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i-Sleep: Internet-based Treatment for Insomnia (i-Sleep)

Primary Purpose

Insomnia

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Multicomponent internet-based self-help
Internet-based sleep restriction
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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)

Sites / Locations

  • University of Bern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Multicomponent internet-based self-help

Internet-based sleep restriction

Waiting control group

Arm Description

Multicomponent internet-based self-help

Internet-based sleep restriction

Access to internet-based intervention after 8-weeks

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI)

Secondary Outcome Measures

Diagnosis of Insomnia
International Classification of Insomnia Disorders (ICSD-3)
Sleep-diary: Sleep efficiency (SE)
Sleep-Diary-data
Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16)
Patient satisfaction (ZUF-8)
Empowerment Scale (ES)
EuroQol
Usability: Satisfaction with the online program (SUS)
Pittsburgh Sleep Quality Index (PSQI)

Full Information

First Posted
March 28, 2017
Last Updated
January 10, 2019
Sponsor
University of Bern
Collaborators
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03110263
Brief Title
i-Sleep: Internet-based Treatment for Insomnia
Acronym
i-Sleep
Official Title
i-Sleep: Internet-based Treatment for Insomnia. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
practicality reasons; recruitment slower than expected
Study Start Date
June 10, 2016 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
January 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multicomponent internet-based self-help
Arm Type
Experimental
Arm Description
Multicomponent internet-based self-help
Arm Title
Internet-based sleep restriction
Arm Type
Experimental
Arm Description
Internet-based sleep restriction
Arm Title
Waiting control group
Arm Type
No Intervention
Arm Description
Access to internet-based intervention after 8-weeks
Intervention Type
Other
Intervention Name(s)
Multicomponent internet-based self-help
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Internet-based sleep restriction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Time Frame
Baseline
Title
Insomnia Severity Index (ISI)
Time Frame
8-weeks
Title
Insomnia Severity Index (ISI)
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Diagnosis of Insomnia
Description
International Classification of Insomnia Disorders (ICSD-3)
Time Frame
Baseline, 8-weeks, 6-months
Title
Sleep-diary: Sleep efficiency (SE)
Time Frame
8-weeks
Title
Sleep-Diary-data
Time Frame
8-weeks
Title
Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16)
Time Frame
Baseline, 8-weeks, 6-months
Title
Patient satisfaction (ZUF-8)
Time Frame
8-weeks
Title
Empowerment Scale (ES)
Time Frame
Baseline, 8-weeks, 6-months
Title
EuroQol
Time Frame
Baseline, 8-weeks, 6-months
Title
Usability: Satisfaction with the online program (SUS)
Time Frame
8-weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline, 8-weeks, 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Berger, PhD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

i-Sleep: Internet-based Treatment for Insomnia

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