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Official title RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
ClinicalTrials.gov ID: NCT06553235
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.