CBT for Insomnia in Primary Brain Tumor Patients

Primary Brain Tumor Clinical Trial

Official title: Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients

Status Completed

Clinical Trial Summary

The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Cognitive Behavior Therapy for Insomnia (CBT-I) in primary brain tumor patients. Researchers hope to better understand the feasibility and acceptability of this intervention in neuro-oncology, as well as the preliminary potential benefits of this intervention on brain tumor patients' sleep, fatigue, mood, quality of life, and chronic inflammation. This may lead to improvements in treating insomnia in primary brain tumor patients.

Clinical Trial Description

The present study design is a pilot within-subjects pre-/post-evaluation of feasibility, acceptability, and preliminary efficacy of the Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention for primary brain tumor patients. In this study, participants will be asked to do the following things:

• Meet with a trained interventionist six times (biweekly) for group CBT-I sessions via Zoom, lasting 90 minutes each. Participants will be asked to only use first names and will complete weekly sleep diaries as part of the intervention.

• Complete ~20-minute online surveys before the program, immediately after the program (6 weeks), and at follow-up (3 months). Questions will ask about subjective sleep, fatigue, mood, and quality of life. The follow-up time point will also ask about the patient's satisfaction with the CBT-I program.

• Complete a brief (15 minute) cognitive evaluation before and immediately following the program.

• Wear a wrist-worn actigraphy monitor one week prior to the 6-week CBT-I intervention and one week following completion of the intervention.

• Patients currently receiving regular blood draws as part of their care at Massey Cancer Center will have an IL-6 added to their regular blood draw. THose who are not receiving regular blood draws as part of their standard of care OR those who are not patients at Massey Cancer Center will forego this part of the intervention. ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Primary Brain Tumor
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT04919993
• Study type: Interventional
• Source: Virginia Commonwealth University
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Completion date: August 15, 2022