RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
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- Who runs it
- Aarhus University Hospital
- Trial code
- NCT06553235
- Record updated
- 8 January 2025
- Original description
The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). The study will also explore if CBT-I is associated with changes in the brain and in inflammation. The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years.Read full original descriptionShow less
The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). The study will also explore if CBT-I is associated with changes in the brain and in inflammation. The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years.
Inclusion: Age ≥18 years; Have completed primary breast cancer (BC) treatment within 1-5 years (endocrine therapies allowed); Insomnia: a score of >10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder; Cognitive impairment: a score of "quite a bit" or "very much" on at least 1 of the 2 items measuring concentration and memory on The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30) and/or <54 on the Cancer Therapy-Cognitive (FACT-Cog) perceived cognitive impairment (PCI) subscale.
Exclusion: Use of drugs impacting that may confound sleep and/or cognitive function (endocrine therapies allowed); Previous experience with CBT-I; Other sleep disorders than insomnia that may confound sleep and/or cognitive function; Neurodegenerative and psychiatric disorders that may confound sleep and/or cognitive function; Recurrence of BC or new cancer; Other cancer than breast cancer; Shift work; Pregnancy or maternity leave; Insufficient Danish proficiency; Substance abuse that may confound sleep and/or cognitive function.