Clinical trial · Interventional
CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Oligodendroglioma | Oligodendroglioma | CURATED_BROADER | 0.80 |
| Primary Brain Tumor | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
| Primary Central Nervous System (CNS) Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Telehealth Cognitive Behavioral Therapy for Insomnia
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- type
- NO_INTERVENTION
- label
- Enhanced Treatment as Usual
Primary outcomes (9)
- measure
- Rate of consent to screening procedures
- timeFrame
- Baseline (Day 1)
- description
- Number of participants that consent to screening procedures
- measure
- Rate of those eligible enrolling
- timeFrame
- Baseline (Day 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available