Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients
Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
PHASE2 · Virginia Commonwealth University · NCT06439420
This study is testing if Cognitive Behavioral Therapy for Insomnia can help people with brain tumors who have trouble sleeping feel better and improve their overall wellbeing.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06439420 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and acceptability of using Cognitive Behavioral Therapy for Insomnia (CBT-I) in patients with primary brain tumors who also suffer from insomnia. It aims to evaluate recruitment, enrollment, data collection, and retention processes for this behavioral health intervention. The long-term goal is to expand treatment options for neuro-oncology patients and enhance their overall wellbeing and mission readiness.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with primary brain tumors who are experiencing insomnia and meet specific eligibility criteria.
Not a fit: Patients with major communication difficulties or those unable to participate in virtual meetings may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall quality of life for patients with primary brain tumors.
How similar studies have performed: While there is limited research specifically targeting this population, similar approaches using CBT-I have shown promise in other patient groups with insomnia.
Eligibility criteria
Show full 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
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Ashlee Loughan, Ph.D — Virginia Commonwealth University
- Study coordinator: Mary Bridgman
- Email: livenow@vcu.edu
- Phone: (804) 628-6799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Brain Tumor, Glioblastoma, Astrocytoma, Oligodendroglioma, Meningioma, Primary Central Nervous System Lymphoma, Brain Tumor, Insomnia