Effectiveness and Adherence to an Online Sleep Program

NeuroTherapia, Inc.

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Go! to Sleep

Study type: Interventional

Funder types: Other

Identifiers

NCT01440777

IRB# 11-860

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Go! to Sleep

Active Comparator group

Description:

Participants access and utilize the 6-week online program that provides a set of various psycho-educational materials and behavioral techniques to treat insomnia.

Treatment:

Behavioral: Go! to Sleep

Control Group

No Intervention group

Description:

No intervention provided. These participants will receive the Go! to Sleep program after the research trial has been completed (10 weeks after registration).