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Completed

NCT Number: NCT06060158

Feasibility of Internet Group CBT-I for Gyn Oncology Patients

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

6 sessions

Primary outcomes

  1. Attendance

    Time frame: 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.

  2. Acceptability

    Time frame: 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 outcomes

  1. Insomnia symptoms

    Time frame: 24 weeks

    Measured by Insomnia Severity Index (ISI) with scale range of 0 to 27, higher numbers indicating more severe insomnia

  2. Changes in quality of life symptoms

    Time frame: 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

  3. Sleep Quality

    Time frame: 24 weeks

    Measured by the Pittsburgh Sleep Quality Index (PSQI), score of 0-21 points, higher score indicating more severe difficulty sleeping.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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