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

Glioblastoma Clinical Trial

— CBT-I in PBT  

Official title:

Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439420
• Other study ID #: MCC-23-20323
• Secondary ID: HM20028336
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Mary Bridgman
• Phone: (804) 628-6799
• Email: livenow[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astrocytoma
• Brain Neoplasms
• Glioblastoma
• Meningioma
• Oligodendroglioma
• Primary Brain Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

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