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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Experimental | Group intervention; topics include psychoeducation about sleep, sleep restriction, stimulus control, relaxation strategies, and cognitive restructuring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Behavioral | Group presentation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashlee Loughan, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37796017 | Derived | Loughan AR, Lanoye A, Willis KD, Fox A, Ravyts SG, Zukas A, Kim Y. Telehealth group Cognitive-Behavioral Therapy for Insomnia (CBT-I) in primary brain tumor: Primary outcomes from a single-arm phase II feasibility and proof-of-concept trial. Neuro Oncol. 2024 Mar 4;26(3):516-527. doi: 10.1093/neuonc/noad193. |
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Currently there is no plan in place to share data with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2021 | May 13, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Phase IIa Proof-of-Concept Trial
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| 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |