Feasibility of Internet Group CBT-I for Gyn Oncology Patients

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06060158
• Other study ID #: 1636910
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: September 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. To compare insomnia symptoms before and after intervention.

2. To evaluate any changes in quality of life symptoms while undergoing the intervention.

3. To evaluate the duration of symptoms improvement after the intervention is complete.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. English-speaking women greater than 18 years old who present to UC Davis Comprehensive Cancer Center for treatment or surveillance of gynecologic cancer

2. Must have access to internet

3. Be able to connect via secure web-based platform

4. Be able to complete online questionnaires

5. Moderate or severe insomnia

6. Have access to a mobile device or computer

Exclusion Criteria:

1. Participants without ability to connect with both audio and visual through secure web-based platform

2. 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

3. Participants with remote history of insomnia, but not currently having symptoms of insomnia

4. Have other reasons for poor sleep

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia
6 sessions

Locations

Country	Name	City	State
United States	University of California, Davis Comprehensive Cancer Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Insomnia symptoms	Measured by Insomnia Severity Index (ISI) with scale range of 0 to 27, higher numbers indicating more severe insomnia	24 weeks
Secondary	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
Secondary	Sleep Quality	Measured by the Pittsburgh Sleep Quality Index (PSQI), score of 0-21 points, higher score indicating more severe difficulty sleeping.	24 weeks