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NCT05056454 · ClinicalTrials.gov registry record · NA
New Moms Mood Tracking & Wellbeing
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 166
- Enrollment target
NCT05056454: Completed NA study, sponsored by University of California, Los Angeles.
NCT05056454 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 166 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05056454, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 166 participants
- Enrollment target
Study Summary
New moms can be at risk for perinatal depression (PND). The New Moms Mood Tracking and Wellbeing study is investigating mood changes, risk factors for depression and anxiety and treatment response around the time of delivery. Participants will be asked to complete three sets of online surveys between week 28 gestation and week 20 after delivery, in addition to downloading an app to collect data using their smartphone sensors and brief symptom surveys every other week. Women with elevated symptoms will be eligible to participate in a treatment study. Women who are eligible for the treatment study will be randomized to one of two conditions - Perinatal Psychiatric Care or Screening and Treatment for Anxiety and Depression (STAND). In Perinatal Psychiatric Care, participants will receive appointments with psychiatry clinicians for medication management and supportive therapy. In STAND, participants will be allocated to Online therapy with Coaching or Clinical Care, which includes both psychotherapy and psychiatry appointments. Treatment can last up to 6 months and there will be treatment related assessments for the duration of the 6 months, in addition to brief symptom surveys on a regular basis. Therefore, participation can last between 24 and 52 weeks, as both time of delivery and treatment enrollment timepoint cannot be scheduled in advance.
Primary Outcome
Evaluation of degree of change in depression score throughout and after defined treatment periods as measured by the CAT-MH scores. The CAT-MH uses item response theory (IRT) to select a subset of items from a pool of approximately 1000 questions to target the respondent's impairment level. It consists of five modules, which screen for a diagnosis of Major Depressive Disorder, depressive symptoms, anxiety symptoms, mania, and suicidal ideation.
Interventions
- BEHAVIORAL Online therapy with coaching within STAND
- BEHAVIORAL Clinical care within STAND
- OTHER Perinatal Psychiatric Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2021-04-15 |
| Est. Completion | 2024-04-01 |
| Phase | NA |
What the finished NCT05056454 record still lists
NCT05056454 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Online therapy with coaching within STAND is the first listed.
NCT05056454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05056454 about?
NCT05056454 is a clinical study titled "New Moms Mood Tracking & Wellbeing". New moms can be at risk for perinatal depression (PND). The New Moms Mood Tracking and Wellbeing study is investigating mood changes, risk factors for depression and anxiety and treatment response around the time of delivery. Participants will be asked to complete three sets of online surveys betwee...
What is the current status of trial NCT05056454?
This trial is currently completed. It is a NA study. The enrollment target is 166 participants. The study started on 2021-04-15. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT05056454?
The interventions under investigation include: Online therapy with coaching within STAND (BEHAVIORAL), Clinical care within STAND (BEHAVIORAL), Perinatal Psychiatric Care (OTHER).
Who is sponsoring clinical trial NCT05056454?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05056454's enrollment target sits among peer trials
166 625th of 2000 higher than 1,375 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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