Condition category
Nervous System Diseases
Date applied
05/04/2019
Date assigned
08/04/2019
Last edited
08/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
German-speaking adults

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 March 2020

Who is funding the study?
There is no external funding for the study

Who is the main contact?
Dr Ina Beintner
ina.beintner@tu-dresden.de

Trial website

https://tu-dresden.de/mn/psychologie/ikpp/e-mental-health/forschung/refresh

Contact information

Type

Public

Primary contact

Dr Ina Beintner

ORCID ID

Contact details

Institute for Clinical Psychology and Psychotherapy
Chemnitzer Straße 46
Dresden
01187
Germany
+49 (0)351 463 37460
ina.beintner@tu-dresden.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Refresh - Does an app based short intervention improve quality of sleep? A randomised controlled feasibility study

Acronym

REFRESH

Study hypothesis

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.

Ethics approval

Approved 29/03/2019, Ethikkommission (IRB) an der TU Dresden (Fetscherstraße 74, 01307 Dresden, Germany; Tel: +49 (0)351 458 2992; Email: ethikkommission@mailbox.tu-dresden.de), ref: EK 111032019

Study design

Single-center unblinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

Not available in English

Condition

Poor sleep quality

Intervention

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).

Intervention type

Behavioural

Phase

Drug names

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

01/03/2019

Overall trial end date

31/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 18 years of age
2. Fluent in German
3. Access to the Internet during the intervention period

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

586

Participant exclusion criteria

1. Current treatment for depression
2. History of psychotic or bipolar disorder
3. Suicidal ideation

Recruitment start date

15/04/2019

Recruitment end date

30/09/2019

Locations

Countries of recruitment

Austria, Germany, Luxembourg, Switzerland

Trial participating centre

Technische Universität Dresden, Institute for Clinical Psychology and Psychotherapy
Chemnitzer Straße 46
Dresden
01187
Germany

Sponsor information

Organisation

Technical University Dresden (Technische Universität Dresden)

Sponsor details

Institut für Klinische Psychologie und Psychotherapie
Chemnitzer Str. 46
Dresden
01187
Germany
0351-463-0
ina.beintner@tu-dresden.de

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

31/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/04/2019: Trial's existence confirmed by ethics committee.