InsomniaNCT06060158
Feasibility of Internet Group CBT-I for Gyn Oncology Patients
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: Feasibility of Internet-Delivered Group Cognitive Behavioral Therapy for Insomnia in Gynecologic 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:
- 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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
6 sessions
| Study group | Role | What they receive |
|---|---|---|
| CBT-I online group | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 24 weeks
Secondary outcomes (3)
Insomnia symptoms
Measured by Insomnia Severity Index (ISI) with scale range of 0 to 27, higher numbers indicating more severe insomnia
Measured: 24 weeks
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
Measured: 24 weeks
Sleep Quality
Measured by the Pittsburgh Sleep Quality Index (PSQI), score of 0-21 points, higher score indicating more severe difficulty sleeping.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start26 Feb 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot feasibility study looking at delivering small group therapy online.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Chen, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060158
- Sponsor's protocol ID
- 1636910
- Status last verified
- Jan 2025
- First submitted
- 29 Jun 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Internet-Delivered Group Cognitive Behavioral Therapy for Insomnia in Gynecologic Oncology Patients
- ClinicalTrials.gov ID
- NCT06060158
- Acronym / sponsor ID
- 1636910
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot feasibility study looking at delivering small group therapy online.
| Arm | Type | Receives |
|---|---|---|
| CBT-I online group | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaTwelve 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia6 sessions | Behavioural | CBT-I online group |
Primary outcome
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.
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.
3 secondary outcomes
Insomnia symptoms
Time frame: 24 weeks
Changes in quality of life symptoms
Time frame: 24 weeks
Sleep Quality
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Chen, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.