Testing App-Based Cognitive Behavioural Therapy for insomnia
Official title: iCANSleep: Smartphone App-Based Insomnia Treatment for Cancer Survivors
iCANSleep: A Randomized Controlled Trial of a Smartphone App-Based Insomnia Treatment for Cancer Survivors
- 2 groups
- One site, in St. John's
- Recruiting
Interventions
- Behavioural therapy
App-Based Cognitive Behavioural Therapy for Insomnia
The iCANSleep app is based on an established CBT-I protocol. The core features of the iCANSleep app include 1) a modified CBT-I protocol for cancer survivors and 2) daily sleep diaries. Core components of CBT-I treatment to be implemented include sleep restriction, stimulus control, cognitive restructuring, and psychoeducation. These components will be modified into 7-weekly modules.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Good performance status as indicated by a score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
- +Individuals with non-hematological malignancies must show no evidence of cancer or clinically stable/inactive disease for a minimum of 3 months prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → (for individuals with non-metastatic cancer) or be on a stable treatment regimen for the prior 3 months (for individuals with metastatic cancer) to ensure that insomnia is not a direct, acute response to cancer treatment.
- +Cancer survivors
- +Over 18 years of age
- +Lives in Canada
- +Understands English or French fluently
- +DSM-5 diagnosis of insomnia
- +ISI score of 8 or higher
- +Access to internet connection
- +Ownership of smartphone
- +Fluency using mobile applications.
- +Individuals with hematological malignancies must be in remission at the time of recruitment and have completed cancer treatments (e.g., transplant, chemotherapy, immunotherapy, radiotherapy) at least 3 months prior.
Exclusion
- −Presence of a sleep disorder other than insomnia that is not adequately treated (e.g., untreated sleep apnea)
- −Presence of a psychological disorder that is currently untreated or would impair the ability to participate (e.g., bipolar disorder)
- −Major sensory deficit (e.g., blindness)
- −Previous experience receiving CBT-I.
- −The use of medications prescribed for sleep (e.g., hypnotics, sedatives, or antidepressants) will be tracked and adjusted for in the statistical analysis.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B receive App-Based Cognitive Behavioural Therapy for Insomnia.
Registry label: A: Immediate Treatment · B: Waitlist Control
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 146 people.
The study is currently expected to finish around November 2026.
The main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → until 3-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Insomnia Severity — measured over From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → until 3-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
Sleep Efficiency — measured over From enrollment to end of treatment at 7 weeks.
Sleep-Onset Latency — measured over From enrollment to end of treatment at 7 weeks.
Wake After Sleep Onset — measured over From enrollment to end of treatment at 7 weeks.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07101302 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About App-Based Cognitive Behavioural Therapy for InsomniaBehavioural
The iCANSleep app is based on an established CBT-I protocol. The core features of the iCANSleep app include 1) a modified CBT-I protocol for cancer survivors and 2) daily sleep diaries. Core components of CBT-I treatment to be implemented include sleep restriction, stimulus control, cognitive restructuring, and psychoeducation. These components will be modified into 7-weekly modules.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → until 3-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
The study as a whole is currently expected to finish around 2026-11.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 146 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: St. John's, Newfoundland and Labrador, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The investigators will answer the question of whether treating insomnia using the mobile-app-based intervention of Cognitive Behavioural Therapy for Insomnia (CBT-I) for cancer survivors ("iCANSleep") can improve symptoms of insomnia in Canadian cancer survivors compared to a waitlist control group. The investigators will recruit 146 people with insomnia who have completed cancer treatment at least 3 months prior to the study.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.