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Feasibility of Internet Group CBT-I for Gyn Oncology Patients

University of California (UC) Davis logo

University of California (UC) Davis

Status

Completed

Conditions

Insomnia

Treatments

Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type

Interventional

Funder types

Other

Identifiers

NCT06060158
1636910

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

CBT-I online group
Experimental group
Description:
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:
Behavioral: Cognitive Behavioral Therapy for Insomnia

Trial contacts and locations

1

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Central trial contact

UC Davis Comprehensive Cancer Center; Katie Van Deventer, MD

Data sourced from clinicaltrials.gov

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