RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus N
Contact Information
Primary
Ali Amidi
ali@psy.au.dk
+4587165305
Backup
Julie K. Thomadsen
jtho@psy.au.dk
+4587150192
Time Frame
Start Date: 2024-12-06
Estimated Completion Date: 2030-03-28
Participants
Target number of participants: 84
Treatments
Experimental: Intervention group (group 1)
Participants will receive individualized digital CBT-I through an app called Hvil®. Treatment will take 6-9 weeks.
Active_comparator: Active control group (group 2)
Participants will receive the sleep hygiene education component of CBT-I through Hvil®. Treatment will take 6-9 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: University of Aarhus
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov