Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?

Not Applicable

Completed

• Conditions: Insomnia Disorder
• Interventions: Device: mementor somnium; Other: wait list

• Registration Number: NCT02629913
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-14
• Study Start: 2016-01
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	mementor somnium	mementor somnium
Waitlist	wait list	-

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Six weeks

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory	Six weeks
Brief Symptom Inventory 18	Six weeks
SF-12 Health Survey	Six weeks

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland