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

Phase 2

Active, not recruiting

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

• Registration Number: NCT06439420
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-03
• Study Start: 2024-07-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of baseline assessment completion	Week 1	Number of participants that complete the baseline assessment
Rate of post-intervention assessment completion	Week 6	The number of participants that complete the post-intervention assessment
Rate of consent to screening procedures	Baseline (Day 1)	Number of participants that consent to screening procedures
Acceptability of quantity of assessments	Week 18	Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best
Rate of intervention attrition	Week 6	The number of participants that do not complete the CBT-I intervention
Rate of those eligible enrolling	Baseline (Day 1)	Number of participants that are eligible to enroll to the protocol
Rate of follow-up assessment completion	Week 18	The number of participants that complete the follow-up assessment
Acceptability of timing of assessments	Week 18	Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best
Acceptability of duration of assessments	Week 18	Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States