Plain English Summary
Background and study aims
Two out of three adults in Germany have trouble sleeping at least occasionally, among employees the numbers rise up to 80%. Poor sleep quality can result in daytime fatigue and reduce performance, and is also associated with irritability and depressed mood. Only a few people with poor sleep quality seek professional help. Therefore, researchers have developed an app-based training to help people implement behaviour changes and improve sleep quality. The aim of this study is to find out whether this training helps improve sleep.
Who can participate?
What does the study involve?
Participants are randomly allocated to either receive access to the app-based training immediately or to wait for 6 months. The training is self-paced, but the recommended duration is 8 weeks (1 chapter per week). There are three assessments (start of the study, 8 weeks, 26 weeks).
What are the possible benefits and risks of participating?
Participants may improve their sleep quality. For some participants, thinking about their thoughts and feelings may be upsetting.
Where is the study run from?
Technische Universität Dresden, Institute of Clinical Psychology and Psychotherapy (Germany)
When is the study starting and how long is it expected to run for?
March 2019 to October 2020
Who is funding the study?
There is no external funding for the study
Who is the main contact?
(updated 03/07/2019, previously: Dr Ina Beintner
Ms Bianka Vollert
Institute for Clinical Psychology and Psychotherapy
Chemnitzer Straße 46
+49 (0)351 463 38570
Refresh - Does an app based short intervention improve quality of sleep? A randomised controlled feasibility study
The current study seeks to examine the acceptability and efficacy of an app-based short intervention (Refresh) to improve sleep quality compared to a waitlist control group in the general population. The hypothesis is that Refresh will be efficacious, with significant improvements of sleep quality within the intervention group and differences at post intervention and follow-up between the intervention group and the waitlist control group.
Approved 29/03/2019, Ethikkommission (IRB) an der TU Dresden (Fetscherstraße 74, 01307 Dresden, Germany; Tel: +49 (0)351 458 2992; Email: firstname.lastname@example.org), ref: EK 111032019
Single-center unblinded randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in English
Poor sleep quality
Method of randomisation: stratified block randomization (strata: gender, sleep quality (RIS total score <12 vs >=12), use of sleep medication).
1. Refresh: an app-based short intervention to improve sleep quality
2. Waitlist control
The intervention is self-paced, but the recommended duration is 8 weeks (1 chapter per week). There are three assessments (baseline, post-intervention (+8 weeks), follow-up (+26 weeks).
Primary outcome measure
Sleep quality is measured using the Regensburg Insomnia Scale (RIS) Total Score at baseline and post-Intervention (8 weeks)
Secondary outcome measures
1. Sleep quality is measured using the Regensburg Insomnia Scale Total Score at baseline and follow-up (26 weeks)
2. Depression symptoms are measured using the depression scale from the Patient Health Questionnaire (PHQ-9 ) Total Score at baseline, post intervention (8 weeks) and follow-up (26 weeks)
3. Acceptance of the training is measured using the Working Alliance Scale adapted for Online Interventions at Post Intervention (8 weeks) and usage of the intervention (during intervention period)
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Over 18 years of age
2. Fluent in German
3. Access to the Internet during the intervention period
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Current treatment for depression
2. History of psychotic or bipolar disorder
3. Suicidal ideation
Recruitment start date
Recruitment end date
Countries of recruitment
Austria, Germany, Luxembourg, Switzerland
Trial participating centre
Technische Universität Dresden, Institute for Clinical Psychology and Psychotherapy
Chemnitzer Straße 46
Technical University Dresden (Technische Universität Dresden)
Institut für Klinische Psychologie und Psychotherapie
Chemnitzer Str. 46
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication of results in a high-impact peer reviewed journal. No additional documents will be publicly available.
IPD sharing statement
After the main results of the study have been published, anonymised participant level data can be shared for individual patient data meta-analyses upon request to Dr Ina Beintner (Ina.Beintner@tu-dresden.de), stating the purpose and methods of the planned project. ICMJE authorship recommendations apply. Participants give consent that their anonymised data can be used in research cooperation projects.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)