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NCT04364646 · ClinicalTrials.gov registry record · NA
Personalized Integrated Chronotherapy for Perinatal Depression
A NA study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT04364646 is a NA study that has completed, run by Rhode Island Hospital. The registered enrollment target is 120 participants.
The verdict
NCT04364646, a NA study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated, and many pregnant women seek non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not available. Expectant and new mothers who experience circadian rhythm dysregulation are at increased risk for perinatal depression. This Confirmatory Efficacy Clinical Trial of Non-Pharmacological Interventions for Mental Disorders R01 seeks to test whether a Personalized Integrated Chronotherapy (PIC) intervention can improve treatment outcomes for pregnant patients seeking outpatient treatment for depression, with or without anxiety. PIC is a multicomponent treatment consisting of bright light therapy, sleep phase advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC) constructs of circadian rhythms and sleep-wake behavior. To increase sample size and diversity and accelerate recruitment, this study will be performed at 4 sites that differ in clinical structure and that have piloted the PIC intervention. The study will enroll expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. Participants will be randomized to either: (a) usual care (UC, n = 110) or (b) PIC+UC (n = 110). PIC+UC will have pregnancy and postpartum components and will be administered via a personalized approach tailored to optimize the intervention based on each patient's individual circadian and sleep timing. After a baseline assessment, PIC will be prescribed during 5 dedicated clinical visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will consist of medication and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the PIC+UC and UC groups. Mood will be measured in
Interventions
- BEHAVIORAL Personalized Integrated Chronotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04364646
The ClinicalTrials.gov registry entry for NCT04364646 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Personalized Integrated Chronotherapy is the first listed.
NCT04364646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04364646 about?
NCT04364646 is a clinical study titled "Personalized Integrated Chronotherapy for Perinatal Depression". Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated, and many pregnant wo...
What is the current status of trial NCT04364646?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2020-11-02. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT04364646?
The interventions under investigation include: Personalized Integrated Chronotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04364646?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
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