DepressionNCT05456607
Digital CBT for Insomnia and Depression
A study testing Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Depression and Mood Monitoring in people with Depression and Insomnia, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Depression and Mood Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,175 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Sleep Research Laboratory
Rochester, New York, 14642
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Depression, Mood Monitoring
- Keywords
- cognitive behavioral therapy, digital intervention, depression, insomnia
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
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 DepressionBehavioural
Also called CBT-D
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 MonitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Online Mood Monitoring for 12 weeks Receives: Behavioral: Mood Monitoring |
| Single Insomnia Treatment | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Single Depression Treatment | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy for Depression |
| Sequenced Depression and Insomnia Treatment | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Cognitive Behavioral Therapy for Depression |
| Sequenced Insomnia and Depression Treatment | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Cognitive Behavioral Therapy for Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 Months post-treatment
Secondary outcomes (2)
Depression Response
The proportion of participants achieving a Depression treatment response defined as a ≥ 5 point reduction in the total PHQ-9 score
Measured: 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
Measured: 3 Months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 May 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of South Florida, Harvard University, University of California, Irvine
- Responsible party
- Principal investigator, Wilfred Pigeon, PhD, University of Rochester
- Investigators
- Wilfred Pigeon, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456607
- Sponsor's protocol ID
- STUDY00007379
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37516163