Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors
NCT ID: NCT04898855
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2023-08-19
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia)
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.
Cognitive Behavioral Therapy for Insomnia
Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
waitlist control
Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks.
No interventions assigned to this group
Interventions
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Cognitive Behavioral Therapy for Insomnia
Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Another unstable condition (e.g., sleep, psychiatric or medical condition)
* Pregnancy or breastfeeding
* Concurrent CBT-I
* Habitual night shift, or rotating shift-workers
18 Years
ALL
No
Sponsors
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Portuguese Cancer League
UNKNOWN
Fundação para a Ciência e a Tecnologia
OTHER
University of Coimbra
OTHER
Responsible Party
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Maria Inês Clara
PhD candidate
Locations
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Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)
Coimbra, , Portugal
Countries
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References
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Clara 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.
Related Links
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OncoSleep website
Other Identifiers
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2020.05728.BD
Identifier Type: -
Identifier Source: org_study_id
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