Digital CBT for Insomnia and Depression
Recruiting · NCT05456607 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Rochester
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- University of Rochester Sleep Research Laboratory - Rochester, New York, United States