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The goal of this study is to evaluate the feasibility and acceptability of delivering cognitive behavioral therapy for insomnia (CBT-I) to gynecologic cancer patients in an internet-based small-group setting.
Secondary objectives:
This is a pilot feasibility study looking at delivering CBT-I to gynecologic cancer patients. This study will be completed via a novel internet based small group platform. Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I online group | Experimental | Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program. At the end of each weekly session, participants will complete a survey reviewing the acceptability of undergoing insomnia treatment in an internet-based small-group setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | 6 sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attendance | Main feasibility metric, recorded as number of sessions successfully attended. Participants would need to attend at least 4 sessions of the CBT-I sessions. Therefore, attendance among all participants must be 67% or greater to be considered feasible. A session must be attended for at least 50% of the time or will be counted as missed. | 6 weeks |
| Acceptability | A three-question survey at the end of each session. Question 1 is yes/no, questions 2 and 3 are write in. At the end of the program, a longer acceptability survey will be conducted. If a participant's response to question 1 indicates acceptability for a given session, that session will be deemed 'acceptable'. If 50% or more of participants rated the session as acceptable, then that session will be rated as acceptable. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia symptoms | Measured by Insomnia Severity Index (ISI) with scale range of 0 to 27, higher numbers indicating more severe insomnia | 24 weeks |
| Changes in quality of life symptoms | Measured by the 7-item Functional Assessment of Cancer Therapy (FACT-G7) Assessment, with likhert scales from 0-4 and higher numbers indicating more severe symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Chen, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| 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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This is a pilot feasibility study looking at delivering small group therapy online.
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| 24 weeks |
| Sleep Quality | Measured by the Pittsburgh Sleep Quality Index (PSQI), score of 0-21 points, higher score indicating more severe difficulty sleeping. | 24 weeks |
| D001523 |
| Mental Disorders |