A Computerized CBTi for Insomnia in Epilepsy

Conditions:Insomnia Sleep Studies, Neurology, Epilepsy
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Age Range:18 - Any
Start Date:July 24, 2018
End Date:July 23, 2020
Contact:Monica Bruton

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A Computerized Cognitive Behavioral Therapy (CBTi) Randomized, Controlled, Pilot Trial for Insomnia in Epilepsy

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).

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.

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.
We found this trial at
Cleveland, Ohio 44195
Principal Investigator: Thapanee Somboon, MD
Phone: 216-444-6718
Cleveland, OH
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