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Behavioral Intervention

Online Group CBT-I for Insomnia in Cancer Patients

N/A

Recruiting

Led By Hui Chen, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate or severe insomnia

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial tests if online therapy can help gynecologic cancer patients reduce their insomnia and improve their quality of life.

Who is the study for?

This trial is for English-speaking women over 18 with moderate or severe insomnia who are being treated or monitored for gynecologic cancer at UC Davis Comprehensive Cancer Center. They must have internet access, be able to use a secure web platform and complete online questionnaires using a mobile device or computer.Check my eligibility

What is being tested?

The study tests the effectiveness of delivering cognitive behavioral therapy for insomnia (CBT-I) via the internet in small groups to these patients. It will assess changes in their sleep quality and overall life quality before and after treatment, as well as how long improvements last.See study design

What are the potential side effects?

Since CBT-I is a non-medical therapy involving no drugs, it typically doesn't have physical side effects. However, participants may experience temporary increases in anxiety or stress due to discussing their thoughts and behaviors related to sleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have trouble sleeping most nights.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Attendance

Secondary outcome measures

Changes in quality of life symptoms

Insomnia symptoms

Sleep Quality

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624

Hematoma R side abdomen

Severe vaginal bleeding and pain

Chest pain in a patient with CAD

Asthma

100%

80%

60%

40%

20%

Study treatment Arm

Antidepressant + Desensitization

Antidepressant + Cognitive Behavioral

Trial Design

1Treatment groups

Experimental Treatment

Group I: CBT-I online groupExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy for Insomnia

2013

Completed Phase 3

~1800

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,507 Total Patients Enrolled

Hui Chen, MDPrincipal InvestigatorUniversity of California, Davis

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do any vacancies remain for potential participants in this clinical trial?

"This clinical trial is currently enlisting patients, as reported on clinicaltrials.gov. The study was made available to the public on November 1st of 2023 and has been recently updated on September 23rd of the same year."

Answered by AI

What is the recruited sample size for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this trial is currently recruiting participants with the initial posting on November 1st 2023 and the most recent update on September 23rd 2023. This examination involves 12 individuals from one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Internet Group CBT-I for Gyn Oncology Patients

2023. "Feasibility of Internet Group CBT-I for Gyn Oncology Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06060158.