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NCT02053649 · ClinicalTrials.gov registry record · NA
Integrated Chronotherapy for Perinatal Depression
A NA study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT02053649: Completed NA study, sponsored by Rhode Island Hospital.
NCT02053649 is a NA study that has completed, run by Rhode Island Hospital. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02053649, a NA study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
Perinatal depression is a common and serious mood disorder that increases morbidity and mortality in new mothers and results 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 suffer from circadian rhythm disruption are at risk for perinatal depression. This R34 Pilot Effectiveness Studies and Services Research Grant seeks to test whether an Integrated Chronotherapy (IC) intervention can be implemented in an outpatient psychiatry setting to improve treatment outcomes for patients with perinatal depression. IC 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, sleep-wake behavior, social rhythms, and arousal. We will assess the feasibility, safety, and acceptability of an IC intervention for perinatal depressin by testing the treatment in expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. We will randomize patients to either: (a) usual care (UC, n = 20) or (b) IC+UC (n = 20). IC+UC will have pregnancy and postpartum components and will be administered via an individualized case formulation approach tailored to each patient. After a baseline assessment, IC 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 administered by a perinatal psychiatrist and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the IC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self-report. We will assess the safety profile of the IC intervention with evaluation of side effects/adverse events. Importantly,
Primary Outcome
17-item Hamilton Depression score
Interventions
- OTHER Usual Care
- BEHAVIORAL Triple Chronotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-01 |
| Est. Completion | 2019-02-28 |
| Phase | NA |
What the finished NCT02053649 record still lists
NCT02053649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT02053649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02053649 about?
NCT02053649 is a clinical study titled "Integrated Chronotherapy for Perinatal Depression". Perinatal depression is a common and serious mood disorder that increases morbidity and mortality in new mothers and results 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 treatme...
What is the current status of trial NCT02053649?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2014-01. Estimated completion is 2019-02-28.
What interventions are being tested in trial NCT02053649?
The interventions under investigation include: Usual Care (OTHER), Triple Chronotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02053649?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02053649's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 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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