Recruiting

CBT-I

Sponsor:

Memorial University of Newfoundland

Code:

NCT07101302

Conditions

Insomnia

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

App-Based Cognitive Behavioural Therapy for Insomnia

Study Details

Brief summary:

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.

Conditions

Insomnia

Cancer

Study ID

NCT07101302

Start date

Nov 4, 2025

Status verified date

Feb, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Good performance status as indicated by a score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
  • Access to internet connection
  • Ownership of smartphone
  • Fluency using mobile applications.
  • Individuals with non-hematological malignancies must show no evidence of cancer or clinically stable/inactive disease for a minimum of 3 months prior to enrollment (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.
  • 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 Criteria:

  • 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.

Study Design

Enrollment

146 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Treatment

The immediate treatment group will begin the app-based insomnia intervention immediately after enrolling.

experimental: Waitlist Control

The waitlist control group will begin the app-based intervention after a waiting period of 8 weeks after enrolling.

Interventions

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.

Primary outcome measure

  • Insomnia Severity [ Time Frame: From enrollment until 3-month follow-up ]
  • Sleep Efficiency [ Time Frame: From enrollment to end of treatment at 7 weeks ]
  • Sleep-Onset Latency [ Time Frame: From enrollment to end of treatment at 7 weeks ]
  • Wake After Sleep Onset [ Time Frame: From enrollment to end of treatment at 7 weeks ]
  • Total Sleep Time [ Time Frame: From enrollment to end of treatment at 7 weeks ]

Central Contacts and Locations

Central contacts

Sheila N Garland

1 (709) 864-8035icansleepapp@gmail.com

Locations

Memorial University of Newfoundland

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3X9

Contacts

Sheila N Garland

1 (709) 864-8035icansleepapp@gmail.com

More Information

Sponsor

Memorial University of Newfoundland

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • Cancer Survivor
  • Insomnia
  • Mobile Application

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial University of Newfoundland on 2026-02-20.