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| Name | Class |
|---|---|
| Foundation for Women's Health | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tier 2 - PND Digital Therapy with Coaching | Active Comparator | 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. |
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| Tier 3 - Clinical Care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perinatal depression online cognitive-behavioral therapy course | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Edinburgh Postnatal Depression Scale (EPDS) total score | Self-reported depression symptom severity scores | From enrollment through the twelve weeks of the study. |
| Percent change in EPDS scores | Percent change in self-reported depression symptom severity scores (as measured with EPDS) | From enrollment through the twelve weeks of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment retention, as defined by number of coaching or therapy sessions attended by participants | Measure of treatment retention, as defined by number of coaching or therapy sessions attended. A participant is considered to have been retained in treatment if they completed number of sessions advised by their therapist, or to have not been categorized as dropping from treatment early. | From week 2 through week 13 of the study |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eliza Congdon, PhD | Contact | (310)-339-9053 | harmonystudy@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nelson Freimer, MD | University of California, Los Angeles | Principal Investigator |
| Michelle G Craske, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2025 | Mar 12, 2026 |
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| Clinical care (psychotherapy sessions) | Behavioral | 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. |
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| Treatment retention, as defined by whether the participant completed treatment or not | Measure of treatment retention, as defined by whether the participant completed treatment or not | From week 2 through week 13 of the study |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 16, 2026 | Apr 27, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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