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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06439420
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Virginia Commonwealth University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ashlee Loughan, Ph.D
Principal Investigator Affiliation Virginia Commonwealth University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Primary Brain Tumor, Glioblastoma, Astrocytoma, Oligodendroglioma, Meningioma, Primary Central Nervous System (CNS) Lymphoma
Arms & Interventions

Arms

Experimental: Telehealth Cognitive Behavioral Therapy for Insomnia

No Intervention: Enhanced Treatment as Usual

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Virginia Commonwealth University, Richmond, Virginia

Status

Address

Virginia Commonwealth University

Richmond, Virginia, 23298