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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
BehavioralSleepQ 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).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: SleepQ Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)Experimental treatment 1 intervention
Group B: Care-as-Usual (CAU)No intervention 0 interventions
Trial outcomes
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.
Time frame
From baseline to 12 weeks after enrollmentSecondary outcomes
1
Change in Patient Health Questionnaire-9 (PHQ-9) Score from Baseline to Week 12
The PHQ-9 is a 9-item validated self-report measure of depressive symptoms. Each item is scored from 0 to 3, producing a total score from 0 to 27, with higher scores indicating more severe depression. The outcome is the change in total PHQ-9 score from baseline to week 12.
Time frame
From baseline to week 122
Change in Generalized Anxiety Disorder-7 (GAD-7) Score from Baseline to Week 12
The GAD-7 is a 7-item validated self-report measure of anxiety symptoms. Each item is scored from 0 to 3, yielding a total score from 0 to 21, with higher scores indicating more severe anxiety. The outcome is the change in total GAD-7 score from baseline to week 12.
Time frame
From baseline to week 123
Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) Score from Baseline to Week 12
The DBAS-16 is a 16-item self-report scale assessing maladaptive sleep-related beliefs. Items are rated from 0 (strongly disagree) to 10 (strongly agree). The total score is the mean of all items and ranges from 0 to 10, with higher scores indicating stronger dysfunctional beliefs. The outcome is the change in mean DBAS-16 score from baseline to week 12.
Time frame
From baseline to week 124
Change in Work and Social Adjustment Scale (WSAS) Score from Baseline to Week 12
The WSAS is a 5-item self-report measure assessing functional impairment across work, home management, social activities, and relationships. Each item is scored from 0 (no impairment) to 8 (severe impairment), producing a total score from 0 to 40. Higher scores indicate greater functional impairment. The outcome is the change in total WSAS score from baseline to week 12.
Time frame
From baseline to week 12Other outcomes
1
Change in Patient Satisfaction With the SleepQ App From Intervention Start to Week 12
Patient satisfaction with the SleepQ digital intervention will be assessed in the intervention group using a validated satisfaction quesitonnaire based on the Second Ordinance Amending the Digital Health Applications Ordinance (BfArM, 2025) The questionnaire includes five items rated on a 0-10 Likert-type scale: 1. I was able to easily understand the DiGA. 2. The DiGA functioned reliably. 3. When I had questions, I received support easily and without complications. 4. The DiGA helped me understand my condition better than before. 5. How likely is it that you would recommend this DiGA to friends and family? For Items 1-4, higher scores indicate stronger agreement (0 = does not apply at all; 10 = extremely likely). For Item 5, higher scores indicate greater likelihood of recommendation (0 = extremely unlikely; 10 = extremely likely). Scores will be analyzed as change from intervention start.
Time frame
From intervention start (code activation) to week 12 Source ClinicalTrials.gov
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