Clinical trial · Interventional
The Sleepio After Cancer Study
The Sleepio After Cancer Study (SACS). Digital CBT for Insomnia in Women Cancer Patients - A Randomised Controlled Trial
NCT05816460CI-TRIAL-00066596SACSunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will recruit women over the age of 18 with a current or prior cancer diagnosis who have clinical insomnia. This study will examine the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I) compared to sleep hygiene education.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) | Other | — | UNRESOLVED |
| Sleep Hygiene Education (SHE) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
- description
- Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be provided on an online digital platform called Sleepio (BigHealth Ltd). Sleepio delivers fully automated CBT-I through 6 sessions, lasting an average of 20 minutes each, over the course of 6 weeks.
- interventionNames
- Other: Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
- type
- ACTIVE_COMPARATOR
- label
- Sleep Hygiene Education (SHE)
- description
- The Sleep Hygiene Education (SHE) provided is based on recognised sleep hygiene advice and will consist of behavioural recommendations concerning lifestyle and environmental factors associated with sleep and insomnia. SHE will be delivered electronically.
- interventionNames
- Other: Sleep Hygiene Education (SHE)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women * Aged 18 and over * Sleep Condition Indicator (SCI) score of 16 or less * Current or past diagnosis of cancer * Fluent in written and spoken English * Internet access and comfortable with its use Exclusion Criteria: * Acute Illness * Life expectancy less than 6 months * Evidence of another sleep disorder * Untreated Psychiatric Disorder * Drug Misuse * Currently receiving CBT for insomnia from a health professional or taking part in an online treatment programme for insomnia * Any condition that may be exacerbated by sleep restriction therapy (Obstructive sleep apnoea, Bipolar disorder, psychosis, schizophrenia, epilepsy, current suicidal ideation, shift work, dementia, Parkinson's disease, Lewy body dementia) * Planned Major Surgery * Commencement or a change in sleep medication within the last 4 weeks
References
Publications (2)
- DERIVEDCai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. PMID 41170811
- DERIVEDTreacy T, O'Meara Y, Galligan MC, Henry AL, Lensen SF, Higgins MJ, Hickey M, Brennan DJ. The Sleepio After Cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. Contemp Clin Trials. 2024 Jan;136:107337. doi: 10.1016/j.cct.2023.107337. Epub 2023 Sep 21. PMID 37741507