CBT-I in Primary 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.

Conditions

Primary Brain Tumor, Glioblastoma, Astrocytoma, Oligodendroglioma, Meningioma, Primary Central Nervous System (CNS) Lymphoma

Study Overview

Study Details

Study overview

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.

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

CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial

Condition
Primary Brain Tumor
Intervention / Treatment

-

Contacts and Locations

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Virginia Commonwealth University,

Ashlee Loughan, Ph.D, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2026-11-30