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

NCT06439420 | Completed Phase 2 DMC

• 2 other identifiers: MCC-23-20323HM20028336
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Brain Tumor; Insomnia; Glioma; Sleep

Outcome Measures

Primary Outcomes (9)

• Rate of consent to screening procedures

  Number of participants that consent to screening procedures

  Baseline (Day 1)

• Rate of those eligible enrolling

  Number of participants that are eligible to enroll to the protocol

  Baseline (Day 1)

• Rate of baseline assessment completion

  Number of participants that complete the baseline assessment

  Week 1

• Rate of post-intervention assessment completion

  The number of participants that complete the post-intervention assessment

  Week 6

• Rate of follow-up assessment completion

  The number of participants that complete the follow-up assessment

  Week 18

• Rate of intervention attrition

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

  Week 6

• Acceptability of quantity of assessments

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

  Week 18

• Acceptability of timing of assessments

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

  Week 18

• Acceptability of duration of assessments

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

  Week 18

Study Arms (2)

Telehealth Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy for Insomnia

Enhanced Treatment as Usual

NO INTERVENTION

Interventions

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.

Telehealth Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma; Astrocytoma; Oligodendroglioma; Meningioma; Lymphoma; Sleep Initiation and Maintenance Disorders; Glioma

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ashlee Loughan, Ph.D

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: July 8, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)