Effectiveness and Adherence to an Online Sleep Program

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Go! to Sleep

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Go! to Sleep; Participants access and utilize the 6-week online program that provides a set of various psycho-educational materials and behavioral techniques to treat insomnia.	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
No Intervention: Control Group; No intervention provided. These participants will receive the Go! to Sleep program after the research trial has been completed (10 weeks after registration).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia symptoms	To determine if the program helps improve insomnia symptoms as measured by the Pittsburgh Insomnia Rating Scale (PIRS)	5 months
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
Daytime Dysfunction	To determine if the program improves daytime dysfunction (Pittsburgh Sleep Quality Index subscale)	5 months
Stress	To assess whether the program reduces stress as measured by the Perceived Stress Scale (PSS10)	5 months
Program adherence	To assess program adherence and its relation to program effectiveness	5 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Adam Bernstein, M.D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimate): September 27, 2011

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Stress; Sleep; Insomnia; Web-based program; Online program; Cognitive Behavioral Therapy for Insomnia (CBT-i)
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IRB# 11-860