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NOT YET RECRUITING

NCT07289217

WELT-REST: WELT Randomized Evaluation of Sleep Therapy

Sponsor: WELT corp

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12

Completion Date

2026-07

Last Updated

2025-12-17

Healthy Volunteers

Conditions

Insomnia

Interventions

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).

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

Locations (1)

Berlin Medical Association (Ärztekammer Berlin)

Berlin, Germany