Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?
Primary Purpose
Insomnia Disorder
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
mementor somnium
wait list
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia Disorder
Eligibility Criteria
Inclusion Criteria:
- Insomnia Disorder (DSM-5)
- German language comprehension
- Internet-access
Exclusion Criteria:
- Other sleep disorder
- Suicidality
- Current psychotherapy
- Drug abuse or recent change in medication
Sites / Locations
- University of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Waitlist
Arm Description
mementor somnium
Outcomes
Primary Outcome Measures
Insomnia Severity Index
Secondary Outcome Measures
Beck Depression Inventory
Brief Symptom Inventory 18
SF-12 Health Survey
Full Information
NCT ID
NCT02629913
First Posted
December 10, 2015
Last Updated
October 17, 2016
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT02629913
Brief Title
Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief Summary
The Swiss company mementor has recently developed an interactive self-help intervention for the treatment of insomnia entitled mementor somnium. This programme is based on the guidelines for cognitive-behavioural therapy. mementor somnium consists of 6 online sessions. An animated personal sleep coach provides relevant audio-information and asks questions to which the patient is invited to respond. The components of the programme flexibly adapt to the patient's responses. Aside from psycho-education, exercises and an instruction for sleep restriction, mementor somnium includes a cognitive restructuring intervention in terms of a Socratic dialogue. This Socratic dialogue, implemented by the animated sleep coach, is based on a complex algorithm in the shape of an decision tree. University of Zurich's Department of Psychology in Switzerland will test the effectiveness of mementor somnium in a randomised controlled trial with three assessment times (pre, 6-weeks post and 3-months follow-up). Patients suffering from insomnia will be allocated randomly to either the active intervention group or the waitlist control group. Participants will have access to the programme mementor somnium for six weeks. Primary outcome measure is the Insomnia Severity Index, secondary outcome measures are Beck Depressions-Inventory revised (BDI-II), Brief Symptom Inventory 18, and the SF-12 Health Survey. Additionally, sleep diary data will be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
mementor somnium
Arm Title
Waitlist
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
mementor somnium
Intervention Type
Other
Intervention Name(s)
wait list
Intervention Description
delayed access to mementor somnium
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
Six weeks
Title
Brief Symptom Inventory 18
Time Frame
Six weeks
Title
SF-12 Health Survey
Time Frame
Six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Insomnia Disorder (DSM-5)
German language comprehension
Internet-access
Exclusion Criteria:
Other sleep disorder
Suicidality
Current psychotherapy
Drug abuse or recent change in medication
Facility Information:
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8050
Country
Switzerland
12. IPD Sharing Statement
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Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?
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