Feasibility of Internet Group CBT-I for Gyn Oncology Patients

NCT ID: NCT06060158

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2024-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

6 sessions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Behavioral Therapy for Insomnia

6 sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hui Chen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1636910

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive-Behavior Therapy for Insomnia
NCT00869934 COMPLETED PHASE4