Feasibility of Internet Group CBT-I for Gyn Oncology Patients

Sponsor

University of California, Davis (Other)

Overall Status

Recruiting

CT.gov ID

NCT06060158

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: Cognitive Behavioral Therapy for Insomnia	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a pilot feasibility study looking at delivering small group therapy online.This is a pilot feasibility study looking at delivering small group therapy online.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBT-I online group 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 6 sessions

Arm

Intervention/Treatment

Experimental: CBT-I online group

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

6 sessions

Outcome Measures

Primary Outcome Measures

Attendance [6 weeks]
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.
Acceptability [24 weeks]
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.

Secondary Outcome Measures

Insomnia symptoms [24 weeks]
Measured by Insomnia Severity Index (ISI) with scale range of 0 to 27, higher numbers indicating more severe insomnia
Changes in quality of life symptoms [24 weeks]
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
Sleep Quality [24 weeks]
Measured by the Pittsburgh Sleep Quality Index (PSQI), score of 0-21 points, higher score indicating more severe difficulty sleeping.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Davis Comprehensive Cancer Center	Sacramento	California	United States	95817

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator: Hui Chen, MD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT06060158

Other Study ID Numbers:

1636910

First Posted:

Sep 29, 2023

Last Update Posted:

Sep 29, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Sep 29, 2023