Actively Recruiting
RESET-BRAIN: Rehabilitation of Sleep and Cognitive Impairment in Breast Cancer Survivors Using an App-based Intervention
Led by Aarhus University Hospital · Updated on 2025-01-08
84
Participants Needed
1
Research Sites
276 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
U
University of Aarhus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether an app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive problems and sleep quality in breast cancer survivors who have completed treatment within the past 1 to 5 years. The study compares CBT-I with an active control group receiving sleep hygiene education. It also explores whether CBT-I leads to changes in brain structure and inflammation levels in this group of 84 female participants experiencing insomnia and cognitive impairment. Participants will be randomly assigned to receive either the app-based CBT-I, which includes sleep restriction, stimulus control, relaxation, cognitive therapy, and sleep hygiene education, or the sleep hygiene education alone. Both groups will complete treatment and undergo assessments after approximately 9 weeks, followed by a six-month follow-up. The study will use brain MRI scans and inflammatory marker tests to investigate possible changes in brain and immune function. Throughout the study, participants will complete cognitive tests including the Conners Continuous Performance Test and answer questionnaires such as the Insomnia Severity Index at baseline, post-treatment, and six months later. Additional neuropsychological assessments will measure cognitive function. The study will monitor treatment effects on sleep and cognition, brain changes, inflammation, and overall safety and adherence over the course of about 8 months.
CONDITIONS
Official Title
RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Completed primary breast cancer treatment within 1 to 5 years (endocrine therapies allowed)
- Insomnia defined by an Insomnia Severity Index score greater than 10 and/or meeting DSM-5 criteria for Insomnia Disorder
- Cognitive impairment defined by significant difficulties in concentration or memory on the EORTC-QLQ-C30 or a FACT-Cog perceived cognitive impairment subscale score below 54
You will not qualify if you...
- Presence of sleep disorders other than insomnia that could affect sleep or cognitive function
- Use of drugs that may affect sleep or cognitive function (except endocrine therapies)
- Neurodegenerative or psychiatric disorders that may impact sleep or cognitive function
- Currently working night shifts
- Pregnancy or maternity leave
- Recurrence of breast cancer or diagnosis of new cancer
- Insufficient proficiency in Danish
- Substance abuse that could affect sleep or cognitive function
- Previous experience with cognitive behavioral therapy for insomnia (CBT-I)
- History of cancers other than breast cancer
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus N, Denmark
Actively Recruiting
Research Team
A
Ali Amidi
J
Julie K. Thomadsen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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