Clinical trial · Interventional
RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive Impairment | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioral | — | UNRESOLVED |
| Sleep hygiene education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group (group 1)
- description
- Participants will receive individualized digital CBT-I through an app called Hvil®. Treatment will take 6-9 weeks.
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
- type
- ACTIVE_COMPARATOR
- label
- Active control group (group 2)
- description
- Participants will receive the sleep hygiene education component of CBT-I through Hvil®. Treatment will take 6-9 weeks.
- interventionNames
- Behavioral: Sleep hygiene education
Primary outcomes (2)
- measure
- Conners continuous performance test 3rd edition
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Other sleep disorders than insomnia that may confound sleep and/or cognitive function * Use of drugs impacting that may confound sleep and/or cognitive function (endocrine therapies allowed) * Neurodegenerative and psychiatric disorders that may confound sleep and/or cognitive function * Shift work * Pregnancy or maternity leave * Recurrence of BC or new cancer * Insufficient Danish proficiency * Substance abuse that may confound sleep and/or cognitive function * Previous experience with CBT-I * Other cancer than breast cancer
References
Publications (0)
Data not yet available