Effectiveness and Adherence to an Online Sleep Program

NCT ID: NCT01440777

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-06-30

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Go! to Sleep

Intervention Type: BEHAVIORAL

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

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Linda Libertini

Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam Bernstein, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

IRB# 11-860

Identifier Type: -

Identifier Source: org_study_id