NCT05456607 Digital CBT for Insomnia and Depression
| NCT ID | NCT05456607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,200 participants in total. It began in 2023-05-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * English-speaking * U.S. Military Veterans * endorse depression (Patient Health Questionnaire-depression score \> 10) * endorse insomnia (Insomnia Severity Index score \> 10). Exclusion Criteria are limited in accordance with real world effectiveness trials, but will include: * pregnancy * history of bipolar disorder * history of psychosis * current use of anti-psychotic medications or mood stabilizers (e.g., lithium) * current suicidal ideation with active intent
Contact & Investigator
Wilfred Pigeon, PhD
PRINCIPAL INVESTIGATOR
University of Rochester
Frequently Asked Questions
Who can join the NCT05456607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05456607 currently recruiting?
Yes, NCT05456607 is actively recruiting participants. Contact the research team at wilfred_pigeon@urmc.rochester.edu for enrollment information.
Where is the NCT05456607 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05456607 clinical trial?
NCT05456607 is sponsored by University of Rochester. The principal investigator is Wilfred Pigeon, PhD at University of Rochester. The trial plans to enroll 1,200 participants.
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