Clinical trial NCT01440777: Effectiveness and Adherence to an Online Sleep Program
Official title: Effectiveness and Adherence to an Online Sleep Program - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Sleep
Stress
Online program
Web-based program
Cognitive Behavioral Therapy for Insomnia (CBT-i)
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This research will examine the effectiveness of a 6-week online sleep program (Go! To Sleep) which provides a set of various psycho-educational materials and behavioral techniques to reduce insomnia symptoms, improve sleep, and improve quality of life.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years old.
* Currently living in the continental United States and Canada.
* Symptoms of insomnia based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) definition of insomnia disorder:

  * Self-reported sleep difficulties (including sleep-onset latency, waking after sleep onset, early waking of more than 30 min duration) 3 or more times a week in the past 3 months.
  * Self-reported insomnia problem for more than 3 months.
  * Self-reported significant daytime impairment due to sleep difficulties.
* Willingness to log onto the internet on a regular basis for the duration of the study (3-7 months).
* Willingness and able to complete almost daily a sleep log to track sleep pattern for up to 2 months at a time (approximately 2-3 min daily).
* Willingness to be in the Wait-list control group and not have access to the program for 3 months.

Exclusion Criteria:

* Pregnant or planning to be pregnant in the next 6 months.
* Lack of internet access and/or Mac computer at place of residence.
* Currently participating or have participated in group or individual therapy for insomnia in the prior month.
* Patient Health Questionnaire (PHQ9) depression score \>14.
* Recent treatment (less than 3 months) or medication for depression or anxiety.
* Change in treatment or medication for depression or anxiety in the past month or planned change in the next 3 months.
* Current treatment (therapy, prescription) for any other psychological or emotional conditions (including but not limited to: mania, manic-depression, psychosis, schizophrenia, adjustment disorder).
* Diagnosed and currently suffering from a sleep disorder (including, but not limited to sleep apnea, restless leg syndrome, sleep walking, narcolepsy) which is untreated or has been treated for less than a month.
* Suffer from physical symptoms or medical conditions that may affect sleep (including but not limited to: pain, arthritis, tinnitus, diabetes, night time cough, shortness of breath, hot flashes, frequent urination, heartburn).
* Steroid an stimulant use (including but not limited to prednisone, methylprednisolone or Solumedrol (for inflammatory disorders), methylphenidate, or Ritalin (for Attention-Deficit Hyperactivity disorder), Provigil (for narcolepsy), Wellbutrin or Zyban (for tobacco cessation), cocaine or methylenedioxymethamphetamine (MDMA) (a.k.a. Ecstasy)).
* Irregular workshift.
* Having young children who may affect sleep pattern.
* Taking over-the-counter or prescribed sleep medication 3 or more times a week.
* Alcoholism.
* Inability to access the internet on a consistent regular basis for the duration of the study (3-7 months).
* Inability to complete daily sleep log to track sleep patterns for up to 2 months at a time.
* Unwillingness to be assigned to the wait-list control group for 3 months prior to gaining access to the program.

Primary outcomes:
measure: Insomnia severity
timeFrame: 5 months
Secondary outcomes:
measure: Insomnia symptoms
timeFrame: 5 months
measure: Sleep pattern
timeFrame: 5 months
measure: Daytime Dysfunction
timeFrame: 5 months
measure: Stress
timeFrame: 5 months
measure: Program adherence
timeFrame: 5 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Adam Bernstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References: