Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05456607

Digital CBT for Insomnia and Depression

Led by University of Rochester · Updated on 2026-05-11

1200

Participants Needed

1

Research Sites

228 weeks

Total Duration

On this page

Sponsors

U

University of Rochester

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Digital CBT for Insomnia and Depression

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking
  • U.S. Military Veterans
  • Endorse depression with a Patient Health Questionnaire-depression score greater than 10
  • Endorse insomnia with an Insomnia Severity Index score greater than 10
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Rochester Sleep Research Laboratory

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

W

Wilfred Pigeon, PhD

CONTACT

M

Michelle Carr, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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