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The purpose of this study is to determine if CBT-I (cognitive behavioral therapy for insomnia) is a feasible treatment for insomnia in individuals undergoing cancer treatment.
This research study is a single arm feasibility trial in which all eligible participants receive five weekly sessions of CBT-I (cognitive behavioral therapy for insomnia) delivered before or during their cancer treatments. CBT-I is a non-drug behavioral treatment for insomnia and is considered the most effective treatment for insomnia. However, CBT-I is not routinely offered to cancer patients due to unknowns about its feasibility in this population. Data will be obtained at pre- and post-CBT-I and at eight-week follow-up, and will focus on acceptability, implementation, and efficacy in order to assess feasibility. The study will focus on cancer patients who are diagnosed with gastro-intestinal (GI) cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving CBT-I | Experimental | This is a single arm study. All participants will receive CBT-I (cognitive behavioral therapy for insomnia). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I | Behavioral | Eligible participants will receive CBT-I by a licensed clinical psychologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of the score on the Insomnia Severity Index (ISI) | The ISI assesses the severity of insomnia symptoms and subjective daytime impairments. | baseline and at 19th week |
| Measure | Description | Time Frame |
|---|---|---|
| Change of diary-assessed sleep onset latency | Sleep onset latency is the time it takes to fall asleep | baseline and at 19th week |
| Change of diary-assessed wake after sleep onset | wake after sleep onset is the total duration of nighttime awakenings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wai S Chan, PhD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
There is no plan to make individual participant data available to other researchers.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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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| baseline and at 19th week |
| Change of actigraphy-sleep onset latency | Sleep onset latency is the time it takes to fall asleep | baseline and at 19th week |
| Change of actigraphy-assessed wake after sleep onset | wake after sleep onset is the total duration of nighttime awakenings | baseline and at 19th week |
| D001523 |
| Mental Disorders |