Clinical trial NCT04919993: CBT for Insomnia in Primary Brain Tumor Patients
Official title: Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Brain Tumor
PBT
Keywords: Cognitive Behavioral Therapy-Insomnia
CBT-I
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase IIa Proof-of-Concept Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The present study design is a pilot within-subjects pre-/post-evaluation of feasibility, acceptability, and preliminary efficacy of the Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention for primary brain tumor patients. In this study, participants will be asked to do the following things:

* Meet with a trained interventionist six times (biweekly) for group CBT-I sessions via Zoom, lasting 90 minutes each. Participants will be asked to only use first names and will complete weekly sleep diaries as part of the intervention.
* Complete \~20-minute online surveys before the program, immediately after the program (6 weeks), and at follow-up (3 months). Questions will ask about subjective sleep, fatigue, mood, and quality of life. The follow-up time point will also ask about the patient's satisfaction with the CBT-I program.
* Complete a brief (15 minute) cognitive evaluation before and immediately following the program.
* Wear a wrist-worn actigraphy monitor one week prior to the 6-week CBT-I intervention and one week following completion of the intervention.
* Patients currently receiving regular blood draws as part of their care at Massey Cancer Center will have an IL-6 added to their regular blood draw. THose who are not receiving regular blood draws as part of their standard of care OR those who are not patients at Massey Cancer Center will forego this part of the intervention.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility for CBT-I as measured by the rates of participant screening, eligibility, and consent
timeFrame: 12 months
measure: Attendance at CBT-I sessions
timeFrame: 6 weeks
measure: Post-session assessment completion
timeFrame: 2 months
measure: Follow-up assessment completion
timeFrame: 5 months
measure: Program Satisfaction as measured by participant responses to researcher-developed questions (e.g., How satisfied were you with the program overall?) measured on a Likert scale
timeFrame: 7 months
Secondary outcomes:
measure: Objective Sleep
timeFrame: 7 months
measure: Sleep Efficiency
timeFrame: 7 months
measure: Subjective Sleep
timeFrame: 7 months
measure: Subjective Insomnia
timeFrame: 7 Months
measure: Subjective Sleep Disturbance
timeFrame: 7 Months
measure: Napping
timeFrame: 7 Months
measure: Fatigue
timeFrame: 7 Months
measure: Depression
timeFrame: 7 Months
measure: Anxiety
timeFrame: 7 Months
measure: Death Anxiety
timeFrame: 7 Months
measure: Subjective Quality of Life as measured by participants' responses on the European Organization Research and Treatment of Cancer - Quality of Life - Cancer 30 (EORTC-QoL-C30) form.
timeFrame: 7 Months
measure: Inflammation
timeFrame: 7 Months
measure: Processing Speed
timeFrame: 7 months
measure: Executive Function
timeFrame: 7 months
measure: Language Fluency
timeFrame: 7 months
measure: Learning/Memory
timeFrame: 7 months
measure: Sociodemographics
timeFrame: 7 months
measure: Primary Brain Tumor Characteristics
timeFrame: 7 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ashlee Loughan, PhD
role: PRINCIPAL_INVESTIGATOR
References: