Insomniai-SleepNCT03110263
i-Sleep: Internet-based Treatment for Insomnia
A study testing Multicomponent internet-based self-help and Internet-based sleep restriction in people with Insomnia, run by University of Bern at 1 site in Switzerland.
Trial summary
In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Multicomponent internet-based self-help and Internet-based sleep restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jun 2016to 7 Jan 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Meet ICSD-3 diagnostic criteria for Insomnia as confirmed by the telephone administered Interview
- Acess to the Internet
- Written informed consent
Who cannot join
- Physiological Insomnia
- Serious psychiatric co-morbidity that requires alternative treatment including major depression disorder, anxiety disorder, substance dependence, bipolar affective disorder, psychotic illness
- Epilepsy (seizure disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: i-Sleep: Internet-based Treatment for Insomnia. A Randomized Controlled Trial
In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.
- Conditions
- Insomnia
- Being tested
- Multicomponent internet-based self-help, Internet-based sleep restriction
- 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.
Multicomponent internet-based self-helpOther
Internet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., \& Posner, D., 2006). The self-help program consists of eight text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment.
Internet-based sleep restrictionOther
Internet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., \& Posner, D., 2006). The self-help program consists of five text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent internet-based self-help | Experimental | Multicomponent internet-based self-help Receives: Other: Multicomponent internet-based self-help |
| Internet-based sleep restriction | Experimental | Internet-based sleep restriction Receives: Other: Internet-based sleep restriction |
| Waiting control group | No intervention | Access to internet-based intervention after 8-weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Measured: Baseline
Insomnia Severity Index (ISI)
Measured: 8-weeks
Insomnia Severity Index (ISI)
Measured: 6-months
Secondary outcomes (9)
Diagnosis of Insomnia
International Classification of Insomnia Disorders (ICSD-3)
Measured: Baseline, 8-weeks, 6-months
Sleep-diary: Sleep efficiency (SE)
Measured: 8-weeks
Sleep-Diary-data
Measured: 8-weeks
Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16)
Measured: Baseline, 8-weeks, 6-months
Patient satisfaction (ZUF-8)
Measured: 8-weeks
Empowerment Scale (ES)
Measured: Baseline, 8-weeks, 6-months
EuroQol
Measured: Baseline, 8-weeks, 6-months
Usability: Satisfaction with the online program (SUS)
Measured: 8-weeks
Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline, 8-weeks, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start10 Jun 2016
- Primary completion16 Aug 2017
- Study completion7 Jan 2018
Why it stopped: practicality reasons; recruitment slower than expected
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Thomas Berger, PhD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110263
- Sponsor's protocol ID
- 2016-00295
- Other IDs
- 2016
- Acronym
- i-Sleep
- Status last verified
- Jan 2019
- First submitted
- 28 Mar 2017
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- i-Sleep: Internet-based Treatment for Insomnia. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03110263
- Acronym / sponsor ID
- i-Sleep / 2016-00295
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: practicality reasons; recruitment slower than expected
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 7 Jan 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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.
In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multicomponent internet-based self-help | Experimental | Other: Multicomponent internet-based self-helpMulticomponent internet-based self-help |
| Internet-based sleep restriction | Experimental | Other: Internet-based sleep restrictionInternet-based sleep restriction |
| Waiting control group | No intervention | –Access to internet-based intervention after 8-weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years of age or older
- Meet ICSD-3 diagnostic criteria for Insomnia as confirmed by the telephone administered Interview
- Acess to the Internet
- Written informed consent
Key exclusion criteria (3 listed)
- Physiological Insomnia
- Serious psychiatric co-morbidity that requires alternative treatment including major depression disorder, anxiety disorder, substance dependence, bipolar affective disorder, psychotic illness
- Epilepsy (seizure disorder)
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 |
|---|---|---|
| Multicomponent internet-based self-helpInternet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., \& Posner, D., 2006). The self-help program consists of eight text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment. | Other | Multicomponent internet-based self-help |
| Internet-based sleep restrictionInternet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., \& Posner, D., 2006). The self-help program consists of five text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment. | Other | Internet-based sleep restriction |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline
Insomnia Severity Index (ISI)
Time frame: 8-weeks
Insomnia Severity Index (ISI)
Time frame: 6-months
9 secondary outcomes
Diagnosis of Insomnia
Time frame: Baseline, 8-weeks, 6-months
Sleep-diary: Sleep efficiency (SE)
Time frame: 8-weeks
Sleep-Diary-data
Time frame: 8-weeks
Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16)
Time frame: Baseline, 8-weeks, 6-months
Patient satisfaction (ZUF-8)
Time frame: 8-weeks
Empowerment Scale (ES)
Time frame: Baseline, 8-weeks, 6-months
EuroQol
Time frame: Baseline, 8-weeks, 6-months
Usability: Satisfaction with the online program (SUS)
Time frame: 8-weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 8-weeks, 6-months
Results and safety
The study was stopped early (reason given: practicality reasons; recruitment slower than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Thomas Berger, PhD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent internet-based self-help and Internet-based sleep restriction in people with Insomnia, run by University of Bern at 1 site in Switzerland.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Jan 2019. 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 Switzerland. 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 was stopped early (reason given: practicality reasons; recruitment slower than expected). Results are not available in the source record.
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 Index (ISI) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 14 Jan 2019.