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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

Tracking Information
First Submitted Date  ICMJE September 26, 2022
First Posted Date  ICMJE September 28, 2022
Last Update Posted Date November 16, 2022
Actual Study Start Date  ICMJE November 8, 2022
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2022)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2022)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)
Official Title  ICMJE Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Insomnia Disorder
Intervention  ICMJE Behavioral: somnovia
Participants receive access to the digital health application somnovia
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2022)
290
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05558865
Other Study ID Numbers  ICMJE somnovia-RCT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gaia AG
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gaia AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University Hospital Schleswig-Holstein
  • University Hospital Freiburg
Investigators  ICMJE
Principal Investigator: Robert Göder, Prof. Dr. Christian-Albrechts-Universität zu Kiel, Clinic for Psychiatry and Psychotherapy
PRS Account Gaia AG
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP