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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
Virginia Commonwealth University
Richmond, Virginia, United States
Rate of consent to screening procedures
Number of participants that consent to screening procedures
Time frame: Baseline (Day 1)
Rate of those eligible enrolling
Number of participants that are eligible to enroll to the protocol
Time frame: Baseline (Day 1)
Rate of baseline assessment completion
Number of participants that complete the baseline assessment
Time frame: Week 1
Rate of post-intervention assessment completion
The number of participants that complete the post-intervention assessment
Time frame: Week 6
Rate of follow-up assessment completion
The number of participants that complete the follow-up assessment
Time frame: Week 18
Rate of intervention attrition
The number of participants that do not complete the CBT-I intervention
Time frame: Week 6
Acceptability of quantity of assessments
Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best
Time frame: Week 18
Acceptability of timing of assessments
Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best
Time frame: Week 18
Acceptability of duration of assessments
Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best
Time frame: Week 18
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