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Clinical Trial: A Computerized Cognitive Behavioral Therapy for Insomnia in Epilepsy

August 16, 2018

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).

Study start date: July 24, 2018
Estimated study completion date: July 23, 2020

Eligibility Criteria:

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

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.