A Computerized CBTi for Insomnia in Epilepsy

NCT ID: NCT03632889

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2022-12-31

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).

Detailed Description

Growing interest in the relationship between epilepsy and sleep has resulted in a number of investigations demonstrating the high prevalence of sleep disturbances and disorders in people with epilepsy (PWE). PWE frequently report daytime sleepiness, insomnia, and other sleep problems.

Insomnia is among the most common sleep complaint in PWE. The prevalence of moderate-to-severe insomnia using the ISI ranges from 15% to 51%. A recent case-control study found an association between insomnia symptom severity and poorer seizure control. Difficulty maintaining sleep is the most common insomnia presentation followed by difficulty initiating sleep. Both patterns are accompanied by a decrease in total sleep time and an increase in the number of awakenings, arousals and wake time after sleep onset, leading to a state of relative sleep deprivation. Like epilepsy, insomnia disorders are commonly associated with co-morbid depression in the general population, confirmed in a cohort of adults with epilepsy from our own epilepsy center. In turn, treatment of depression has been shown to improve insomnia in the general population. Further, improved seizure control has been observed following treatment of other comorbid sleep disorders such as obstructive sleep apnea and poor sleep hygiene. Innovative sleep treatments for PWE are needed.

To date, there are no studies exploring sleep and seizure outcomes with treatment of insomnia in PWE. Cognitive Behavioral Therapy for Insomnia(CBT-i) is generally the preferred initial treatment for most cases of primary insomnia. CBT-i examines and promotes modifications in thoughts and behaviors that perpetuate insomnia. The validity of CBT-i has been well established and the American College of Physicians has acknowledged CBT-i as the first-line therapy for insomnia with treatment effects that outlast those of sedative-hypnotic medications. Despite its established efficacy, CBT-i is not widely accessible due to the lack of trained clinicians, stigmatization in receiving psychological services, geographical remoteness to trained providers and cost. Treatment typically involves a series of up to 10 visits at weekly or biweekly intervals.

In recent years, CCBT-i programs have been developed that offer web-based treatment. One such program is GoTo sleep (GTS), developed and validated by investigators at the Cleveland Clinic. GTS constitutes 6 weeks of therapy based on the principles and methods of CBT-i presented as a series of daily lessons, learnable skills, and personalized recommendations supported by graphics, animations, audio and video. The program includes the basic elements of CBT-i including sleep hygiene, sleep restriction, stimulus control, cognitive restructuring and relaxation training. The efficacy of CCBT-i has been demonstrated in several randomized controlled trials involving patients with primary insomnia including one using GTS where the program was found to be superior to usual care (sleep hygiene instruction) after 6 weeks of therapy. Further, we recently conducted a pilot study comparing GTS and standard sleep hygiene instruction in Parkinson's disease patients with insomnia and found a greater reduction in ISI scores with CCBT-i (-7.9 vs -3.5; p=0.03).

Given the prevalence of insomnia in epilepsy and the known association between seizure occurrence and sleep impairment, the investigators hypothesize that treatment of insomnia with CCBT-i will improve insomnia symptoms and seizure control in PWE.

Conditions

Epilepsy; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Computerized Group

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

Group Type: OTHER

GoToSleep Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Nancy Foldvary-Schaefer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Foldvary-Schaefer, DO

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

18-242

Identifier Type: -

Identifier Source: org_study_id