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CBT for Insomnia in Primary Brain Tumor Patients

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ClinicalTrials.gov Identifier: NCT04919993
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Primary Brain Tumor PBT Behavioral: Cognitive Behavioral Therapy-Insomnia Not Applicable

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 will have an IL-6 added to their regular blood draw.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase IIa Proof-of-Concept Trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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 Name: CBT-I




Primary Outcome Measures :
  1. Feasibility for CBT-I as measured by the rates of participant screening, eligibility, and consent [ Time Frame: 12 months ]
    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.

  2. Attendance at CBT-I sessions [ Time Frame: 6 weeks ]
    Percent of sessions attended by consented participants

  3. Post-session assessment completion [ Time Frame: 2 months ]
    Percent of post-session surveys completed by participants immediately after the intervention

  4. Follow-up assessment completion [ Time Frame: 5 months ]
    Percent of follow-up surveys completed by participants three months after the intervention

  5. 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 [ Time Frame: 7 months ]
    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 :
  1. Objective Sleep [ Time Frame: 7 months ]
    Total sleep time gathered by the participant from a wrist-worn Actigraph

  2. Sleep Efficiency [ Time Frame: 7 months ]
    Percent of time spent in bed / time asleep gathered by the participant from a wrist-worn Actigraph

  3. Subjective Sleep [ Time Frame: 7 months ]
    Total sleep time gathered from a participant-reported sleep diary

  4. Subjective Insomnia [ Time Frame: 7 Months ]
    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.

  5. Subjective Sleep Disturbance [ Time Frame: 7 Months ]
    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.

  6. Napping [ Time Frame: 7 Months ]
    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. Fatigue [ Time Frame: 7 Months ]
    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.

  8. Depression [ Time Frame: 7 Months ]
    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.

  9. Anxiety [ Time Frame: 7 Months ]
    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.

  10. Death Anxiety [ Time Frame: 7 Months ]
    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.

  11. 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. [ Time Frame: 7 Months ]
    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.

  12. Inflammation [ Time Frame: 7 Months ]
    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

  13. Processing Speed [ Time Frame: 7 months ]
    Participants' speed of thinking will be assessed by administering the Trail Making Test A, a neuropsychological assessment tool

  14. Executive Function [ Time Frame: 7 months ]
    Measure executive functioning by administering the Trail Making Test B, a neuropsychological assessment tool

  15. Language Fluency [ Time Frame: 7 months ]
    Participants' language fluency will be measured using the Controlled Oral Word Association Test, a neuropsychological assessment tool

  16. Learning/Memory [ Time Frame: 7 months ]
    Participants' ability learn/ memory will be assessed by administering the Hopkins Verbal Learning Test, a neuropsychological assessment tool

  17. Sociodemographics [ Time Frame: 7 months ]
    Participants are requested to self-report on their age, gender identity, race/ethnicity, and level of education

  18. Primary Brain Tumor Characteristics [ Time Frame: 7 months ]
    Information on participants' tumor diagnosis, treatment history, and medications will be from the participants' medical charts to determine brain tumor characteristics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >/= 18 years old
  • Confirmed primary brain tumor diagnosis via histopathology
  • >/= 2 months 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

Exclusion Criteria:

  • Patients will be excluded from the study if they are not Massey Cancer Center patients
  • Inability to attend weekly group in-person meetings
  • Patients must also meet the inclusion criteria listed above.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919993


Contacts
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Contact: Chanel Livingston 804-628-2822 chanel.livingston@vcuhealth.org

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Kelcie Willis, M.S.       Kelcie.Willis@vcuhealth.org   
Principal Investigator: Ashlee Loughan, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Ashlee Loughan, PhD Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:
Informed Consent Form  [PDF] March 24, 2021

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04919993    
Other Study ID Numbers: MCC-20-16188
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently there is no plan in place to share data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
Cognitive Behavioral Therapy-Insomnia
CBT-I
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Central Nervous System Diseases