Astrocytoma, Glioblastoma, Meningioma, Oligodendroglioma, Primary Brain Tumor, Primary Central Nervous System (CNS) Lymphoma
Conditions
Keywords
Brain Tumor, Insomnia, Glioma, Sleep
Brief summary
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of consent to screening procedures | Baseline (Day 1) | Number of participants that consent to screening procedures |
| Rate of those eligible enrolling | Baseline (Day 1) | Number of participants that are eligible to enroll to the protocol |
| Rate of baseline assessment completion | Week 1 | Number of participants that complete the baseline assessment |
| Rate of post-intervention assessment completion | Week 6 | The number of participants that complete the post-intervention assessment |
| Rate of follow-up assessment completion | Week 18 | The number of participants that complete the follow-up assessment |
| Rate of intervention attrition | Week 6 | The number of participants that do not complete the CBT-I intervention |
| Acceptability of quantity of assessments | Week 18 | Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best |
| Acceptability of timing of assessments | Week 18 | Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best |
| Acceptability of duration of assessments | Week 18 | Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best |
Countries
United States
Outcome results
None listed