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NCT05456607 · ClinicalTrials.gov registry record · NA
Digital CBT for Insomnia and Depression
A NA study of Depression and Insomnia, sponsored by University of Rochester.
- Recruiting
- Registry status
- NA
- Development phase
- 1,500
- Enrollment target
- 1
- Study location
NCT05456607: Recruiting NA study of Depression and Insomnia, sponsored by University of Rochester.
NCT05456607 is a NA study of Depression and Insomnia that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 1,500 participants, above the 784-participant average among 679 other Depression trials with a reported enrollment target (91% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05456607, a NA study of Depression and Insomnia, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,500 participants
- Enrollment target
- 1
- Study location
Study Summary
This study has two primary objectives, each of which addresses critical clinical and research gaps for individuals who have co-occurring insomnia and depression. The first objective is to address whether sequential treatment of insomnia and depression is superior to a single treatment for either depression or for insomnia, and if so, which treatment sequence is optimal. The second objective is to determine if there are heterogeneity of treatment effects; that is, variation in which interventions are best for which individuals, and if so, to develop and individualized intervention rule to better match individuals with the treatment that is most likely to lead to the best outcomes. A large randomized trial will be conducted to meet these objectives.
Primary Outcome
The proportion of participants achieving dual remission in each study arm with Depression Remission defined as a total score of \< 5 on the Patient Health Questionnaire (PHQ-9) and Insomnia Remission defined as a total score of \< 8 on the Insomnia Severity Index (ISI).
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
- BEHAVIORAL Cognitive Behavioral Therapy for Depression
- BEHAVIORAL Mood Monitoring
Study Locations (1)
New York
- University of Rochester Sleep Research Laboratory - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2027-09-30 |
| Phase | NA |
What NCT05456607 shows while recruiting
NCT05456607 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 784-participant average among 679 other Depression trials with a reported enrollment target (91% higher).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Cognitive Behavioral Therapy for Insomnia is the first listed.
NCT05456607 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05456607 about?
NCT05456607 is a clinical study titled "Digital CBT for Insomnia and Depression". This study has two primary objectives, each of which addresses critical clinical and research gaps for individuals who have co-occurring insomnia and depression. The first objective is to address whether sequential treatment of insomnia and depression is superior to a single treatment for either dep...
What is the current status of trial NCT05456607?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,500 participants. The study started on 2023-05-01. Estimated completion is 2027-09-30.
What conditions does trial NCT05456607 study?
This clinical trial studies the following conditions: Depression, Insomnia.
What interventions are being tested in trial NCT05456607?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL), Cognitive Behavioral Therapy for Depression (BEHAVIORAL), Mood Monitoring (BEHAVIORAL).
Who is sponsoring clinical trial NCT05456607?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05456607 being conducted?
This trial has 1 study location across New York. 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 NCT05456607's enrollment target sits among peer trials
1,500 28th of 679 higher than 651 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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