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

September 30, 2025 updated by: Virginia Commonwealth University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telehealth Cognitive Behavioral Therapy for Insomnia
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.
No Intervention: Enhanced Treatment as Usual

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Ashlee Loughan, Ph.D, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2024

Primary Completion (Actual)

September 25, 2025

Study Completion (Actual)

September 25, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23-20323
  • HM20028336 (Other Identifier: Virginia Commonwealth University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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