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Completed

NCT Number: NCT02629913

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich

Zurich, 8050, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mementor somnium

Device

wait list

Other

delayed access to mementor somnium

Primary outcomes

  1. Insomnia Severity Index

    Time frame: Six weeks

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: Six weeks

  2. Brief Symptom Inventory 18

    Time frame: Six weeks

  3. SF-12 Health Survey

    Time frame: Six weeks

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2015
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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