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New treatment option for Depression
Official title Health And Response: Digital Markers for Outcomes in Perinatal Depression Treatment Study
ClinicalTrials.gov ID: NCT07577947
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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)...
- 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)
See the full eligibility 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.