Insomnia DisorderNCT02629913
Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?
A study testing mementor somnium and wait list in people with Insomnia Disorder, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- mementor somnium and wait list
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insomnia Disorder (DSM-5)
- German language comprehension
- Internet-access
Who cannot join
- Other sleep disorder
- Suicidality
- Current psychotherapy
- Drug abuse or recent change in medication
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- mementor somnium, wait list
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mementor somniumDevice
wait listOther
delayed access to mementor somnium
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | mementor somnium Receives: Device: mementor somnium |
| Waitlist | Other | Not described Receives: Other: wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Measured: Six weeks
Secondary outcomes (3)
Beck Depression Inventory
Measured: Six weeks
Brief Symptom Inventory 18
Measured: Six weeks
SF-12 Health Survey
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629913
- Sponsor's protocol ID
- mementor somnium
- Status last verified
- Oct 2016
- First submitted
- 10 Dec 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?
- ClinicalTrials.gov ID
- NCT02629913
- Acronym / sponsor ID
- mementor somnium
- Conditions
- Insomnia Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: mementor somniummementor somnium |
| Waitlist | Other | Other: wait list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Insomnia Disorder (DSM-5)
- German language comprehension
- Internet-access
Key exclusion criteria (4 listed)
- Other sleep disorder
- Suicidality
- Current psychotherapy
- Drug abuse or recent change in medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mementor somnium | Device | Intervention |
| wait listdelayed access to mementor somnium | Other | Waitlist |
Primary outcome
Insomnia Severity Index
Time frame: Six weeks
3 secondary outcomes
Beck Depression Inventory
Time frame: Six weeks
Brief Symptom Inventory 18
Time frame: Six weeks
SF-12 Health Survey
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mementor somnium and wait list in people with Insomnia Disorder, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.