Digital CBT for Insomnia and Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

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

Qualifiers

English-speaking

U.S. Military Veterans

endorse depression (Patient Health Questionnaire-depression score > 10)

endorse insomnia (Insomnia Severity Index score > 10).

Disqualifiers

pregnancy

history of bipolar disorder

history of psychosis

current use of anti-psychotic medications or mood stabilizers (e.g., lithium)

Trial design

Treatments tested in this trial

  • Cognitive Behavioral Therapy for Insomnia
  • Cognitive Behavioral Therapy for Depression
  • Mood Monitoring

Treatment groups

1,200 Participants
are divided into 5 treatment groups

Sponsors and collaborators

University of Rochester

Lead sponsor

United States Department of Defense

Collaborator

University of South Florida

Collaborator

Harvard University

Collaborator

University of California, Irvine

Collaborator