Clinical trial · Interventional
CBT for Insomnia in Primary Brain Tumor Patients
Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients
- 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)
The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Cognitive Behavior Therapy for Insomnia (CBT-I) in primary brain tumor patients. Researchers hope to better understand the feasibility and acceptability of this intervention in neuro-oncology, as well as the preliminary potential benefits of this intervention on brain tumor patients' sleep, fatigue, mood, quality of life, and chronic inflammation. This may lead to improvements in treating insomnia in primary brain tumor patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PBT | — | UNRESOLVED | — |
| Primary Brain Tumor | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- description
- Group intervention; topics include psychoeducation about sleep, sleep restriction, stimulus control, relaxation strategies, and cognitive restructuring.
- interventionNames
- Behavioral: Cognitive Behavioral Therapy-Insomnia
Primary outcomes (5)
- measure
- Feasibility for CBT-I as measured by the rates of participant screening, eligibility, and consent
- timeFrame
- 12 months
- description
- Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.
- measure
- Attendance at CBT-I sessions
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>/= 18 years old * Confirmed primary brain tumor diagnosis * \>/= 1 month removed from radiation therapy (if applicable) * Able to readily read and understand English * Meeting DSM-V diagnostic criteria for insomnia as measured by the Structured Clinical Interview for DSM-5 * Sleep Disorders (SCISD) insomnia subsection * Cognitively intact as measured by a score \>20 on the Telephone Interview for Cognitive Status (TICS) * Have a stable internet connection and video-capable device for Zoom sessions Exclusion Criteria: * Inability to attend weekly group in-person meetings * Patients must also meet the inclusion criteria listed above.
References
Publications (1)
- DERIVEDLoughan AR, Lanoye A, Willis KD, Fox A, Ravyts SG, Zukas A, Kim Y. Telehealth group Cognitive-Behavioral Therapy for Insomnia (CBT-I) in primary brain tumor: Primary outcomes from a single-arm phase II feasibility and proof-of-concept trial. Neuro Oncol. 2024 Mar 4;26(3):516-527. doi: 10.1093/neuonc/noad193. PMID 37796017