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?
Depression is a health problem that causes people to feel sad, hopeless, or empty. These feelings occur on most days and last more than two weeks. Talk therapy and exercise can help people with depression feel better. For example, behavioral activation, or BA, is one type of talk therapy. In BA, therapists help patients learn to use positive activities to improve their mood. Yoga may also help people with depression to feel better. Yoga combines movement, breathing techniques, and meditation to help people reduce stress. But many people with depression don’t have access to in-person therapy or yoga classes.
In this study, the research team is comparing online yoga classes and telehealth BA for treating depression. Telehealth is a way to provide care to patients remotely using phone, video, or monitoring devices.
Who can this research help?
Results may help doctors and patients when considering treatments for depression.
What is the research team doing?
The research team is enrolling 518 patients with depression who live in Massachusetts, Minnesota, North Carolina, or Rhode Island. The team is assigning patients by chance to one of two groups. Patients in the first group receive live, online hatha yoga classes once a week for three months. Hatha yoga focuses on posture and breathing and is suitable for people of all physical abilities. Classes last one hour. Patients join the class from home, and the yoga teacher provides feedback in real time.
Patients in the second group receive eight 1-hour BA sessions over three months via telehealth. The research team is training therapists in local communities to provide these sessions.
The research team is surveying patients about their depression symptoms at the start of the study and again 6, 12, 18, and 24 weeks later. Surveys also ask about their well-being, anxiety, sleep, and physical function.
Patients with depression, patient advocates, health insurers, and staff from community-based organizations and health systems are helping to plan and conduct the study.
Research methods at a glance
Design Element | Description |
---|---|
Design | Randomized controlled trial |
Population | 518 adults ages 18 and older with mild to moderate depression symptoms |
Interventions/ Comparators |
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Outcomes | Primary: depression symptom severity Secondary: physical functioning, anxiety, depression, fatigue, sleep disturbance, ability to participate in roles and activities, pain interference/intensity |
Timeframe | 6-month follow-up for primary outcome |