Digital CBT for Insomnia and Depression

May 5, 2026 updated by: Wilfred Pigeon, PhD, University of Rochester

Optimizing Digital Behavioral Treatment for Co-occurring Insomnia and Depression

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Online Mood Monitoring for 12 weeks
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.
Experimental: Single Insomnia Treatment
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 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.
Other Names:
  • CBT-I
Experimental: Single Depression Treatment
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 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.
Other Names:
  • CBT-D
Experimental: Sequenced Depression and Insomnia Treatment
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
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.
Other Names:
  • CBT-I
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.
Other Names:
  • CBT-D
Experimental: Sequenced Insomnia and Depression Treatment
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
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.
Other Names:
  • CBT-I
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.
Other Names:
  • CBT-D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 Months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Response
Time Frame: 3 Months post treatment
The proportion of participants achieving a Depression treatment response defined as a ≥ 5 point reduction in the total PHQ-9 score
3 Months post treatment
Insomnia Response
Time Frame: 3 Months post treatment
The proportion of participants achieving an Insomnia treatment response defined as a ≥ 8 point reduction in the total ISI score
3 Months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

University of South Florida
United States Department of Defense
University of California, Irvine
Harvard University

Investigators

  • Principal Investigator: Wilfred Pigeon, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 18, 2027

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

A final dataset and codebook will be submitted to the the Inter-university Consortium for Political and Social Research (ICPSR) at the conclusion of the study and will remain available in accordance with ICPSR guidelines.

IPD Sharing Access Criteria

Access criteria will be in accordance with the policies set forth by the data repository, the Inter-university Consortium for Political and Social Research (ICPSR), which are available at: https://www.icpsr.umich.edu/web/pages/datamanagement/lifecycle/access.html

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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