Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Rate of baseline assessment completion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Rate of baseline assessment completion
Time Frame: Week 1
Number of participants that complete the baseline assessment
Rate of consent to screening procedures
Time Frame: Baseline (Day 1)
Number of participants that consent to screening procedures
Rate of post-intervention assessment completion
Time Frame: Week 6
The number of participants that complete the post-intervention assessment
Acceptability of quantity of assessments
Time Frame: Week 18
Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best
Rate of intervention attrition
Time Frame: Week 6
The number of participants that do not complete the CBT-I intervention
Rate of those eligible enrolling
Time Frame: Baseline (Day 1)
Number of participants that are eligible to enroll to the protocol
Rate of follow-up assessment completion
Time Frame: Week 18
The number of participants that complete the follow-up assessment
Acceptability of timing of assessments
Time Frame: Week 18
Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best
Acceptability of duration of assessments
Time Frame: Week 18
Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best
Secondary Outcomes
No secondary outcomes reported