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Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial


Description

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.

Trial Eligibility

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

Study Info

Organization

Virginia Commonwealth University


Primary Outcome

Rate of consent to screening procedures


Outcome Timeframe Baseline (Day 1)

NCTID NCT06439420

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2024-07-08

Completion Date 2026-11-30

Enrollment Target 60

Interventions

BEHAVIORAL Cognitive Behavioral Therapy for Insomnia

Locations Recruiting

Virginia Commonwealth University

United States, Virginia, Richmond


Interested in joining this trial?

Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.

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