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

Not Applicable

Completed

• Conditions: Insomnia Disorder
• Interventions: Behavioral: somnovia

• Registration Number: NCT05558865
• Lead Sponsor: Gaia AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-28
• Study Start: 2022-11-08
• Primary Completion: 2023-05-22
• Status Verified: 2023-06
• Study Completion: 2023-09-18
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• diagnosis of chronic insomnia
• impaired quality of sleep (Insomnia Severity Index Score ≥ 10)

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
somnovia	somnovia	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
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
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)
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".

Trial Locations

Locations (1)

GAIA AG; 🇩🇪 Hamburg, Germany