CBT for Insomnia in Primary Brain Tumor Patients
Primary Purpose
Primary Brain Tumor, PBT
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy-Insomnia
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Brain Tumor focused on measuring Cognitive Behavioral Therapy-Insomnia, CBT-I
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.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Arm Description
Group intervention; topics include psychoeducation about sleep, sleep restriction, stimulus control, relaxation strategies, and cognitive restructuring.
Outcomes
Primary Outcome Measures
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.
Attendance at CBT-I sessions
Percent of sessions attended by consented participants
Post-session assessment completion
Percent of post-session surveys completed by participants immediately after the intervention
Follow-up assessment completion
Percent of follow-up surveys completed by participants three months after the intervention
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.
Secondary Outcome Measures
Objective Sleep
Total sleep time gathered by the participant from a wrist-worn Actigraph
Sleep Efficiency
Percent of time spent in bed / time asleep gathered by the participant from a wrist-worn Actigraph
Subjective Sleep
Total sleep time gathered from a participant-reported sleep diary
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.
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.
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?)
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.
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.
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.
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.
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.
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
Processing Speed
Participants' speed of thinking will be assessed by administering the Trail Making Test A, a neuropsychological assessment tool
Executive Function
Measure executive functioning by administering the Trail Making Test B, a neuropsychological assessment tool
Language Fluency
Participants' language fluency will be measured using the Controlled Oral Word Association Test, a neuropsychological assessment tool
Learning/Memory
Participants' ability learn/ memory will be assessed by administering the Hopkins Verbal Learning Test, a neuropsychological assessment tool
Sociodemographics
Participants are requested to self-report on their age, gender identity, race/ethnicity, and level of education
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
Full Information
NCT ID
NCT04919993
First Posted
May 24, 2021
Last Updated
January 12, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT04919993
Brief Title
CBT for Insomnia in Primary Brain Tumor Patients
Official Title
Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Brain Tumor, PBT
Keywords
Cognitive Behavioral Therapy-Insomnia, CBT-I
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Phase IIa Proof-of-Concept Trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Arm Type
Experimental
Arm Description
Group intervention; topics include psychoeducation about sleep, sleep restriction, stimulus control, relaxation strategies, and cognitive restructuring.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy-Insomnia
Other Intervention Name(s)
CBT-I
Intervention Description
Group presentation
Primary Outcome Measure Information:
Title
Feasibility for CBT-I as measured by the rates of participant screening, eligibility, and consent
Description
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.
Time Frame
12 months
Title
Attendance at CBT-I sessions
Description
Percent of sessions attended by consented participants
Time Frame
6 weeks
Title
Post-session assessment completion
Description
Percent of post-session surveys completed by participants immediately after the intervention
Time Frame
2 months
Title
Follow-up assessment completion
Description
Percent of follow-up surveys completed by participants three months after the intervention
Time Frame
5 months
Title
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
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Objective Sleep
Description
Total sleep time gathered by the participant from a wrist-worn Actigraph
Time Frame
7 months
Title
Sleep Efficiency
Description
Percent of time spent in bed / time asleep gathered by the participant from a wrist-worn Actigraph
Time Frame
7 months
Title
Subjective Sleep
Description
Total sleep time gathered from a participant-reported sleep diary
Time Frame
7 months
Title
Subjective Insomnia
Description
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.
Time Frame
7 Months
Title
Subjective Sleep Disturbance
Description
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.
Time Frame
7 Months
Title
Napping
Description
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?)
Time Frame
7 Months
Title
Fatigue
Description
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.
Time Frame
7 Months
Title
Depression
Description
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.
Time Frame
7 Months
Title
Anxiety
Description
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.
Time Frame
7 Months
Title
Death Anxiety
Description
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.
Time Frame
7 Months
Title
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.
Description
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.
Time Frame
7 Months
Title
Inflammation
Description
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
Time Frame
7 Months
Title
Processing Speed
Description
Participants' speed of thinking will be assessed by administering the Trail Making Test A, a neuropsychological assessment tool
Time Frame
7 months
Title
Executive Function
Description
Measure executive functioning by administering the Trail Making Test B, a neuropsychological assessment tool
Time Frame
7 months
Title
Language Fluency
Description
Participants' language fluency will be measured using the Controlled Oral Word Association Test, a neuropsychological assessment tool
Time Frame
7 months
Title
Learning/Memory
Description
Participants' ability learn/ memory will be assessed by administering the Hopkins Verbal Learning Test, a neuropsychological assessment tool
Time Frame
7 months
Title
Sociodemographics
Description
Participants are requested to self-report on their age, gender identity, race/ethnicity, and level of education
Time Frame
7 months
Title
Primary Brain Tumor Characteristics
Description
Information on participants' tumor diagnosis, treatment history, and medications will be from the participants' medical charts to determine brain tumor characteristics
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashlee Loughan, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently there is no plan in place to share data with other researchers.
Learn more about this trial
CBT for Insomnia in Primary Brain Tumor Patients
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