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A Computerized CBTi for Insomnia in Epilepsy

NCT03632889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-02-10

No results posted yet for this study

Summary

This is a pilot study.

The Investigators propose a pilot randomized, parallel-group, controlled trial comparing the GoToSleep program (GTS) and controls on change in Insomnia Severity Index (ISI) from baseline to week 8 in adults with epilepsy and moderate-to-severe insomnia.

Adults with epilepsy and moderate-to-severe insomnia symptoms (ISI ≥15) 17 will be identified using data collected as part of routine clinical care in the adult epilepsy clinic.

All subjects will be provided a consent form describing the study and provided sufficient information to make an informed decision. After a screening visit, subjects meeting study criteria will be randomized to the computerized cognitive behavioral therapy for insomnia (CCBT-i) using the GoTosleep (GTS) or the control group. Both groups will receive a sleep hygiene handout that is standard of care in the treatment of insomnia. All subjects will be contacted by phone every 2 weeks during the intervention to address questions related to sleep hygiene instructions and use of the CCBT-i in the GoTosleep (GTS) group. All subjects will complete a series of sleep related patient reported outcomes including the ISI at baseline 8 weeks post randomization and maintain a diary recording of seizures and sleep periods. Those randomized to CCBT-i will complete a questionnaire at week 8 assessing barriers to CCBT-i.

Subjects randomized to the control group will be offered access to the GoTosleep (GTS) at no charge at the end of the study (week 8).

Conditions

Interventions

BEHAVIORAL

GoToSleep Program

For the control group only the sleep hygiene handout will be given in this arm. For the computerized group a sleep hygiene handout along with assess to the GoToSleep online program.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Nancy Foldvary-Schaefer, DO · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03632889 on ClinicalTrials.gov