InsomniaNCT04898855
Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Cancer, run by University of Coimbra at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Cancer, Cancer Survivors
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Aug 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)
Coimbra
About this study
Official title: Programa Online De Intervenção Cognitivo-Comportamental Para O Tratamento Da Insónia Em Sobreviventes Oncológicos
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
- Insomnia, Cancer, Cancer Survivors
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- insomnia, cancer, CBTI, digital CBT-I, internet intervention, cancer survivors
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called OncoSleep
Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
| Study group | Role | What they receive |
|---|---|---|
| OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia) | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| waitlist control | No intervention | Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity
Insomnia Severity Index: validated questionnaire among cancer survivors; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Secondary outcomes (9)
Anxiety
Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest anxiety level)
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Depression
Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest depression level)
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Health-related quality of life
European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30; World Health Organization Quality of Life - Brief (overall scores 0-100, higher scores indicate higher quality of life)
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Cancer-related fatigue
Multidimensional Fatigue Symptom Inventory-Short Form (overall score -24-96, higher scores denote higher levels of cancer-related fatigue)
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Sleep efficiency
Sleep Diary
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Total sleep time
Sleep Diary
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Sleep onset latency
Sleep Diary
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Number of nocturnal awakenings
Sleep Diary
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Wake after sleep onset
Sleep Diary
Measured: Changes from baseline to post-intervention (8 weeks after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start19 Aug 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Portuguese Cancer League, Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Maria Inês Clara, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898855
- Sponsor's protocol ID
- 2020.05728.BD
- Status last verified
- Sep 2024
- First submitted
- 12 May 2021
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cai 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.
PubMed 41170811Clara 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.
PubMed 39987779
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programa Online De Intervenção Cognitivo-Comportamental Para O Tratamento Da Insónia Em Sobreviventes Oncológicos
- ClinicalTrials.gov ID
- NCT04898855
- Acronym / sponsor ID
- 2020.05728.BD
- Conditions
- Insomnia, Cancer, Cancer Survivors
- Keywords
- insomnia, cancer, CBTI, digital CBT-I, internet intervention, cancer survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Portuguese Cancer League, Fundação para a Ciência e a Tecnologia
- Study start
- 19 Aug 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia) | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaParticipants 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. |
| waitlist control | No intervention | –Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaAlso: OncoSleepTreatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy. | Behavioural | OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia) |
Primary outcome
Insomnia severity
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Insomnia Severity Index: validated questionnaire among cancer survivors; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
9 secondary outcomes
Anxiety
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Depression
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Health-related quality of life
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Cancer-related fatigue
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Sleep efficiency
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Total sleep time
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Sleep onset latency
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Number of nocturnal awakenings
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Wake after sleep onset
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 41170811Cai 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.
- Derived from this study: PubMed 39987779Clara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Cancer, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: Changes from baseline to post-intervention (8 weeks after randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04898855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.