HARMONY

Health And Response: Digital Markers for Outcomes in PeriNatal Depression Treatment StudY

The UCLA Depression Grand Challenge is recruiting women to participate in a research study.

The purpose of this study is to investigate whether the addition of digital sensing data collected from smartphones and smartwatches during the early stages of perinatal depression (PND) can help predict treatment outcomes.

Adult women who are between their last trimester of pregnancy (28 weeks gestation) through postpartum period (12 weeks after delivery) and who are experiencing moderate-to-severe depression may be eligible to participate. Women must also own an eligible iPhone and have access to reliable Wifi and data plan.

If you own an Apple Watch Series 8 or newer, you can use your own watch for study participation; if you do not own an eligible Apple Watch, one will be provided to you for use in the study.* To learn more about how to determine whether your phone is eligible, click here.

What you would be asked to do if you participate:

  • Complete a number of self-report surveys online at the beginning of the study
  • Complete an onboarding session with a member of our study team via video conference
  • Install a study application on your iPhone during the onboarding session
  • For the first four weeks of the study:
    • wear the Apple Watch daily, which includes wearing it for at least 20 hours each day (including while sleeping)
    • follow daily charging requirements for your iPhone and Apple Watch
  • Report on symptoms weekly
  • Complete self-report surveys online at the middle and end of the study
Study overview

Study participation also includes engaging in one of two treatment interventions, depending on your symptoms of depression at study entry.

If you are experiencing moderate symptoms of depression and no current suicidality, you will be offered coach-guided, digital cognitive behavioral therapy (CBT) tailored to PND.
If you are experiencing severe depression or suicidality, you will be offered clinician delivered CBT.

Treatment starts with an initial orientation session conducted over video conference, followed by weekly sessions as clinically determined, for up to 12 weeks.

Study participation is expected to require a total of approximately 4.5 hours over approximately 13 weeks.

You can earn up to $200 for completing all study assessments, which includes completing surveys at the beginning, middle and end of the study; completing weekly mood ratings for the duration of the study; and wearing the watch and following charging requirements during the first four weeks of the study.

You may be able to keep the Apple Watch, if one is provided to you, depending on the amount of assessments completed.

If you previously participated in the "New Moms Mood Tracking & Wellbeing Study" study (IRB #20-001924) conducted by this UCLA research team, you are not eligible to participate in the HARMONY study.

Participating or not participating in this research will not affect the healthcare you receive from your doctor. Participation is entirely voluntary.

The possible benefits you may experience from being in this study include improvement in depressive symptoms. However, a response to treatments offered cannot be guaranteed in any patient and neither the degree of response nor the duration of response to one of the treatments offered can be reliably predicted at this time.

In order to determine if you are eligible, you will be asked to answer a series of questions about yourself and to answer questions about current symptoms of depression that you may be experiencing. If you are eligible based on your responses, you will be directed to our enrollment page, where you will have an opportunity to read the consent form before deciding to enroll. You will also be asked to sign a HIPAA Authorization for research form, which allows the UCLA study team to access information from your UCLA Health medical record for research purposes at this time.

If you are not eligible to enroll at this time based on your responses, you will be asked whether you would like to be contacted for future research opportunities.

If you are eligible, after you provide consent (if you choose to do so) and enroll in the study, you will be asked additional questions to prepare for your initial onboarding session and so we can send a study kit to your mailing address.

If a page remains idle, you will be logged out. You can re-enter your email and phone number, and verify your number via text message, to resume.

For a list of Frequently Asked Questions, click here.

To continue, please select Next.

The Apple Watch provided is a Series 8 or newer. Color and size are based on available inventory.