Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2023-05-01
2027-09-30
Brief Summary
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Detailed Description
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The study will use digital versions of CBT-I and CBT-D found to be efficacious for their intended target. A total of 1,500 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. 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. In a companion, subsequent trial with a new cohort of 800 participants, the investigators will evaluate whether assigning participants to a treatment condition via the individualized intervention rule is superior to simple randomization that does not consider individual factors in the treatment decision. This subsequent trial will be registered as a separate clinical trial, but will refer back to this current trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control
Online Mood Monitoring for 12 weeks
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* U.S. Military Veterans
* endorse depression (Patient Health Questionnaire-depression score \> 10)
* endorse insomnia (Insomnia Severity Index score \> 10).
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of South Florida
OTHER
Harvard University
OTHER
University of California, Irvine
OTHER
University of Rochester
OTHER
Responsible Party
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Wilfred Pigeon, PhD
Professor of Psychiatry
Principal Investigators
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Wilfred Pigeon, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester Sleep Research Laboratory
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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STUDY00007379
Identifier Type: -
Identifier Source: org_study_id
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