Insomnia Disorder
Conditions
Brief summary
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.
Interventions
BEHAVIORALsomnovia
Participants receive access to the digital health application somnovia
Sponsors
University Hospital Schleswig-Holstein
University Hospital Freiburg
Gaia AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of chronic insomnia * impaired quality of sleep (Insomnia Severity Index Score ≥ 10)
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 3 months after randomization | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | 3 months and 6 months after randomization | 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). |
| Generalized Anxiety Disorder Assessment (GAD-7) | 3 months and 6 months after randomization | The GAD-7 is a self-administered patient questionnaire used as a screening tool and severity measure for generalized anxiety disorder (GAD) |
| Insomnia Severity Index (ISI) | 6 months after randomization | 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). |
| Responder Rate on Insomnia Severity Index | 3 months after randomization | 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 |
| Remission Rate on Insomnia Severity Index | 3 months after randomization | Remission is defined as patients with a total score on the Insomnia Severity Index of \< 8 |
| Work and Social Assessment Scale (WSAS) | 3 months and 6 months after randomization | 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. |
Countries
Germany
Outcome results
None listed