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NCT06211075
Cracking the Code to Better Sleep: A Pioneering Study on Remote Support for Insomnia Relief
NA trial testing Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing in Insomnia in 30 participants. Completed in 20 March 2025.
27 November 2024
Quick facts
| Lead sponsor | Overcome |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 24 February 2024 |
| Primary completion | 27 November 2024 |
| Estimated completion | 20 March 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing
Conditions studied
- Insomnia — all drugs for Insomnia →
Sponsor
Overcome
Who can join
Adults 18 to 64, any sex, with Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goals of this clinical trial are to assess the feasibility of an internet-based Cognitive Behavioral Therapy for Insomnia (CBT-I) and Motivation Interviewing (MI) intervention for individuals aged 18 to 64 with mild to moderate insomnia, and/or mild anxiety/depression. The main questions it aims to answer are: * Can internet-based CBT-I effectively improve sleep quality and reduce insomnia symptoms? * Can internet-based CBT-I effectively improve sleep efficiency, sleep onset latency (SOL), and wake after sleep onset (WASO)? * Is CBT-I treatment feasible to carry out remotely? What are the percentages of participants who dropped out of the study? * Is internet-based CBT-I financially feasible compared to the traditional CBT-I intervention? Eligible participants would be invited to participate in the research and randomised into two groups: Intervention and Waitlist Control. Both groups will have their baseline Insomnia Severity Index and Sleep Condition Indicator assessed prior to the main part of the research. Participants in the Intervention group will go through 4 CBT-I sessions over the course of 4 weeks. These sessions will be delivered online by trained lay-person coaches, supervised directly by an experienced coach specialising in CBT-I. The Intervention group will also keep a sleep diary. At the end of the intervention, the investigators will interview 10 individuals to learn more about their experiences during the study. Participants in the Waitlist Control Group will receive the same intervention after the end of the study. This group acts as a control for the Intervention group.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06211075
- 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.
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- 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 Overcome trials
Trials by the same sponsor.
- NCT06814197 — Overcoming Procrastination in Adults: A Waitlist-Controlled Trial of One-to-One Online Coaching With Trained Volunteers · NA · completed
- NCT06544057 — Real-time eCounselling for Nicotine Addiction · NA · recruiting
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 NCT06211075 (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 Overcome
- Last refreshed: 2 July 2025
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/NCT06211075.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing