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Completed

NCT Number: NCT06439420

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

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.

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Key information

Conditions

Primary Brain Tumor Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Dyssomnias Glioblastoma Glioma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Meningeal Neoplasms Meningioma Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Oligodendroglioma Primary Central Nervous System (CNS) Lymphoma Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

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.

Primary outcomes

  1. Rate of consent to screening procedures

    Time frame: Baseline (Day 1)

    Number of participants that consent to screening procedures

  2. Rate of those eligible enrolling

    Time frame: Baseline (Day 1)

    Number of participants that are eligible to enroll to the protocol

  3. Rate of baseline assessment completion

    Time frame: Week 1

    Number of participants that complete the baseline assessment

  4. Rate of post-intervention assessment completion

    Time frame: Week 6

    The number of participants that complete the post-intervention assessment

  5. Rate of follow-up assessment completion

    Time frame: Week 18

    The number of participants that complete the follow-up assessment

  6. Rate of intervention attrition

    Time frame: Week 6

    The number of participants that do not complete the CBT-I intervention

  7. Acceptability of quantity of assessments

    Time frame: Week 18

    Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best

  8. Acceptability of timing of assessments

    Time frame: Week 18

    Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best

  9. Acceptability of duration of assessments

    Time frame: Week 18

    Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Acronym: CBT-I in PBT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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