NCT05456607 · University of Rochester
Digital CBT for Insomnia and Depression
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia consists of the standard features of this well-established insomnia treatment that will be delivered in this study via a mobile optimized web app. Participants also have access to an intervention coach/guide as needed.
BEHAVIORAL
Cognitive Behavioral Therapy for Depression
Cognitive Behavioral Therapy for Depression consists of the standard features of this well-established depression treatment that will be delivered in this study via a mobile optimized web app. Participants also have access to an intervention coach/guide as needed.
BEHAVIORAL
Mood Monitoring
The mood monitoring intervention is based on mood tracking principles in broader mood management interventions, but without any psychoeducational content or cognitive-behavioral exercises. Instead, participants will get access to a mobile optimized web app that allows users to enter their mood, tag related events, and view trends over time to raise awareness of how activities influence certain mood states.
Primary outcome measures
Dual Remission of Depression and Insomnia
Time frame: 3 Months post-treatment
The proportion of participants achieving dual remission in each study arm with Depression Remission defined as a total score of \< 5 on the Patient Health Questionnaire (PHQ-9) and Insomnia Remission defined as a total score of \< 8 on the Insomnia Severity Index (ISI).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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
- Rochester, New York
Collaborators
United States Department of Defense, University of South Florida, Harvard University, University of California, Irvine
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations