Digital CBT for Insomnia and Depression
Optimizing Digital Behavioral Treatment for Co-occurring Insomnia and Depression
1 other identifier
interventional
1,500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started May 2023
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 18, 2027
April 13, 2026
June 1, 2025
3.9 years
July 5, 2022
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
3 Months post-treatment
Secondary Outcomes (2)
Depression Response
3 Months post treatment
Insomnia Response
3 Months post treatment
Study Arms (5)
Control
ACTIVE COMPARATOROnline Mood Monitoring for 12 weeks
Single Insomnia Treatment
EXPERIMENTALCognitive-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.
Single Depression Treatment
EXPERIMENTALCognitive-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.
Sequenced Depression and Insomnia Treatment
EXPERIMENTALCognitive-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.
Sequenced Insomnia and Depression Treatment
EXPERIMENTALCognitive-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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- English-speaking
- U.S. Military Veterans
- endorse depression (Patient Health Questionnaire-depression score \> 10)
- endorse insomnia (Insomnia Severity Index score \> 10).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- University of South Floridacollaborator
- United States Department of Defensecollaborator
- Harvard Universitycollaborator
- University of California, Irvinecollaborator
Study Sites (1)
University of Rochester Sleep Research Laboratory
Rochester, New York, 14642, United States
Related Publications (1)
Pigeon WR, Bishop TM, Bossarte RM, Schueller SM, Kessler RC. A two-phase, prescriptive comparative effectiveness study to optimize the treatment of co-occurring insomnia and depression with digital interventions. Contemp Clin Trials. 2023 Sep;132:107306. doi: 10.1016/j.cct.2023.107306. Epub 2023 Jul 28.
PMID: 37516163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilfred Pigeon, PhD
University of Rochester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
July 5, 2022
First Posted
July 13, 2022
Study Start
May 1, 2023
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
September 18, 2027
Last Updated
April 13, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- 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.
- 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
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.