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

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT02629913
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 6.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Disorder	Device: mementor somnium; Other: wait list	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention mementor somnium	Device: mementor somnium
Other: Waitlist	Other: wait list; delayed access to mementor somnium

Outcome Measures

Primary Outcome Measures

1. Insomnia Severity Index [Six weeks]

Secondary Outcome Measures

1. Beck Depression Inventory [Six weeks]

2. Brief Symptom Inventory 18 [Six weeks]

3. SF-12 Health Survey [Six weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Zurich	Zurich		Switzerland	8050

Sponsors and Collaborators

• University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT02629913
• Other Study ID Numbers: mementor somnium
• First Posted: Dec 14, 2015
• Last Update Posted: Oct 18, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Oct 18, 2016