Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)

Study Overview
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Brief Summary
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The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual [CAU]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.

Official Title
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Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial

Conditions
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Insomnia Disorder

Intervention / Treatment
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* Behavioral: somnovia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of chronic insomnia impaired quality of sleep (Insomnia Severity Index Score ≥ 10) Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: somnovia<br>somnovia is a digital health application for people with Insomnia Disorder. Content is continuously adapted to patients' concerns and needs. somnovia is a comprehensive program, which is conceptually and substantially based on the Cognitive Behavioral Therapy for Insomnia (CBT-I) used in patients with Insomnia Disorder. It contains interactive dialogues that can be accessed via computer or smartphone, illustrations, audio recordings and motivating text messages. Techniques to cope with insomnia symptoms (e.g., psychoeducation about causes and basic emotional needs in addition to relevant strategies to improve sleep quality) are conveyed in interactive sequences that are accompanied by audio recordings, illustrations, and worksheets. Patients are also prompted to regularly complete brief symptom severity self-monitoring questionnaires. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration. | Behavioral: somnovia<br>* Participants receive access to the digital health application somnovia<br>|
| No Intervention: Care as Usual<br>Care as Usual: In the CAU control group, participants are free to continue to engage with any treatment they require. However, they will be offered access to somnovia after 6 months post-baseline. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem). | 3 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem). | 6 months after randomization | 
| Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a well-validated nine-item self-report questionnaire developed to score each of the nine DSM-IV criteria for major depressive disorder on a 4-point Likert scale, from 0 (not at all) to 3 (nearly every day). | 3 months and 6 months after randomization | 
| Generalized Anxiety Disorder Assessment (GAD-7) | The GAD-7 is a self-administered patient questionnaire used as a screening tool and severity measure for generalized anxiety disorder (GAD) | 3 months and 6 months after randomization | 
| Work and Social Assessment Scale (WSAS) | WSAS is a 5-item self-report scale to measure the ability to work in regard to physical, mental and social health as well as age group referenced competence for performance. Each item is rated on a 9-point Likert scale from 0 = not at all impaired to 8 = very severely impaired. | 3 months and 6 months after randomization | 
| Responder Rate on Insomnia Severity Index | A Responder is defined as a patient with an improvement of > 6 points on the total score of the Insomnia Severity Index from T0 to T1 | 3 months after randomization | 
| Remission Rate on Insomnia Severity Index | Remission is defined as patients with a total score on the Insomnia Severity Index of < 8 | 3 months after randomization |