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

NCT05558865 | Completed

• 1 other identifier: somnovia-RCT
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months after randomization

Secondary Outcomes (6)

• Insomnia Severity Index (ISI)

  6 months after randomization

• Patient Health Questionnaire (PHQ-9)

  3 months and 6 months after randomization

• Generalized Anxiety Disorder Assessment (GAD-7)

  3 months and 6 months after randomization

• Work and Social Assessment Scale (WSAS)

  3 months and 6 months after randomization

• Responder Rate on Insomnia Severity Index

  3 months after randomization

Study Arms (2)

somnovia

EXPERIMENTAL

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

Care as Usual

NO INTERVENTION

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.

Interventions

somnovia BEHAVIORAL

Participants receive access to the digital health application somnovia

somnovia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Gaia AG: lead
• University Hospital Schleswig-Holstein: collaborator
• University Hospital Freiburg: collaborator

Study Sites (1)

GAIA AG

Hamburg, 20144, Germany

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Robert Göder, Prof. Dr.

  Christian-Albrechts-Universität zu Kiel, Clinic for Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 28, 2022
• Study Start: November 8, 2022
• Primary Completion: May 22, 2023
• Study Completion: September 18, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-06

Locations

DE (1)