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Trial Title:
CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
NCT ID:
NCT06439420
Condition:
Primary Brain Tumor
Glioblastoma
Astrocytoma
Oligodendroglioma
Meningioma
Primary Central Nervous System (CNS) Lymphoma
Conditions: Official terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Meningioma
Oligodendroglioma
Conditions: Keywords:
Brain Tumor
Insomnia
Glioma
Sleep
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive Behavioral Therapy for Insomnia
Description:
CBT-I is a non-pharmacological approach to treating sleep disturbance consisting of
educational, behavioral, and cognitive intervention components with evidence-based
strategies including sleep efficiency, stimulus control, and sleep hygiene modification.
CBT-I includes at least 6 group sessions, each approximately 90 minutes in length,
delivered over 6 weeks via telehealth.
Arm group label:
Telehealth Cognitive Behavioral Therapy for Insomnia
Summary:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashlee Loughan, PhD
Phone:
804-828-4178
Email:
ashlee.loughan@vcuhealth.org
Investigator:
Last name:
Ashlee Loughan, PhD
Email:
Principal Investigator
Start date:
July 8, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Virginia Commonwealth University
Agency class:
Other
Source:
Virginia Commonwealth University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06439420
