CBT for Insomnia in Primary Brain Tumor Patients

Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients

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.

Study Overview

• Status: Completed
• Conditions: Primary Brain Tumor; PBT
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy-Insomnia

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy for Insomnia (CBT-I); Group intervention; topics include psychoeducation about sleep, sleep restriction, stimulus control, relaxation strategies, and cognitive restructuring.	Behavioral: Cognitive Behavioral Therapy-Insomnia; Group presentation; Other Names: CBT-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility for CBT-I as measured by the rates of participant screening, eligibility, and consent	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.	12 months
Attendance at CBT-I sessions	Percent of sessions attended by consented participants	6 weeks
Post-session assessment completion	Percent of post-session surveys completed by participants immediately after the intervention	2 months
Follow-up assessment completion	Percent of follow-up surveys completed by participants three months after the intervention	5 months
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	Program satisfaction questions are measured on a 10-point Likert scale with 1 being not at all satisfied and 10 being very much satisfied. Higher scores indicate greater program satisfaction.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Sleep	Total sleep time gathered by the participant from a wrist-worn Actigraph	7 months
Sleep Efficiency	Percent of time spent in bed / time asleep gathered by the participant from a wrist-worn Actigraph	7 months
Subjective Sleep	Total sleep time gathered from a participant-reported sleep diary	7 months
Subjective Insomnia	Determine the degree of participant insomnia using the Insomnia Severity Index, a brief self-report questionnaire measured on a 5-point Likert scale (0 = None, 4 = Very Severe). Higher scores indicate greater subjective insomnia.	7 Months
Subjective Sleep Disturbance	Determine the degree of participant sleep disturbance using the Pittsburgh Sleep Quality Index, a brief self-report questionnaire. Higher scores indicate greater global sleep disturbance.	7 Months
Napping	Request that participants self report how many hours a day they nap on average using one self-report question (During the past month, how many hours did you nap during a typical day?)	7 Months
Fatigue	Determine participants' level of fatigue using the Brief Fatigue Inventory, a self-report questionnaire measured on a 11-point Likert scale (0 = No Fatigue/Does Not Interfere; 10 = As Bad as You Can Imagine/Completely Interferes). Higher scores indicate greater symptoms of fatigue.	7 Months
Depression	Determine the extent of depressive symptoms using the Patient Health Questionnaire-9, a brief-self report questionnaire measured on a 4-point Likert scale (0 = Not at All; 3 = Nearly Everyday) Higher scores indicate greater symptoms of depression.	7 Months
Anxiety	Determine the extent of anxiety symptoms using the Generalized Anxiety Disorder-7, a self-report questionnaire measured on a 4-point Likert scale (0 = Not at All; 3 = Nearly Everyday). Higher scores indicate greater symptoms of anxiety.	7 Months
Death Anxiety	Determine the level of participant's death anxiety using the Death and Dying Distress Scale, a self-report questionnaire measured on a 6-point Likert scale (0 = Not Distress; 5 = Extreme Distress). Higher scores indicate greater symptoms of death anxiety.	7 Months
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.	Determine participants' level of quality of life using the EORTC-QoL-C30, a self-report questionnaire measured on a 4-point Likert scale (1 = Not at All; 4 = Very Much). Higher scores indicate lower overall quality of life.	7 Months
Inflammation	Determine the level of inflammation as measured by the amount of Cytokine Interleukin-6 (IL-6) in the participant's blood; only participants receiving regular blood draws as part of their routine will have this data	7 Months
Processing Speed	Participants' speed of thinking will be assessed by administering the Trail Making Test A, a neuropsychological assessment tool	7 months
Executive Function	Measure executive functioning by administering the Trail Making Test B, a neuropsychological assessment tool	7 months
Language Fluency	Participants' language fluency will be measured using the Controlled Oral Word Association Test, a neuropsychological assessment tool	7 months
Learning/Memory	Participants' ability learn/ memory will be assessed by administering the Hopkins Verbal Learning Test, a neuropsychological assessment tool	7 months
Sociodemographics	Participants are requested to self-report on their age, gender identity, race/ethnicity, and level of education	7 months
Primary Brain Tumor Characteristics	Information on participants' tumor diagnosis, treatment history, and medications will be from the participants' medical charts to determine brain tumor characteristics	7 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: CBT-I; Cognitive Behavioral Therapy-Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Sleep Initiation and Maintenance Disorders; Brain Neoplasms
• Other Study ID Numbers: MCC-20-16188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently there is no plan in place to share data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No