Feasibility of Internet Group CBT-I for Gyn Oncology Patients

Study Overview
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Brief Summary
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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: To compare insomnia symptoms before and after intervention. To evaluate any changes in quality of life symptoms while undergoing the intervention. To evaluate the duration of symptoms improvement after the intervention is complete.

Detailed Description
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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.

Official Title
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Feasibility of Internet-Delivered Group Cognitive Behavioral Therapy for Insomnia in Gynecologic Oncology Patients

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking women greater than 18 years old who present to UC Davis Comprehensive Cancer Center for treatment or surveillance of gynecologic cancer Must have access to internet Be able to connect via secure web-based platform Be able to complete online questionnaires Moderate or severe insomnia Have access to a mobile device or computer Exclusion Criteria: Participants without ability to connect with both audio and visual through secure web-based platform Participant is currently taking sleep medication prescribed by their provider for sleep disturbance or insomnia - Patients taking over the counter medications or supplements are eligible Participants with remote history of insomnia, but not currently having symptoms of insomnia Have other reasons for poor sleep

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a pilot feasibility study looking at delivering small group therapy online.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-I online group<br>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. | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* 6 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |