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NCT05125146
Investigating the Effectiveness of E-CBTi Compared to Pharmaceutical Interventions in Treating Insomnia
NA trial testing e-CBTi in Insomnia in 60 participants. Currently enrolling.
21 May 2025
Quick facts
| Lead sponsor | Dr. Nazanin Alavi |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 November 2021 |
| Primary completion | 21 May 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- e-CBTi
- Trazodone (trazodone) — full drug profile →
Conditions studied
- Insomnia — all drugs for Insomnia →
Sponsor
Dr. Nazanin Alavi
Who can join
18 and older, any sex, with Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Insomnia is defined as the inability to fall asleep or stay asleep at night and it is one of the most prevalent sleep disorders that can have deleterious impacts on health and this population's quality of life. Currently, both pharmaceutical interventions (trazodone) and cognitive behavioral therapy (CBTi) are widely used to treat patients with insomnia. Although CBTi has been efficacious in many patients, multitude of barriers for receiving treatment such as its limited availability of therapists, high costs and long wait times challenge its ability in sufficiently meeting the population's health needs and demands. To improve the delivery of CBT, electronically delivered CBTi (e-CBTi) has been developed as an accessible and effective alternative intervention for improving sleep outcomes in patients with insomnia. While evidence suggest that e-CBTi is effective when compared to placebos/waitlist control, evidence comparing guided e-CBTi to pharmaceutical interventions is still insufficient and needs further exploration.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Investigating the effectiveness of electronically delivered cognitive behavioural therapy (e-CBTi) compared to pharmaceutical interventions in treating insomnia: Protocol for a randomized controlled trial.
Zhu Y, Stephenson C, Moghimi E, Jagayat J, et al · · 2023 · cited 6× · PMID 37192176 · DOI 10.1371/journal.pone.0285757
Verify or expand the search:
- PubMed search for NCT05125146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Insomnia
Currently open trials in the same condition.
- NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
- NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
- NCT07071324 — CF Wellness Program · NA · recruiting
- NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
- NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting
Other Dr. Nazanin Alavi trials
Trials by the same sponsor.
- NCT06865066 — Internet-Delivered Cognitive Behaviour Therapy for Women with Perimenopausal Anxiety · NA · recruiting
- NCT05648175 — Comparing Clinical Decision-making of AI Technology to a Multi-professional Care Team in ECBT for Depression · NA · recruiting
- NCT05579210 — Online Relapse Prevention Therapy for Patients With Alcohol Use Disorder · NA · completed
- NCT05754723 — Using an Online Psychotherapy Program and AI-assisted Interventions for Postsecondary Student Mental Health · NA · withdrawn
- NCT04747873 — Incorporating Stepped Care Approach Into e-CBT for Depression · NA · completed
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 NCT05125146 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Nazanin Alavi
- Last refreshed: 18 October 2024
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/NCT05125146.
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