Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)
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|ClinicalTrials.gov Identifier: NCT05558865|
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : November 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Disorder||Behavioral: somnovia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial|
|Actual Study Start Date :||November 8, 2022|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||July 2023|
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.
Participants receive access to the digital health application somnovia
No Intervention: Care as Usual
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.
- Insomnia Severity Index (ISI) [ Time Frame: 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).
- Insomnia Severity Index (ISI) [ Time Frame: 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).
- Patient Health Questionnaire (PHQ-9) [ Time Frame: 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) [ Time Frame: 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)
- Work and Social Assessment Scale (WSAS) [ Time Frame: 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".
- Responder Rate on Insomnia Severity Index [ Time Frame: 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 [ Time Frame: 3 months after randomization ]Remission is defined as patients with a total score on the Insomnia Severity Index of < 8
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558865
|Contact: Anja C Specht, M.Sc.||004940 349930 ext firstname.lastname@example.org|
|Contact: Gitta Jacob, PD Dr.||email@example.com|
|Hamburg, Germany, 20144|
|Contact: Anja C Specht, M.Sc. firstname.lastname@example.org|
|Principal Investigator:||Robert Göder, Prof. Dr.||Christian-Albrechts-Universität zu Kiel, Clinic for Psychiatry and Psychotherapy|