InsomniaWELT-RESTNCT07289217
WELT-REST: WELT Randomized Evaluation of Sleep Therapy
A study testing SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in people with Insomnia, run by WELT corp at 1 site in Germany.
Trial summary
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: Does adding the SleepQ app to care as usual (CAU) improve insomnia symptoms after 12 weeks? Does SleepQ also improve depressive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥18 years old
- Confirmed current diagnosis of F51.0 Nonorganic insomnia or G47.0 Sleep disorders
- Possession of a mobile device with internet connection (must be run on iOS software, minimum version 18) with internet connection
- Sufficient German language proficiency required for the correct use of the intervention and the mobile device
- Personal e-mail address for registration
- Willing and able to provide written informed consent
- Insomnia Severity Index (ISI) socre of 15 or higher, indicating clinically relevant symptoms of insomnia
- Registered with a GP, sleep specialist or other health care professional
Who cannot join
- Use of a digital interventioan for insomnia treatment in the past 6 months or planned use of comparable digital intervention during the study period
- PHQ-9 score at screening ≥ 20 and/or item 9 f PHQ-9 ≥ 1
- GAD-7 score at screening ≥ 15
- Intermittent use and/or recent initiation (< 3m) or planned use of insomnia specific prescription-only pharmacological therapy
- Intermittent use and/or recent initiation (< 3m) or planned use of a psychotropic during the study period which has recognised potential effects on insomnia
- Participation in CBT or other psychotherapy to treat sleep disorders in the last 6 months (outpatient, inpatient) or planned start during the study period
Show all 16Show fewer
- Known history or diagnosis of substance or alchol abuse or dependence within 12 months prior to screening (diagnosis of F10-F19, excluding F17.1 and F17.2)
- Current or planned participation in other clinical trials during the study period
- Working in shifts
- Currently pregnant or planning to become pregnant within the next 3 months
- 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)
- Diagnosis of epilepsy
- Presence of 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)
- 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.
- Acute suicidal thoughts or intentions within the past 12 months
- Presence of obstructive sleep apnea, restless legs syndrome, parasomnia, and other sleep behavior problem
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Berlin Medical Association (Ärztekammer Berlin)
Berlin, 10969
Ethics Committee of the Berlin Medical Association, +49 30 408 06 - 0, ek@aekb.de
About this study
Official title: A Randomized Controlled Decentralized Clinical Pilot Trial to Assess the Effectiveness and Sagety of the Digital Cognitive Behavioral Therapy Intervention SleepQ for Insomnia
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:
- Does adding the SleepQ app to care as usual (CAU) improve insomnia symptoms after 12 weeks?
- Does SleepQ also improve depressive symptoms, anxiety, beliefs about sleep and daily functioning?
Read more
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.
Read the detailed description
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.
- Conditions
- Insomnia
- Being tested
- SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
- Keywords
- dCBT - I, CBT - I, Insomnia, Cognitive Behavioral Therapy, Sleep Disorder, Digital Therapeutics, Digital CBT - I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) | Experimental | Not described Receives: Behavioral: SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) |
| Care-as-Usual (CAU) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 12 weeks after enrollment
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WELT corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289217
- Sponsor's protocol ID
- WCTP-DI-A-01
- Acronym
- WELT-REST
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Decentralized Clinical Pilot Trial to Assess the Effectiveness and Sagety of the Digital Cognitive Behavioral Therapy Intervention SleepQ for Insomnia
- ClinicalTrials.gov ID
- NCT07289217
- Acronym / sponsor ID
- WELT-REST / WCTP-DI-A-01
- Conditions
- Insomnia
- Keywords
- dCBT - I, CBT - I, Insomnia, Cognitive Behavioral Therapy, Sleep Disorder, Digital Therapeutics, Digital CBT - I
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- WELT corpIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does adding the SleepQ app to care as usual (CAU) improve insomnia symptoms after 12 weeks?
- Does SleepQ also improve depressive symptoms, anxiety, beliefs about sleep and daily functioning?
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) | Experimental | Behavioral: SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) |
| Care-as-Usual (CAU) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients ≥18 years old
- Confirmed current diagnosis of F51.0 Nonorganic insomnia or G47.0 Sleep disorders
- Possession of a mobile device with internet connection (must be run on iOS software, minimum version 18) with internet connection
- Sufficient German language proficiency required for the correct use of the intervention and the mobile device
- Personal e-mail address for registration
Key exclusion criteria (16 listed)
- Use of a digital interventioan for insomnia treatment in the past 6 months or planned use of comparable digital intervention during the study period
- PHQ-9 score at screening ≥ 20 and/or item 9 f PHQ-9 ≥ 1
- GAD-7 score at screening ≥ 15
- Intermittent use and/or recent initiation (< 3m) or planned use of insomnia specific prescription-only pharmacological therapy
- Intermittent use and/or recent initiation (< 3m) or planned use of a psychotropic during the study period which has recognised potential effects on insomnia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) |
Primary outcome
Change in Insomnia Severity Index (ISI) Score from Baseline to Week 12
Time frame: From baseline to 12 weeks after enrollment
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.
5 secondary outcomes
Change in Patient Health Questionnaire-9 (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
Time frame: From baseline to week 12
Change in Dysfunctional Beliefs and Attitudes about Sleep (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
Time frame: From baseline to week 12
Change in EuroQol Visual Analog Scale (EQ-VAS) Score from Baseline to Week 12
Time frame: From baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in people with Insomnia, run by WELT corp at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yujin Lee (+82-2-6439-0707, info@weltcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) Score from Baseline to Week 12 (time frame: From baseline to 12 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.