WELT-REST: WELT Randomized Evaluation of Sleep Therapy
ConditionInsomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWELT corp
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov