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

NCT06439420 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-10-01

No results posted yet for this study

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

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

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.

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Ashlee Loughan, Ph.D · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-08
Primary Completion
2025-09-25
Completion
2025-09-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439420 on ClinicalTrials.gov