Health and Response: Digital Markers for Outcomes in Perinatal Depression Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses STAND for PND, a digital, coach-guided cognitive-behavioral therapy delivered online to pregnant or recently postpartum women with moderate-to-severe depression. Over up to 12 weeks, participants receive the digital therapy and clinical care, while digital sensing data from mobile devices and wearables are collected to see if they improve outcome prediction beyond self-reported symptoms. No direct comparison to standard care is made for efficacy; the goal is to see if digital markers can enhance monitoring and personalized care. Eligible participants are adults 18+, between 28 weeks gestation and 12 weeks postpartum, with EPDS ≥11, English literacy, and access to an iPhone and reliable data connectivity, and who are willing to wear an Apple Watch most of the day initially. The study is led by UCLA with collaborator Foundation for Women's Health at UCLA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least 18 years of age
* Able to read and communicate in English
* Between 28 weeks pregnant and 12 weeks postpartum
* Moderate-to-severe depression, as defined by Edinburgh Postnatal Depression Scale (EPDS) score ≥11
* Not currently seeing a provider for mental health care
* Own functioning iOS smartphone (iPhone 11 or newer, iOS 18 or newer) with access to reliable data plan and Wifi)
* Able to read and understand a written informed consent form
* Willingness to participate in treatment through the study and follow all study procedures, including providing HIPAA Authorization for research, installing a study app on personal iPhone, and wearing the provided Apple Watch for at least 20 hours every day in the first four weeks of the study (including while sleeping)

Exclusion Criteria:

* Currently receiving treatment by a therapist or a psychiatrist
* Unstable suicidality (e.g., 2 or more suicide attempts or self-injurious behaviors resulting in hospitalization in the last 6 months)
* Current substance use disorder that interferes with treatment: specifically, patients meeting diagnostic criteria for Substance Use Disorder (SUD) will be eligible for inclusion only if they are able to attend sessions while not under the influence of that substance, with the exception of individuals abusing opiates or freebase cocaine, who will be excluded
* Principal diagnosis of psychosis unrelated to depression (unipolar or bipolar)
* Neurological conditions
* Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)
* Cognitive impairment (e.g., developmental disability, dementia)
* Previously participated in the UCLA Depression Grand Challenge "New Moms Mood Tracking \& Wellbeing Study" (IRB #20-001924)

Where it's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Nelson Freimer, MD — University of California, Los Angeles
• Study coordinator: Eliza Congdon, PhD
• Email: harmonystudy@mednet.ucla.edu
• Phone: (310)-339-9053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.