CBT for Insomnia in Primary Brain Tumor Patients

Primary Brain Tumor Clinical Trial

Official title:

Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919993
• Other study ID #: MCC-20-16188
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: January 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Primary Brain Tumor
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy-Insomnia
Group presentation

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Attendance at CBT-I sessions	Percent of sessions attended by consented participants	6 weeks
Primary	Post-session assessment completion	Percent of post-session surveys completed by participants immediately after the intervention	2 months
Primary	Follow-up assessment completion	Percent of follow-up surveys completed by participants three months after the intervention	5 months
Primary	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	Objective Sleep	Total sleep time gathered by the participant from a wrist-worn Actigraph	7 months
Secondary	Sleep Efficiency	Percent of time spent in bed / time asleep gathered by the participant from a wrist-worn Actigraph	7 months
Secondary	Subjective Sleep	Total sleep time gathered from a participant-reported sleep diary	7 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Processing Speed	Participants' speed of thinking will be assessed by administering the Trail Making Test A, a neuropsychological assessment tool	7 months
Secondary	Executive Function	Measure executive functioning by administering the Trail Making Test B, a neuropsychological assessment tool	7 months
Secondary	Language Fluency	Participants' language fluency will be measured using the Controlled Oral Word Association Test, a neuropsychological assessment tool	7 months
Secondary	Learning/Memory	Participants' ability learn/ memory will be assessed by administering the Hopkins Verbal Learning Test, a neuropsychological assessment tool	7 months
Secondary	Sociodemographics	Participants are requested to self-report on their age, gender identity, race/ethnicity, and level of education	7 months
Secondary	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