Clinical trial · Interventional
Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors
Programa Online De Intervenção Cognitivo-Comportamental Para O Tratamento Da Insónia Em Sobreviventes Oncológicos
NCT04898855CI-TRIAL-00081450completedN/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)
The main purpose of this study is to determine the treatment effects and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of Portuguese cancer survivors with insomnia.
Conditions
Conditions (3)
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 |
| Cancer Survivors | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia)
- description
- Participants assigned to the experimental group receive immediate access to the OncoSleep program, a web-based self-guided cognitive-behavioral intervention for insomnia consisting of 6 weekly sessions. A certified psychologist will monitor the participant's progress and provide feedback.
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- type
- NO_INTERVENTION
- label
- waitlist control
- description
- Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks.
Primary outcomes (1)
- measure
- Insomnia severity
- timeFrame
- Changes from baseline to post-intervention (8 weeks after randomization)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18+ years * Provided informed consent * Ability to read and write in Portuguese * Ability to use a computer and/or smartphone, and the internet * History of cancer * Having completed primary cancer treatment (survivors who are on hormone and/or other long-term maintenance therapy agencies are eligible to participate) * Subclinical or significant symptoms of insomnia (ISI scores\>=8) * Ongoing sleep medication accepted if the dosage has been stable during the last 4 weeks Exclusion Criteria: * Age ≤ 18 years * Another unstable condition (e.g., sleep, psychiatric or medical condition) * Pregnancy or breastfeeding * Concurrent CBT-I * Habitual night shift, or rotating shift-workers
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
- DERIVEDClara MI, van Straten A, Savard J, Canavarro MC, Allen Gomes A. Web-based cognitive-behavioral therapy for insomnia in cancer survivors: The OncoSleep randomized trial. Sleep Med. 2025 May;129:67-74. doi: 10.1016/j.sleep.2025.02.021. Epub 2025 Feb 18. PMID 39987779