Effectiveness of a Guided, Web-based, Stepped-care-approach to Cognitive Behavioral Therapy for Insomnia in Cancer Survivors
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Vrije Universiteit Brussel
- Trial code
- NCT07876661
- Record updated
- 15 October 2026
- Original description
The goal of this multicenter randomized clinical trial is to develop and evaluate a web-based stepped-care approach to Cognitive Behavioral Therapy for Insomnia (CBT-I), specifically tailored to adult cancer survivors experiencing insomnia. Participants will be randomly assigned to one of three study arms: stepped-care web-based CBT-I (eSTEPCBT-I), standardized web-based CBT-I (eSTANDCBT-I), or care as usual (CAU). The study aims to determine whether a stepped-care approach can improve access to effective insomnia treatment while maintaining clinical effectiveness and cost-effectiveness.Read full original descriptionShow less
eNightfall-project: Effectiveness of a Guided, Web-based, Stepped-care-approach to Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: a Multicenter Randomized Controlled Clinical Trial.
The goal of this multicenter randomized clinical trial is to develop and evaluate a web-based stepped-care approach to Cognitive Behavioral Therapy for Insomnia (CBT-I), specifically tailored to adult cancer survivors experiencing insomnia. Participants will be randomly assigned to one of three study arms: stepped-care web-based CBT-I (eSTEPCBT-I), standardized web-based CBT-I (eSTANDCBT-I), or care as usual (CAU). The study aims to determine whether a stepped-care approach can improve access to effective insomnia treatment while maintaining clinical effectiveness and cost-effectiveness.
Inclusion: Adult cancer survivors (all cancer types), who are cancer-free and have completed primary cancer treatment (radiotherapy, chemotherapy, and surgery) ≥ 3 months prior; Age ≥ 18 years; Sufficient proficiency in Dutch reading and comprehension; Insomnia Severity Index (ISI) score ≥ 12; Co-occurring sleep disorders permitted, provided they are adequately treated (e.g., obstructive sleep apnea managed with CPAP); Concurrent use of (sleep) medication permitted.
Exclusion: Prior receipt of psychological treatment targeting insomnia (CBT-I); Presence of active cancer or ongoing cancer treatment (except immunotherapy or hormonal therapy); Severe psychiatric disorders (e.g., diagnosis of bipolar disorder or schizophrenia), or significant indication as identified via the MINI-screen, that would impede trial participation; Significant indication of cognitive impairment (score of 11 or more on the 6-CIT), rendering trial participation difficult; Other untreated sleep disorders, as determined through a sleep interview and the SLAAP-50; Current pregnancy or being a parent/primary caregiver of an infant aged ≤ 6 months; Engagement in shift work during the past 3 months or planned shift work within the upcoming 15 months.