InsomniaNCT01440777
Effectiveness and Adherence to an Online Sleep Program
A study testing Go! to Sleep in people with Insomnia, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Go! to Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Insomnia
- Being tested
- Go! to Sleep
- Keywords
- Insomnia, Sleep, Stress, Online program, Web-based program, Cognitive Behavioral Therapy for Insomnia (CBT-i)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go! to SleepBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Go! to Sleep | Active comparator | Participants access and utilize the 6-week online program that provides a set of various psycho-educational materials and behavioral techniques to treat insomnia. Receives: Behavioral: Go! to Sleep |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 months
Secondary outcomes (5)
Insomnia symptoms
To determine if the program helps improve insomnia symptoms as measured by the Pittsburgh Insomnia Rating Scale (PIRS)
Measured: 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)
Measured: 5 months
Daytime Dysfunction
To determine if the program improves daytime dysfunction (Pittsburgh Sleep Quality Index subscale)
Measured: 5 months
Stress
To assess whether the program reduces stress as measured by the Perceived Stress Scale (PSS10)
Measured: 5 months
Program adherence
To assess program adherence and its relation to program effectiveness
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Libertini, The Cleveland Clinic
- Investigators
- Adam Bernstein, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440777
- Sponsor's protocol ID
- IRB# 11-860
- Status last verified
- May 2022
- First submitted
- 23 Sep 2011
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Adherence to an Online Sleep Program - A Pilot Study
- ClinicalTrials.gov ID
- NCT01440777
- Acronym / sponsor ID
- IRB# 11-860
- Conditions
- Insomnia
- Keywords
- Insomnia, Sleep, Stress, Online program, Web-based program, Cognitive Behavioral Therapy for Insomnia (CBT-i)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Go! to Sleep | Active comparator | Behavioral: Go! to SleepParticipants access and utilize the 6-week online program that provides a set of various psycho-educational materials and behavioral techniques to treat insomnia. |
| Control Group | No intervention | –No intervention provided. These participants will receive the Go! to Sleep program after the research trial has been completed (10 weeks after registration). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Go! to SleepThe 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 | Behavioural | Go! to Sleep |
Primary outcome
Insomnia severity
Time frame: 5 months
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 secondary outcomes
Insomnia symptoms
Time frame: 5 months
Sleep pattern
Time frame: 5 months
Daytime Dysfunction
Time frame: 5 months
Stress
Time frame: 5 months
Program adherence
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Bernstein, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go! to Sleep in people with Insomnia, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.