An interventional study of Cognitive Behavioral Therapy for Insomnia and Cognitive Behavioral Therapy for Depression in Depression and Insomnia, sponsored by University of Rochester. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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.
Although efficacious behavioral treatments like cognitive behavioral therapy for insomnia (CBT-I) and for depression (CBT-D) exist for insomnia and depression disorders, their impact on co-occurring symptoms can be modest and residual symptoms often remain. In addition, scalable versions of these interventions (like computer accessible or phone app versions) are needed for U.S. military Veterans who lack access to first-line interventions because of rural or other resource-limited environments. Finally, little is known about heterogeneity of treatment effects; that is, variation in which interventions are best for which individuals. This comparative effectiveness trial is designed to develop an an individualized intervention rule to match the right digital intervention to the right person with co-occurring insomnia and depression.
The study will use digital versions of CBT-I and CBT-D found to be efficacious for their intended target. A total of 1,160 participants who are Veterans with both insomnia and depression will be randomized with equal allocation to five study arms: two single interventions (CBT-I or CBT-D); two sequenced interventions (CBT-I+D or CBT-D+I); and a mood monitoring condition that will serve as the control group. Importantly, after approximately 400 participants have been randomized, we will end randomization to the mood monitoring condition and all subsequent participants (approximately 800) will then be randomized across the four remaining treatment conditions. Assessments occur at baseline, mid-treatment, post-treatment, at 3-month and 6-month follow-ups. The primary endpoint will be remission of both depression and insomnia at 3 months following the 12 week intervention period. All study activity will be conducted remotely including recruitment, treatment delivery and assessments, so that participants can be recruited nationwide.
The study will estimate average treatment effects on insomnia and depression remission at 3-months post-treatment (primary outcome) and 6-month maintenance of remission as well as treatment response. Significantly higher remission and response rates for sequenced rather than single interventions and lowest for the mood monitoring control condition are expected. Because variation in which interventions are best for which individuals are expected, study investigators will develop and evaluate an individualized intervention rule to determine an optimal approach for each participant in promoting 3-month remission of both disorders. A cutting-edge ensemble machine learning method will be used to do this.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Inclusion Criteria:
Exclusion Criteria are limited in accordance with real world effectiveness trials, but will include:
Online Mood Monitoring for 12 weeks
Behavioral: Mood Monitoring
Cognitive-behavioral therapy for insomnia delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.
Behavioral: Cognitive Behavioral Therapy for Insomnia
Cognitive-behavioral therapy for depression delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.
Behavioral: Cognitive Behavioral Therapy for Depression
Cognitive-behavioral therapy for depression followed by cognitive-behavioral therapy for insomnia each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the depression treatment only for 4 weeks after which the access to the insomnia treatment is also made available. Total duration of access for 12 weeks.
Behavioral: Cognitive Behavioral Therapy for Insomnia · Behavioral: Cognitive Behavioral Therapy for Depression
Cognitive-behavioral therapy for insomnia followed by cognitive-behavioral therapy for depression each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the insomnia treatment only for 4 weeks after which the access to the depression treatment is also made available. Total duration of access for 12 weeks.
Behavioral: Cognitive Behavioral Therapy for Insomnia · Behavioral: Cognitive Behavioral Therapy for Depression
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.
Also known as: CBT-I
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.
Also known as: CBT-D
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.
Dual Remission of Depression and Insomnia
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).
Time frame: 3 Months post-treatment
Depression Response
The proportion of participants achieving a Depression treatment response defined as a ≥ 5 point reduction in the total PHQ-9 score
Time frame: 3 Months post treatment
Insomnia Response
The proportion of participants achieving an Insomnia treatment response defined as a ≥ 8 point reduction in the total ISI score
Time frame: 3 Months post treatment
Plan to share: Yes — Deidentified data will be submitted to a data repository: the Inter-university Consortium for Political and Social Research (ICPSR) data repository at the University of Michigan for secondary analysis.
Supporting information: Study protocol
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Rochester