An interventional study of SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in Insomnia, sponsored by WELT corp. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by WELT corp · Not applicable, Interventional, and Treatment
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 80 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →WELT corp is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
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).
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.
Time frame: From baseline to 12 weeks after enrollment
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.
Time frame: From baseline to week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to week 12
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: 1. I was able to easily understand the DiGA. 2. The DiGA functioned reliably. 3. When I had questions, I received support easily and without complications. 4. The DiGA helped me understand my condition better than before. 5. How likely is it that you would recommend this DiGA to friends and family? 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.
Time frame: From intervention start (code activation) to week 12
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2025; primary completion for Jul 2026, 7 months later.
Of 78 industry-sponsored interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's planned 7 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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