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NCT05596318 · ClinicalTrials.gov registry record · NA
Perinatal Research on Improving Sleep and Mental Health
A NA study of Depression and Insomnia, sponsored by University of California, San Francisco.
- Active
- Registry status
- NA
- Development phase
- 456
- Enrollment target
- 1
- Study location
NCT05596318: Active NA study of Depression and Insomnia, sponsored by University of California, San Francisco.
NCT05596318 is a NA study of Depression and Insomnia that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 456 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05596318, a NA study of Depression and Insomnia, is active but no longer recruiting, sponsored by University of California, San Francisco.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 456 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are: 1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression? 2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement? 3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity? Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.
Primary Outcome
This is a binary outcome that measures whether a participant experienced a depressive episode at any point since randomization.
Conditions Studied
Interventions
- DEVICE Digital CBT-I
- DEVICE Digital SHE
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2022-11-02 |
| Est. Completion | 2027-04-30 |
| Phase | NA |
What the registry record for NCT05596318 still lists
NCT05596318 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (42% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Digital CBT-I is the first listed.
NCT05596318 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05596318 about?
NCT05596318 is a clinical study titled "Perinatal Research on Improving Sleep and Mental Health". The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are: 1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal dep...
What is the current status of trial NCT05596318?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 456 participants. The study started on 2022-11-02. Estimated completion is 2027-04-30.
What conditions does trial NCT05596318 study?
This clinical trial studies the following conditions: Depression, Insomnia.
What interventions are being tested in trial NCT05596318?
The interventions under investigation include: Digital CBT-I (DEVICE), Digital SHE (DEVICE).
Who is sponsoring clinical trial NCT05596318?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05596318 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05596318's enrollment target sits among peer trials
456 96th of 679 higher than 583 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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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