WELT-REST: WELT Randomized Evaluation of Sleep Therapy

NCT07289217 | Not Yet Recruiting

• 1 other identifier: WCTP-DI-A-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Insomnia

Keywords

dCBT - I; CBT - I; Insomnia; Cognitive Behavioral Therapy; Sleep Disorder; Digital Therapeutics; Digital CBT - I

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in Patient Health Questionnaire-9 (PHQ-9) Score from Baseline to Week 12

  From baseline to week 12

• Change in Generalized Anxiety Disorder-7 (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

  From baseline to week 12

• Change in Work and Social Adjustment Scale (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

  From baseline to week 12

Other Outcomes (1)

• Change in Patient Satisfaction With the SleepQ App From Intervention Start to Week 12

  From intervention start (code activation) to week 12

Study Arms (2)

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

Interventions

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).

SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• WELT corp: lead

Study Sites (1)

Berlin Medical Association (Ärztekammer Berlin)

Berlin, 10969, Germany

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yujin Lee

CONTACT

+82-2-6439-0707; info@weltcorp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

DE (1)