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| ID | Type | Description | Link |
|---|---|---|---|
| HM20028336 | Other Identifier | Virginia Commonwealth University |
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This study seeks to investigate an evidence-based, manualized, behavioral health intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I), in individuals with primary brain tumors (PBT) and insomnia. Our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with PBT and insomnia in the behavioral health intervention, CBT-I, and investigate the potential benefits of CBT-I within this at-risk and understudied population. In the long term, the goals are to expand treatment options for neuro-oncology patients and improve their mission readiness and overall wellbeing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth Cognitive Behavioral Therapy for Insomnia | Experimental |
| |
| Enhanced Treatment as Usual | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | CBT-I is a non-pharmacological approach to treating sleep disturbance consisting of educational, behavioral, and cognitive intervention components with evidence-based strategies including sleep efficiency, stimulus control, and sleep hygiene modification. CBT-I includes at least 6 group sessions, each approximately 90 minutes in length, delivered over 6 weeks via telehealth. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of consent to screening procedures | Number of participants that consent to screening procedures | Baseline (Day 1) |
| Rate of those eligible enrolling | Number of participants that are eligible to enroll to the protocol | Baseline (Day 1) |
| Rate of baseline assessment completion | Number of participants that complete the baseline assessment | Week 1 |
| Rate of post-intervention assessment completion | The number of participants that complete the post-intervention assessment | Week 6 |
| Rate of follow-up assessment completion | The number of participants that complete the follow-up assessment | Week 18 |
| Rate of intervention attrition | The number of participants that do not complete the CBT-I intervention | Week 6 |
| Acceptability of quantity of assessments | Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best | Week 18 |
| Acceptability of timing of assessments | Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashlee Loughan, Ph.D | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
There are no plans to share individual participant data.
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|
| Week 18 |
| Acceptability of duration of assessments | Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best | Week 18 |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D008579 | Meningioma |
| D008223 | Lymphoma |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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