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

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial, called "CBT-I in Primary Brain Tumor Patients," is looking at how a specific type of therapy called Cognitive Behavioral Therapy for Insomnia (CBT-I) can help patients with primary brain tumors who are having trouble sleeping. The study aims to see if it’s possible to enroll and keep participants in this program and to understand how this therapy might improve their sleep and overall wellbeing. The researchers want to find out if CBT-I can be a helpful treatment option for people with brain tumors, which can often be overlooked when it comes to addressing sleep issues.

To participate in this trial, individuals must be between the ages of 65 and 74 and have a diagnosed primary brain tumor. They should be at least two weeks post-surgery (if applicable) and one month post-radiation therapy (if applicable). Participants need to be comfortable using English and must have a reliable internet connection for weekly virtual group meetings. It’s important that they do not have major cognitive issues that would affect their ability to participate. If you or someone you know meets these criteria and is interested in improving sleep, this trial might be a great opportunity!

Gender

ALL

Eligibility criteria

• 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

Trial Officials