Virginia Commonwealth University
Richmond, Virginia, 23298, United States
NCT Number: NCT04919993
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Richmond, Virginia, 23298, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group presentation
Other names: CBT-I
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.
Time frame: 6 weeks
Percent of sessions attended by consented participants
Time frame: 2 months
Percent of post-session surveys completed by participants immediately after the intervention
Time frame: 5 months
Percent of follow-up surveys completed by participants three months after the intervention
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.
Time frame: 7 months
Total sleep time gathered by the participant from a wrist-worn Actigraph
Time frame: 7 months
Percent of time spent in bed / time asleep gathered by the participant from a wrist-worn Actigraph
Time frame: 7 months
Total sleep time gathered from a participant-reported sleep diary
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.
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.
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?)
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.
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.
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.
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.
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.
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
Time frame: 7 months
Participants' speed of thinking will be assessed by administering the Trail Making Test A, a neuropsychological assessment tool
Time frame: 7 months
Measure executive functioning by administering the Trail Making Test B, a neuropsychological assessment tool
Time frame: 7 months
Participants' language fluency will be measured using the Controlled Oral Word Association Test, a neuropsychological assessment tool
Time frame: 7 months
Participants' ability learn/ memory will be assessed by administering the Hopkins Verbal Learning Test, a neuropsychological assessment tool
Time frame: 7 months
Participants are requested to self-report on their age, gender identity, race/ethnicity, and level of education
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
Virginia Commonwealth University
Other
Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06439420
Astrocytoma, Brain Diseases
Richmond, Virginia, United States
View Trial DetailsNCT02392078
Brain Diseases, Brain Neoplasms
Phoenix, Arizona, United States
View Trial DetailsNCT02389855
Brain Diseases, Brain Neoplasms
New Haven, Connecticut, United States
View Trial DetailsNCT02338037
Brain Diseases, Brain Neoplasms
Duarte, California, United States
View Trial Details