A Computerized CBTi for Insomnia in Epilepsy

NCT03632889 | Completed

• 1 other identifier: 18-242
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Epilepsy; Insomnia

Outcome Measures

Primary Outcomes (1)

• Primary Aim - To compare change in Insomnia Severity Index (ISI) score from baseline to week 8 between Go! to sleep (GTS) and control in people with epilepsy and moderate-to-severe insomnia.

  The number of participants with change in Insomnia Severity Index (ISI) score, total range score of 0-28, from baseline to week 8 in people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program compare to the number of participants with change in Insomnia Severity Index (ISI) score from baseline to week 8 in people with epilepsy (PWE) and moderate-to-severe insomnia without Go! To sleep (GTS) program

  baseline to 8 weeks

Secondary Outcomes (16)

• Secondary Aim 1 - To compare change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.

  Baseline to 8 weeks

• Secondary Aim 2 - To compare change in fatigue symptom on the Fatigue Severity Scale (FSS) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.

  Baseline to 8 weeks

• Secondary Aim 3 - To compare change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.

  Baseline to 8 weeks

• Secondary Aim 4 - To compare change in self-reported daily total sleep time (TST) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.

  Baseline to 8 weeks

• Secondary Aim 5 - To compare change in depression symptom on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.

  Baseline to 8 weeks

Study Arms (2)

Control Arm

NO INTERVENTION

Subjects randomized to the control group will receive a sleep hygiene handout .

Computerized Group

OTHER

Subjects randomized to GoToSleep program will receive a sleep hygiene handout and a unique code for home access to the GoToSleep program.

Behavioral: GoToSleep Program

Interventions

GoToSleep Program BEHAVIORAL

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.

Computerized Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Baseline ISI score ≥15
• Stable antiepileptic drug (AED) therapy for \>30 days prior to enrollment without planned medication change, surgery or in-patient testing in the coming 90 days
• Able to quantify seizures
• Daily access to computer and internet
• Sufficient computer skills to engage in the on-line program
• Able to speak, read and understand English

You may not qualify if:

• Poorly quantified epileptic seizures, psychogenic non-epileptic seizures or other types of spells of undetermined etiology
• Cognitive impairment judged to be significant enough so as to impair one's ability to adhere to study procedures and sleep recommendations
• Major depression with suicidal ideations or presence of active co-morbid conditions that may affect study participation/completion
• Co-morbid sleep disorders that could be contributing to insomnia symptoms such as sleep apnea, restless legs syndrome (RLS) and circadian rhythm disorders
• Use of sedative-hypnotics, benzodiazepines, psychotropics, wake promoting agents and stimulants will be permitted provided the subject has been on a stable dose for at least 1 month.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Epilepsy; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Nancy Foldvary-Schaefer, DO

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 16, 2018
• Study Start: July 24, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

US (1)