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The goal of this clinical trial is to learn whether the SleepQ mobile app can help reduce insomnia symptoms in adults diagnosed with insomnia. The main questions it aims to answer are:
Researchers will compare CAU + SleepQ to CAU alone to see whether SleepQ provides additional benefits for sleep and well-being.
Participants will take part remotely from home, be randomly assigned to either SleepQ+CAU or CAU alone, and complete online questionnaires at baseline, week 6, and week 12 about their sleep, mood, and daily functioning.
Participants in the intervention group will use the SleepQ app for 12 weeks while continuing their usual care.
SleepQ is digital CBT-I application developed to align with national clinical guidelines for the treatment of sleep disorders. The program includes psychoeducation, sleep restriction therapy, stimulus control, sleep hygiene approaches, cognitive restructuring, and relaxation exercises. The app also incorporates a digital sleep diary, personalized sleep timing recommendations, interactive learning modules, quizzes to reinforce concepts, and monitoring of therapy progress. The overall design aims to support engagement and autonomous adherence to CBT-I principles by providing step-by-step guidance and feedback throughout the therapeutic course.
The pilot clinical trial will evaluate the effectiveness of SleepQ as an add-on to care as usual (CAU) compared with CAU alone in adults diagnosed with insomnia. Approximately 80 adult participants with a confirmed diagnosis of insomnia will be enrolled and randomized in a 1:1 ratio to the intervention group (SleepQ + CAU) or the control group (CAU alone). The study will be conducted as a fully decentralized trial within Germany. Screening, informed consent, eligibility confirmation, randomization, and all outcome assessments will be conducted remotely. Participants will complete self-reported questionnaires at baseline, week 6, and week 12 to assess changes in insomnia severity and related symptoms.
The primary endpoint is the reduction in insomnia symptoms after 12 weeks, and secondary outcomes include changes in depressiv symptoms, anxiety, dysfunctional beliefs about sleep, and daily functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) | Experimental |
| |
| Care-as-Usual (CAU) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) | Behavioral | SleepQ is a fully digital, individualized 12-week cognitive behavioral therapy program for adults with insomnia. The intervention is delivered via the SleepQ mobile application and includes structured CBT-I components such as sleep restriction therapy, stimulus control, psychoeducation, cognitive restructuring, sleep hygiene training, and daily sleep diary input, in addition to Care-as-Usual (CAU). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity Index (ISI) Score from Baseline to Week 12 | The Insomnia Severity Index (ISI) is a 7-item validated self-report questionnaire assessing the severity and impact of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating more severe insomnia. ISI is administered at baseline and week 12. The outcom is calculated a the change in total ISI score from baseline to week 12. | From baseline to 12 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) Score from Baseline to Week 12 | The PHQ-9 is a 9-item validated self-report measure of depressive symptoms. Each item is scored from 0 to 3, producing a total score from 0 to 27, with higher scores indicating more severe depression. The outcome is the change in total PHQ-9 score from baseline to week 12. | From baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Satisfaction With the SleepQ App From Intervention Start to Week 12 | Patient satisfaction with the SleepQ digital intervention will be assessed in the intervention group using a validated satisfaction quesitonnaire based on the Second Ordinance Amending the Digital Health Applications Ordinance (BfArM, 2025) The questionnaire includes five items rated on a 0-10 Likert-type scale:
For Items 1-4, higher scores indicate stronger agreement (0 = does not apply at all; 10 = extremely likely). For Item 5, higher scores indicate greater likelihood of recommendation (0 = extremely unlikely; 10 = extremely likely). Scores will be analyzed as change from intervention start. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujin Lee | Contact | +82-2-6439-0707 | info@weltcorp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin Medical Association (Ärztekammer Berlin) | Berlin | 10969 | Germany |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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|
| Change in Generalized Anxiety Disorder-7 (GAD-7) Score from Baseline to Week 12 | The GAD-7 is a 7-item validated self-report measure of anxiety symptoms. Each item is scored from 0 to 3, yielding a total score from 0 to 21, with higher scores indicating more severe anxiety. The outcome is the change in total GAD-7 score from baseline to week 12. | From baseline to week 12 |
| Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) Score from Baseline to Week 12 | The DBAS-16 is a 16-item self-report scale assessing maladaptive sleep-related beliefs. Items are rated from 0 (strongly disagree) to 10 (strongly agree). The total score is the mean of all items and ranges from 0 to 10, with higher scores indicating stronger dysfunctional beliefs. The outcome is the change in mean DBAS-16 score from baseline to week 12. | From baseline to week 12 |
| Change in Work and Social Adjustment Scale (WSAS) Score from Baseline to Week 12 | The WSAS is a 5-item self-report measure assessing functional impairment across work, home management, social activities, and relationships. Each item is scored from 0 (no impairment) to 8 (severe impairment), producing a total score from 0 to 40. Higher scores indicate greater functional impairment. The outcome is the change in total WSAS score from baseline to week 12. | From baseline to week 12 |
| Change in EuroQol Visual Analog Scale (EQ-VAS) Score from Baseline to Week 12 | The EQ-VAS is a self-rated measure of overall health-related quality of life. Participants rate their current health on a 0 to 100 visual analog scale, where 0 indicates the worst imaginable health and 100 the best imaginable health. The outcome is the change in EQ-VAS score from baseline to week 12. | From baseline to week 12 |
| From intervention start (code activation) to week 12 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |