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Active Not Recruiting
NCT05456607
Digital CBT for Insomnia and Depression
Conditions: Depression, Insomnia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1200
Sponsor: University of Rochester
Location: University of Rochester Sleep Research Laboratory Rochester New York
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
Source: ClinicalTrials.gov (NCT05456607). StuddyBuddy aggregates publicly available trial information.