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 and anxiety affect 10 to 20 percent of women during pregnancy or in the year after childbirth. Talk therapy is effective for depression and anxiety, and women prefer it over medicine. But many women can’t access talk therapy because of its cost, problems with transportation, or a lack of mental health professionals.
Behavioral activation, or BA, is a form of talk therapy that requires as few as eight sessions. BA is usually given in person by a mental health professional. But research has shown that people without formal training in mental health therapy, such as peers, nurses, or lay counselors, can provide effective BA.
This study is comparing the effectiveness of BA provided by a mental health professional versus a nurse or midwife. It is also comparing in-person BA with BA given through telemedicine, or by videoconference.
In this study, pregnant and postpartum women are in one of four groups:
- In-person BA with a mental health professional
- In-person BA with a nurse or midwife
- Telemedicine BA with a mental health professional
- Telemedicine BA with a nurse or midwife
Who can this research help?
Clinicians, patients, and health systems could use these findings when considering how to treat depression and anxiety in pregnant and postpartum women.
What is the research team doing?
The research team is enrolling 1,368 women receiving care from clinics in Toronto, Ontario; Chapel Hill, North Carolina; and Chicago, Illinois. Women in the study are either pregnant or gave birth within the past six months. The team is assigning patients by chance to receive BA in person or by telemedicine and from a mental health professional or a trained nurse.
Women in all four groups are receiving six to eight BA sessions. During these sessions, women are focusing on increasing enjoyable and fulfilling activities that align with their values. Women receiving in-person BA are having sessions at the study clinics and health centers. Those receiving telemedicine BA are having sessions by phone, tablet, or computer. Women in the study are completing surveys on depression and anxiety symptoms before starting BA and after 3, 6, and 12 months.
Mothers, patient advocates who have experienced depression or anxiety, mental health professionals, clinicians, insurers, and policy makers are helping the research team plan and carry out the study.
Research methods at a glance
|Design||Randomized controlled trial|
|Population||1,368 pregnant or postpartum women|
Primary: depressive symptoms
Secondary: anxiety symptoms, patient-clinician relationship quality, patient activation levels, perceived support, therapeutic alliance, patient satisfaction, health service utilization, treatment dose, dropout, session-wise depression scores, homework adherence, child birthweight and length, child mental development, and child psychosocial stimulation
|Timeframe||3-month follow-up for primary outcome|