The treating psychologist supervises the coaches through weekly meetings.
The research team is using interviews and surveys to ask patients and parents about anxiety and OCD symptoms. They also ask about quality of life and satisfaction with mental health services. Patients and parents answer questions at the start of the study and every six weeks for six months. They also answer questions three and six months later.
Patients, families, health insurers, and health system administrators are working with the research team to plan and conduct the study.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 333 youth ages 5 to 18 diagnosed with anxiety or OCD who have had symptoms for at least 3 months before starting the study |
| Interventions/ Comparators |
|
| Outcomes |
Primary: anxiety symptoms and severity, OCD symptoms and severity Secondary: family engagement with treatment, family satisfaction with mental health services, quality of life, functional impairment, caregiver burden, family accommodation, barriers to treatment access, time course of response to treatment, durability of treatment gains, provider volume and capacity, efficiency in treatment |
 |
Up to 6-month follow-up for primary outcomes |
Project Details
Other Clinical Interventions
Care Coordination
Other Health Services Interventions
Training and Education Interventions
Improving Healthcare Systems