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NCT05456607
Digital CBT for Insomnia and Depression
NA trial testing Cognitive Behavioral Therapy for Insomnia in Depression in 1,500 participants. Currently enrolling.
31 March 2027
Quick facts
| Lead sponsor | University of Rochester |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 1,500 |
| Start date | 1 May 2023 |
| Primary completion | 31 March 2027 |
| Estimated completion | 18 September 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cognitive Behavioral Therapy for Insomnia
- Cognitive Behavioral Therapy for Depression
- Mood Monitoring
Conditions studied
- Depression — all drugs for Depression →
- Insomnia — all drugs for Insomnia →
Sponsor
University of Rochester
Who can join
18 and older, any sex, with Depression or Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05456607
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Rochester trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05456607 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Rochester
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05456607.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing