CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial (CBT-I in PBT)
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About
This study seeks to investigate an evidence-based, manualized, behavioral health intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I), in individuals with primary brain tumors (PBT) and insomnia. Our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with PBT and insomnia in the behavioral health intervention, CBT-I, and investigate the potential benefits of CBT-I within this at-risk and understudied population. In the long term, the goals are to expand treatment options for neuro-oncology patients and improve their mission readiness and overall wellbeing.
Enrollment
Sex
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Volunteers
Inclusion criteria
- Primary brain tumor diagnosis (grade I-IV)
- >/=2weeks post-cranial resection (if applicable)
- >/=1 month post-radiation therapy (if applicable)
- Able to understand, speak, and read English
- Absence of major cognitive concerns
- Meet Diagnostic and statistical manual of mental disorders version 5 (DSM-V) diagnostic criteria for insomnia
- Reliable internet connection
Exclusion criteria
- Major communication difficulties that would prohibit effective intervention
- Inability to attend weekly virtual group meetings
- Inability to understand and provide informed consent
- Currently a prisoner or residing in a correctional facility
Trial design
Primary purpose
Allocation
Interventional model
Masking
70 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Mary Bridgman
Data sourced from clinicaltrials.gov
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