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

NCT02629913 | Completed

• 1 other identifier: mementor somnium
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  Six weeks

Secondary Outcomes (3)

• Beck Depression Inventory

  Six weeks

• Brief Symptom Inventory 18

  Six weeks

• SF-12 Health Survey

  Six weeks

Study Arms (2)

Intervention

EXPERIMENTAL

mementor somnium

Device: mementor somnium

Waitlist

OTHER

Other: wait list

Interventions

mementor somnium DEVICE

Intervention

wait list OTHER

delayed access to mementor somnium

Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Insomnia Disorder (DSM-5)
• German language comprehension
• Internet-access

You may not qualify if:

• Other sleep disorder
• Suicidality
• Current psychotherapy
• Drug abuse or recent change in medication

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University of Zurich

Zurich, 8050, Switzerland

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

CH (1)