Effectiveness and Adherence to an Online Sleep Program

Insomnia Clinical Trial

Official title:

Effectiveness and Adherence to an Online Sleep Program - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440777
• Other study ID #: IRB# 11-860
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: June 2014

Study information

• Verified date: May 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Go! to Sleep
The online program provides various tools for the delivery of the intervention including: Daily articles Daily activities to help get the sleep you need Daily sleep improvement recommendations Audio recorded relaxation exercises Daily e-mails from your program coach Personal progress charts An online sleep log and daily sleep score

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia severity	To assess the effectiveness of the online Go! to Sleep program in improving sleep by measuring insomnia severity using the Insomnia Severity Index (ISI).	5 months
Secondary	Insomnia symptoms	To determine if the program helps improve insomnia symptoms as measured by the Pittsburgh Insomnia Rating Scale (PIRS)	5 months
Secondary	Sleep pattern	To determine if the program helps improve sleep-onset latency (SOL), total sleep time (TST), waking after sleep onset (WASO) (within Go To Sleep! group analysis only)	5 months
Secondary	Daytime Dysfunction	To determine if the program improves daytime dysfunction (Pittsburgh Sleep Quality Index subscale)	5 months
Secondary	Stress	To assess whether the program reduces stress as measured by the Perceived Stress Scale (PSS10)	5 months
Secondary	Program adherence	To assess program adherence and its relation to program effectiveness	5 months