Back to resultsEffectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)
Primary Purpose
Insomnia Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
somnovia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia Disorder
Eligibility Criteria
Inclusion Criteria:
- diagnosis of chronic insomnia
- impaired quality of sleep (Insomnia Severity Index Score ≥ 10)
Exclusion Criteria:
- none
Sites / Locations
- GAIA AG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
somnovia
Care as Usual
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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)
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".
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
Remission Rate on Insomnia Severity Index
Remission is defined as patients with a total score on the Insomnia Severity Index of < 8
Full Information
NCT ID
NCT05558865
First Posted
September 26, 2022
Last Updated
September 22, 2023
Sponsor
Gaia AG
Collaborators
University Hospital Schleswig-Holstein, University Hospital Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT05558865
Brief Title
Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)
Official Title
Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
September 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaia AG
Collaborators
University Hospital Schleswig-Holstein, University Hospital Freiburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
somnovia
Arm Type
Experimental
Arm Description
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.
Arm Title
Care as Usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
somnovia
Intervention Description
Participants receive access to the digital health application somnovia
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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).
Time Frame
3 months after randomization
Secondary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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).
Time Frame
6 months after randomization
Title
Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
3 months and 6 months after randomization
Title
Generalized Anxiety Disorder Assessment (GAD-7)
Description
The GAD-7 is a self-administered patient questionnaire used as a screening tool and severity measure for generalized anxiety disorder (GAD)
Time Frame
3 months and 6 months after randomization
Title
Work and Social Assessment Scale (WSAS)
Description
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".
Time Frame
3 months and 6 months after randomization
Title
Responder Rate on Insomnia Severity Index
Description
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
Time Frame
3 months after randomization
Title
Remission Rate on Insomnia Severity Index
Description
Remission is defined as patients with a total score on the Insomnia Severity Index of < 8
Time Frame
3 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of chronic insomnia
impaired quality of sleep (Insomnia Severity Index Score ≥ 10)
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Göder, Prof. Dr.
Organizational Affiliation
Christian-Albrechts-Universität zu Kiel, Clinic for Psychiatry and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
GAIA AG
City
Hamburg
ZIP/Postal Code
20144
Country
Germany
12. IPD Sharing Statement
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Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)
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