F51.0 G47.0
Conditions
Interventions
Group 1: Arm 1: SleepQ Intervention Group
Usage of the SleepQ app by the participant as an add-on to CAU for 12 weeks. Within the context of CAU, participants may continue their current treatment and,
Sponsors
WELT Corp., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult participants =18 years old 2. Current diagnosis of chronic insomnia confirmed by a physician. Insomnia defined by the following ICD-10 codes: a. F51.0 Nonorganic insomnia, or b. G47.0 Insomnia 3. Possession of a mobile device with internet connection (must be run on iOS software, minimum version 18 or Android OS minimum version 12) 4. Sufficient German language proficiency required for the correct use of the intervention and the mobile device 5. Personal e-mail address for registration 6. Willing and able to provide written informed consent 7. Insomnia Severity Index (ISI) score of 15 or higher, indicating clinically relevant symptoms of insomnia
Exclusion criteria
Exclusion criteria: 1. Use of a digital intervention for insomnia treatment in the past 3 months or planned use of comparable digital intervention during the study period 2. PHQ-9 score at screening =20 and/or item 9 of PHQ-9 = 1 3. GAD-7 score at screening =15 4. Intermittent use and / or recent initiation (< 3m) or planned use of insomnia specific prescription-only pharmacological therapy 5. Intermittent use and / or recent initiation (< 3m) or planned use of a psychotropic during the study period which has recognised potential effects on insomnia 6. Participation in CBT or other psychotherapy to treat sleep disorders in the last 3 months (outpatient, inpatient) or planned start during the study period 7. Known history or diagnosis of substance or alcohol abuse or dependence within 12 months prior to screening (diagnosis of F10-F19, excluding F17.1 and F17.2) 8. Current or planned participation in other clinical trials during the study period 9. Working in shifts (Non-traditional shifts outside "regular" 9:00 am to 5:00 pm hours) 10. Currently pregnant or planning to become pregnant within the next 3 months 11. Any surgical procedure that was scheduled, planned, or conducted within the timeframe of the study (minor outpatient procedures under local anaesthetic or with no anesthetic are permitted) 12. Diagnosis of epilepsy 13. Presence of a serious mental illness, such as (schizophrenia F 20.-, acute transient psychotic disorders F23.-, active manic episode F30.-, bipolar disorder F31.-, severe depression F32.3, F33.3, F32.2, F33.2, F32.1 and F33.1) 14. Other diseases (such as acute or severe cardiac diseases, acute or severe respiratory diseases, acute or severe gastrointestinal diseases), conditions or therapies which, in the opinion of the investigator, could confound the study results or contraindicate participation. 15. Acute suicidal thoughts or intentions within the past 12 months 16. Presence of obstructive sleep apnea, restless legs syndrome, parasomnia, and other sleep behavior problem 17. Any condition or circumstance that, in the opinion of the Principal Investigator or designee, would compromise the participant's ability to comply with the study CIP, pose an unacceptable risk to the participant's safety or well-being, or interfere with the evaluation of study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of insomnia symptoms measured by the Insomnia Severity Index (ISI) from baseline to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) from baseline to 12 weeks - Change in anxiety symptoms measured by the Generalized Anxiety Disorder (GAD-7) from baseline to 12 weeks - Change in dysfunctional beliefs measured by the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS) from baseline to 12 weeks - Daily functioning measured by the Work and Social Adjustment Scale (WSAS) from baseline to 12 weeks - Change in quality of life measured by the EuroQol Visual Analog Scale (EQ-VAS) from baseline to 12 weeks | — |
Countries
Germany
Contacts
Public ContactStefan Gutwinski
Lindus Health Virtual Site
Outcome results
None listed