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Digital CBT for Insomnia and Depression

RECRUITINGN/ASponsored by University of Rochester
Actively Recruiting
PhaseN/A
SponsorUniversity of Rochester
Started2023-05-01
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

DepressionInsomnia

Locations1 site

University of Rochester Sleep Research Laboratory
Rochester, New York, 14642
Wilfred Pigeon, Ph.D.585-275-2900wilfred_pigeon@urmc.rochester.edu

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