Clinical trial · Interventional
CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients
Testing an Accessible Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention in Newly Diagnosed Cancer Patients
NCT02410564CI-TRIAL-00020854terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient staff
Summary
Brief summary (as posted)
To determine the efficacy of a CBT-I intervention in improving sleep and other quality of life outcomes during cancer treatment. To assess the feasibility and acceptability of a CBT-I intervention among newly diagnosed cancer patients.
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 |
| Chronic Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive behavioral therapy for insomnia (CBTI) | Behavioral | — | UNRESOLVED |
| Waitlist control condition | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CBTI treatment
- description
- cognitive behavioral therapy for insomnia (CBTI) treatment is a validated web based version of CBT-I, which will take place over seven weeks and will include a combination of face-to-face and telephone sessions, and email updates
- interventionNames
- Behavioral: cognitive behavioral therapy for insomnia (CBTI)
- type
- PLACEBO_COMPARATOR
- label
- Waitlist control condition
- description
- No advice regarding sleep will be given to the control group and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study.
- interventionNames
- Behavioral: Waitlist control condition
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * newly diagnosed with I-III non-metastatic cancer * scheduled to begin chemotherapy or radiotherapy * chemotherapy or radiotherapynaïve * meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month) * Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month. * interested in behavioral sleep treatment * have the permission of their oncologists to participate. Exclusion criteria: * untreated alcohol or substance abuse or dependence, bipolar, or psychotic disorder * medical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease * untreated sleep disorders such as sleep apnea
References
Publications (1)
- 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