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TerminatedNCT03110263i-SleepUpdated Jan 14, 2019

i-Sleep: Internet-based Treatment for Insomnia

An interventional study of Multicomponent internet-based self-help and Internet-based sleep restriction in Insomnia, sponsored by University of Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-14.

Sponsored by University of Bern · Not applicable, Interventional, and Treatment

Why this study was terminated
practicality reasons; recruitment slower than expected

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jun 2016, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

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In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 104 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
104 participants (actual)

Study arms

  • Experimental
    Multicomponent internet-based self-help

    Multicomponent internet-based self-help

    Other: Multicomponent internet-based self-help

  • Experimental
    Internet-based sleep restriction

    Internet-based sleep restriction

    Other: Internet-based sleep restriction

  • No intervention
    Waiting control group

    Access to internet-based intervention after 8-weeks

Interventions

  • OtherMulticomponent internet-based self-help

    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.

  • OtherInternet-based sleep restriction

    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.

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What researchers measure

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Baseline

  2. Insomnia Severity Index (ISI)

    Time frame: 8-weeks

  3. Insomnia Severity Index (ISI)

    Time frame: 6-months

Secondary outcomes

  1. Diagnosis of Insomnia

    International Classification of Insomnia Disorders (ICSD-3)

    Time frame: Baseline, 8-weeks, 6-months

  2. Sleep-diary: Sleep efficiency (SE)

    Time frame: 8-weeks

  3. Sleep-Diary-data

    Time frame: 8-weeks

  4. Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16)

    Time frame: Baseline, 8-weeks, 6-months

  5. Patient satisfaction (ZUF-8)

    Time frame: 8-weeks

  6. Empowerment Scale (ES)

    Time frame: Baseline, 8-weeks, 6-months

  7. EuroQol

    Time frame: Baseline, 8-weeks, 6-months

  8. Usability: Satisfaction with the online program (SUS)

    Time frame: 8-weeks

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, 8-weeks, 6-months

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Study locations

1 site
  • University of Bern
    Bern, 3012, Switzerland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03110263
Lead sponsor
University of Bern
Collaborators
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Apr 12, 2017
Start date
Jun 10, 2016
Primary completion
Aug 16, 2017
Completion
Jan 7, 2018
Last update
Jan 14, 2019

Study contacts

Thomas Berger, PhD
principal investigator · University of Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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