Digital Therapy for Postpartum Depression
(HARMONY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to determine if the addition of digital sensing data collected from phones and watches during the early stages of perinatal depression (PND) treatment can better predict treatment outcomes than using self-reported symptoms alone.STAND for PND: The UCLA Depression Grand Challenge (DGC) has previously developed a technology-assisted, scalable therapy system called STAND (Screening and Treatment for ANxiety and Depression) for perinatal depression (PND) and has demonstrated in an initial randomized clinical trial that this treatment intervention to be as effective as psychiatrist delivered care for PND. In this study, the investigators will administer STAND for PND for up to 12 weeks as part of study participation. There will be no comparison between our treatment intervention and a treatment as usual condition, as this is not a trial of efficacy. In the STAND for PND treatment model, women with moderate symptoms will be routed to coach-guided, digital cognitive behavioral therapy (CBT) tailored to PND, which has been demonstrated to be an effective treatment approach for PND. Women with severe depression or suicidality will be routed to clinician delivered CBT, with pharmacotherapy as needed, with both CBT and pharmacotherapy demonstrated to be effective treatment approaches for PND. Symptoms will be regularly monitored throughout the intervention period. Digital Sensing in Depression: The DGC also has substantial experience in large-scale longitudinal digital sensing studies, and experience identifying associations between self-report or clinical ratings of depressive symptoms and digital sensing features, including in pregnant and postpartum women. Digital Sensing in a STAND for PND study: In our previous STAND for PND study, the investigators did not include digital sensing. In this next phase of our research program, the investigators will collect digital sensing data from phones and watches during the first four weeks of study participation. The investigators will enroll up to 250 women during their last trimester or who are in the postpartum period to participate in the 12-week study, which includes treatment provided through the STAND for PND program of care and during which the investigators will obtain 4-weeks of digital sensing data.The investigators will be testing whether behaviors measures through digital sensing (i.e., digital features) in combination with self-reported depression symptoms will better predict treatment outcomes than the self-reported depression symptoms alone. The investigators are testing the hypothesis that prospective longitudinal assessments using digital devices will enhance our ability to predict outcomes of STAND-PND.This project is part of a larger program of research that aims to improve clinical decision-making for PND by establishing a clinical care model for PND that fully integrates digital sensing with digital therapy. An additional objective of this program of research is to target low-income mothers from populations that have had limited access to mental healthcare, given that this population is particularly vulnerable to the impact of PND.
Who Is on the Research Team?
Nelson Freimer, MD
Principal Investigator
University of California, Los Angeles
Michelle G Craske, PhD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
This trial is for women in their last trimester of pregnancy or who have recently given birth and are experiencing symptoms of depression. The study especially aims to include low-income mothers who may not have had much access to mental health care.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Digital Sensing Data Collection
Trial Overview
The study is testing if using data from phones and watches, along with regular symptom check-ins, can better predict how well digital or clinician-guided therapy works for perinatal depression over a 12-week period.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants with a recent EPDS score in the moderate range (11-18) and no current suicidality will be given access to a perinatal depression online cognitive-behavioral therapy course (the ParentMood program). Some of the lesson content is presented as illustrated videos. Following each lesson, participants can download a document that summarizes the key information in each lesson, and which includes practical homework exercises that reinforce the content of the lesson. Participants are encouraged to practice their lesson homework for at least one week before starting the next lesson. Lessons will be completed sequentially. Participants have the option of accessing the content through a web-browser. Participants may receive up to 9 coaching sessions with their assigned Coach, in addition to an initial Orientation session, which will occur through secure video conference. The initial Orientation session is required, but the additional coaching sessions thereafter are optional.
Participants with a recent EPDS score in the severe range (19-30) and/or significant suicidality with intent or means will be given access to a clinical care, which entails weekly psychotherapy sessions. The number and schedule of psychotherapy sessions in the study is determined by the clinical care team. Treatment appointments will occur through secure video conference. If the clinical team believes that consultation with a psychiatrist is warranted, a referral will be made to a UCLA Health clinic (e.g., the MOMS Clinic) for a consultation session and possible pharmacotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Foundation for Women's Health
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.