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

NCT ID: NCT02629913

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

mementor somnium

Group Type: EXPERIMENTAL

mementor somnium

Intervention Type: DEVICE

Waitlist

Group Type: OTHER

wait list

Intervention Type: OTHER

delayed access to mementor somnium

Interventions

mementor somnium

Intervention Type: DEVICE

wait list

delayed access to mementor somnium

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

mementor somnium

Identifier Type: -

Identifier Source: org_study_id