Brief Behavioral Activation Treatment for Postpartum Depression
(SUMMIT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment for postpartum depression, a common issue for many new mothers. It aims to determine if a short, structured therapy called Brief Behavioral Activation Treatment is equally effective when delivered by trained nurses or online, compared to specialists in person. English or Spanish-speaking women who are pregnant or have recently given birth and are experiencing significant depression are eligible to participate. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance postpartum depression treatment options.
Will I have to stop taking my current medications?
The trial requires that your psychotropic medication dose or type hasn't changed within two weeks before starting the treatment. If your medication is stable, you may not need to stop taking it.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that behavioral activation (BA) is generally safe for treating postpartum depression. Studies have found that BA, whether conducted in-person or online, effectively reduces depression symptoms in new mothers. Importantly, these studies did not identify any major safety issues.
Another study found that BA is practical and acceptable when provided by community health workers, indicating it is well-received even when delivered by individuals who are not mental health specialists. With training, people without a mental health background can safely offer the treatment.
In summary, evidence suggests that BA is a safe and effective option for those dealing with postpartum depression. Participants in previous studies have generally tolerated the treatment well, with no significant negative effects reported.12345Why are researchers excited about this trial?
Researchers are excited about Brief Behavioral Activation Treatment for postpartum depression because it offers a flexible and accessible approach to mental health care. Unlike traditional therapies that often require in-person sessions with specialists, this treatment can be delivered remotely through telemedicine, allowing new mothers to receive support from the comfort of their homes. It also involves non-specialist providers like nurses or midwives, broadening the pool of potential caregivers and making the treatment more widely available. This adaptability not only increases access but also reduces stigma, as it can be integrated into routine healthcare visits.
What evidence suggests that this trial's treatments could be effective for postpartum depression?
Research has shown that Brief Behavioral Activation (BA) Treatment is highly effective for postpartum depression. Studies have found that BA significantly reduces depression symptoms and suicidal thoughts in women during and after pregnancy. It is as effective as more complex therapies like Cognitive Behavioral Therapy (CBT) for general depression. BA improves mood by encouraging activities that uplift, which is particularly important for new mothers. In this trial, specialists deliver BA in person, through telemedicine, and trained non-specialists also provide it. Each method consistently enhances mental health.14678
Who Is on the Research Team?
Daisy R Singla, PhD
Principal Investigator
Sinai Health System
Are You a Good Fit for This Trial?
The SUMMIT trial is for pregnant women up to 36 weeks or those who are 4-30 weeks postpartum, experiencing depression with an EPDS score of at least 10. Participants must be over 18 and speak English or Spanish. It excludes those with severe fetal issues, recent infant death, active suicidal thoughts, psychosis, recent psychotropic medication changes, ongoing psychotherapy, substance abuse issues, or non-English/Spanish speakers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a brief, manualized behavioral activation treatment delivered either in-person or via telemedicine by specialists or trained non-specialists
Follow-up
Participants are monitored for depressive and anxiety symptoms using standardized scales
Child Mental Health Development
Child mental development is assessed using the Bayley Mental Developmental Scale IV and Home Observation Measurement Evaluation
What Are the Treatments Tested in This Trial?
Interventions
- Brief Behavioral Activation Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mount Sinai Hospital, Canada
Lead Sponsor
Endeavor Health
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
Harvard Medical School (HMS and HSDM)
Collaborator
Women's College Hospital
Collaborator
Unity Health Toronto
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
NorthShore University HealthSystem
Collaborator
University of Colorado, Boulder
Collaborator