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.
COVID-19-Related Project EnhancementThe COVID-19 pandemic is causing significant mental health concerns and treatment needs in the US population. Vulnerable populations, including rural residents, are expected to experience a considerable increase in mental health needs during and after the pandemic among those with and without prior history. The team will explore whether access to remote cognitive behavioral therapy (CBT) will improve mental health symptoms in vulnerable populations. Outcomes of this project could also lead to future comparative clinical effectiveness research, such as a comparison of modes of providing access to remote CBT and comparisons of different online platforms for remote CBT for various population groups. Enhancement Award Amount: $450,314 |
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?
Depression is a health problem that makes people feel sad, hopeless, or empty. These feelings show up most days and last more than two weeks. Cognitive behavioral therapy, or CBT, is one type of treatment for depression. In CBT, patients learn to change their thinking patterns to improve how they feel.
But patients who live in rural areas may have trouble finding CBT for depression close to where they live. Remote CBT may help patients in rural areas get access to therapy for depression. In remote CBT, patients have online therapy sessions.
In this study, the research team is comparing two types of remote CBT with usual primary care for treating depression. The study takes place in rural West Virginia, where usual primary care for depression often involves antidepressant medicine alone.
Who can this research help?
Results may help clinic leaders, doctors, and patients in rural areas when considering ways to treat depression.
What is the research team doing?
The research team is recruiting 3,360 patients with depression from primary care clinics in West Virginia. The team is assigning patients by chance to one of three groups.
Patients in the first group receive usual care plus guided remote CBT. In guided remote CBT, a trained coach helps patients complete online therapy sessions with oversight from a clinical psychologist. The coaches also work with patients by email, text, and phone to help them
- Take antidepressant medicine as directed
- Monitor side effects of medicine
- Determine if medicine is working as intended
- Coordinate with the patient’s doctor
- Get referrals to specialists
Patients in the second group receive usual care plus unguided remote CBT. These patients have access to the same online therapy sessions as patients in the first group. But patients in this group complete therapy sessions online by themselves, without help from a coach. The online program provides automated reminders and encouragement during and between sessions.
Patients in the third group receive usual care for depression from their primary care doctor. Usual care may consist of antidepressant medicine and/or therapy.
The research team is surveying patients 10 times during a one-year period. The team is asking patients if their depression has gotten better and if they are using drugs or alcohol. The team is also looking at medical records to see if patients are receiving antidepressant medicines. About a year after treatment, the team is asking patients if they made shared decisions about depression treatment with their doctor.
The research team is comparing these outcomes between patients in the three treatment groups. In addition, the team is looking to see if certain types of patients benefit from having guided versus unguided treatment, or usual care alone. Finally, the team is looking at whether different types of antidepressant medicine work better than others, alone or in combination with CBT.
Patients with depression, primary care providers, mental health specialists, health insurers, and advocacy groups are helping with this study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 3,360 adults seeking outpatient treatment for major depressive disorder for the first time in the past 6 months |
| Interventions/ Comparators |
|
| Outcomes |
Primary: remission from depression Secondary: severity of substance use, antidepressant medicine adherence, shared decision making about depression treatment |
 |
4-month follow-up for primary outcome |
Project Details
Other Clinical Interventions
Care Coordination
Shared Decision Making
Other Health Services Interventions
Technology Interventions
Training and Education Interventions
Low Income
Rural
Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes