WELT-REST: WELT Randomized Evaluation of Sleep Therapy

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?

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Presence of obstructive sleep apnea, restless legs syndrome, parasomnia, and other sleep behavior problem