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WELT-REST: WELT Randomized Evaluation of Sleep Therapy

NCT07289217 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-17

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • WELT corp

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07289217 on ClinicalTrials.gov