Does an app based short intervention improve quality of sleep?
| ISRCTN | ISRCTN53553517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53553517 |
| Secondary identifying numbers | 1 |
- Submission date
- 05/04/2019
- Registration date
- 08/04/2019
- Last edited
- 24/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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 October 2020
Who is funding the study?
There is no external funding for the study
Who is the main contact?
Bianka Vollert
bianka.vollert@tu-dresden.de
(updated 03/07/2019, previously: Dr Ina Beintner
ina.beintner@tu-dresden.de)
Contact information
Public
Institute for Clinical Psychology and Psychotherapy
Chemnitzer Straße 46
Dresden
01187
Germany
| Phone | +49 (0)351 463 38570 |
|---|---|
| bianka.vollert@tu-dresden.de |
Study information
| Study design | Single-center unblinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in English |
| Scientific title | Refresh - Does an app based short intervention improve quality of sleep? A randomised controlled feasibility study |
| Study acronym | REFRESH |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2019 |
| Completion date | 31/10/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 586 |
| Total final enrolment | 371 |
| Key inclusion criteria | 1. Over 18 years of age 2. Fluent in German 3. Access to the Internet during the intervention period |
| Key exclusion criteria | 1. Current treatment for depression 2. History of psychotic or bipolar disorder 3. Suicidal ideation |
| Date of first enrolment | 15/04/2019 |
| Date of final enrolment | 31/03/2020 |
Locations
Countries of recruitment
- Austria
- Germany
- Luxembourg
- Switzerland
Study participating centre
Dresden
01187
Germany
Sponsor information
University/education
Institut für Klinische Psychologie und Psychotherapie
Chemnitzer Str. 46
Dresden
01187
Germany
| Phone | +49(0)351-463-0 |
|---|---|
| bianka.vollert@tu-dresden.de | |
"ROR" |
https://ror.org/042aqky30 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of results in a high-impact peer reviewed journal. No additional documents will be publicly available. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | outcome measure results | 21/03/2023 | 24/03/2023 | Yes | No |
Editorial Notes
24/03/2023: Publication reference added.
20/08/2020: Internal review.
03/04/2020: The total final enrolment was added.
01/04/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 31/03/2020.
2. The overall trial end date has been changed from 30/06/2020 to 31/10/2020.
3. The plain English summary has been updated to reflect the changes above.
08/10/2019: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2020 to 30/06/2020.
2. The recruitment end date was changed from 30/09/2019 to 31/12/2019.
03/07/2019: The following changes were made to the trial record:
1. The public contact was changed from Dr. Ina Beintner <Ina.Beintner@tu-dresden.de> to Bianka Vollert <bianka.vollert@tu-dresden.de>.
2. The sponsor email address was changed from Dr. Ina Beintner <Ina.Beintner@tu-dresden.de> to Bianka Vollert <bianka.vollert@tu-dresden.de>.
3. The plain English summary was updated to reflect these changes.
08/04/2019: Trial's existence confirmed by ethics committee.
