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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
Sponsor:
Collaborators:
University Hospital Schleswig-Holstein
University Hospital Freiburg
Information provided by (Responsible Party):
Gaia AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Disorder Behavioral: somnovia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: somnovia
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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)

  4. 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".

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Anja C Specht, M.Sc. 004940 349930 ext 167 anja.specht@gaia-group.com
Contact: Gitta Jacob, PD Dr. gitta.jacob@gaia-group.com

Locations
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Germany
GAIA AG Recruiting
Hamburg, Germany, 20144
Contact: Anja C Specht, M.Sc.       anja.specht@gaia-group.com   
Sponsors and Collaborators
Gaia AG
University Hospital Schleswig-Holstein
University Hospital Freiburg
Investigators
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Principal Investigator: Robert Göder, Prof. Dr. Christian-Albrechts-Universität zu Kiel, Clinic for Psychiatry and Psychotherapy
More Information
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Responsible Party: Gaia AG
ClinicalTrials.gov Identifier: NCT05558865    
Other Study ID Numbers: somnovia-RCT
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders