Health And Response: Digital Markers for Outcomes in Perinatal Depression Treatment Study (HARMONY)
4 maja 2026 zaktualizowane przez: Michelle Craske, University of California, Los Angeles
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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Typ studiów
Interwencyjne
Zapisy (Szacowany)
250
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Eliza Congdon, PhD
- Numer telefonu: (310)-339-9053
- E-mail: harmonystudy@mednet.ucla.edu
Lokalizacje studiów
-
-
California
-
Los Angeles, California, Stany Zjednoczone, 90095
- University of California, Los Angeles
-
Główny śledczy:
- Nelson Freimer, MD
-
Kontakt:
- Eliza Congdon
- Numer telefonu: (310)-339-9053
- E-mail: harmonystudy@mednet.ucla.edu
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Tier 2 - PND Digital Therapy with Coaching
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 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.
|
|
Aktywny komparator: Tier 3 - Clinical Care
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. |
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS) total score
Ramy czasowe: From enrollment through the twelve weeks of the study.
|
Self-reported depression symptom severity scores
|
From enrollment through the twelve weeks of the study.
|
|
Percent change in EPDS scores
Ramy czasowe: From enrollment through the twelve weeks of the study.
|
Percent change in self-reported depression symptom severity scores (as measured with EPDS)
|
From enrollment through the twelve weeks of the study.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Treatment retention, as defined by number of coaching or therapy sessions attended by participants
Ramy czasowe: From week 2 through week 13 of the study
|
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
|
|
Treatment retention, as defined by whether the participant completed treatment or not
Ramy czasowe: From week 2 through week 13 of the study
|
Measure of treatment retention, as defined by whether the participant completed treatment or not
|
From week 2 through week 13 of the study
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Michelle G Craske, PhD, University of California, Los Angeles
- Główny śledczy: Nelson Freimer, MD, University of California, Los Angeles
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
5 maja 2026
Zakończenie podstawowe (Szacowany)
1 maja 2027
Ukończenie studiów (Szacowany)
1 maja 2027
Daty rejestracji na studia
Pierwszy przesłany
3 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 maja 2026
Pierwszy wysłany (Rzeczywisty)
11 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
4 maja 2026
Ostatnia weryfikacja
1 kwietnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 25-2121
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .