Online self help for better sleep in teachers with high occupational strain

Organizational Data

DRKS-ID:
DRKS00004984
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2013-05-16
Last update in DRKS:
2019-03-13
Registration type:
Prospective

Acronym/abbreviation of the study

No Entry

URL of the study

http://www.geton-training.de/Regeneration.php

Brief summary in lay language

The recovery training is for teachers, who have sleep problems and problems with mentally detaching from work. After stress at work we mentally and physically seek for recovery. Especially for teachers, who experience rather loose boundaries between work and private life, successful recovery is very important. Some stress factors are even inevitable. Esspecially then, phases of successful recovery are very important to prevent chronic stress reactions. Chronic stress reactions are developed, when it is repeatedly not possible to establish recovery. Recovery means: a)mental detachment from work, because worrying and rumination about problems at work can lead to the same strain as work itself. b) recovery activities, that are important to promote mental detachment (to "switch off") and c) restaurative sleep. This is the most important element of recovery. Occupational stress and esspecially corresponding rumination and worrying lead to increased strain and tension, which is one cause for sleep disorders. 10 % of the population suffer from problems falling asleep, sleeping through or waking to early in the morning. The aim of the present study is to evaluate an online self help training, that is specifically designed to help teachers find restaurative sleep and to mentally detach from work. For this evaluation, participants are randomly allocated into one of two groups: One half gets immediate access to the training, the other half following a waiting period of 8 weeks.

Brief summary in scientific language

Insomnia and work-related stress often co-occur. Both are associated with personal distress and diminished general functioning, as well as substantial socio-economic costs. Internet-based CBT-I interventions (ICBT-I) could potentially reduce the given supply gap and are proven to be effective. There is less known about the efficacy of ICBT-I in populations affected by work-related stress. Thus, the aim of the present study is to evaluate an ICBT-I training tailored to teachers affected by occupational stress. In a two-arm randomized controlled trial (N = 128), the effects of a self help ICBT-I training ("GET.ON Recovery") will be compared to a waitlist-control condition pre-treatment and post-treatment. German teachers with clinical significant insomnia complaints and work-related strain are included. Apart from classic CBT-I elements (e.g. sleep hygiene, sleep restriction) GET.ON Recovery accentuates the promotion of recreational activities and cognitive detachment. The primary outcome is insomnia severity.

Health condition or problem studied

ICD10:
F51.0 - Nonorganic insomnia
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
• Arm 1: six week online training (pure self-help). Training consists of 6 modules, each taking circa 1 h to work through. During the traning, the primary study investigator is available in case problems or questions occur. Half of the total sample (N=128, n = 64) is randomised in Arm 1. this group gets "GET.ON Recovery", a sleep training based on Cognitive Behavioral Therapy, that is specifically designed for teachers with occupational strain. This training aims to reduce insomnia severity, measured by the Insomnia Severity Index (ISI). Insomnia Severity as well as secondary outcomes like rumination or depressive symptoms will be measured pre-treatment and post-treatment (8 weeks)
Arm 2:
• Arm 2: waitlist-control-grouo (receives online-training without supporting e-mails following the 6-months follow-up). Before Arm 1 gets access to the online training (GET.ON Recovery), both groups, Arm 1 and Arm 2,fill in the Baseline questionnaires (online). After Arm 1 worked through the online training (8 weeks), Arm 1 and Arm 2 fill in the post-questionnaires (online). The questionnaires assess insomnia severity, rumination, depressive symptoms, etc. After that last assessment, 8 weeks after randomization, Arm 2 receives access to GET.ON Recovery (self-help). During the traning, the primary study investigator is available in case problems or questions occur.

Endpoints

Primary outcome:
Insomnia Severity, measured with the Insomnia Severity Index (ISI; Morin, 2011) at Baseline and after the training (8 weeks)
Secondary outcome:
depressive Symptoms (CES-D): pre-treatment, post-treatment (8 weeks); worrying (Penn State Worry Questionnaire, PSWQ): pre, post; - psychological strain in the work context (Irritation Scale, IS): pre, post; sleep effort (Glasgow Sleep Effort Scale): pre, post (8 weeks); - restorativeness of the sleep(Schlaffragebogen B): pre, post; subjective quality of sleep (one item of the Pittsburgh Sleep Quality Index, PSQI): pre, post; recovery experience (Recovery Experience Questionnaire): pre, post; frequency of recovery activities (Recreation experience and activity questionnaire, ReaQ): pre, post; Health-Related Quality of Life (Short Form SF-12 Health Survey Questionnaire): pre, post; costs associated with nonorganic insomnia (for cost-effectiveness analyses) (German adaptation of the Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TiC-P)): pre, post; work-related stress (Effort Reward Imbalance, short version, ERI-S): pre satisfaction with the online training (german adaptation of the ZUF 8, which is the german version of the Client Satisfaction Questionnaire, CSQ): post

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
No Entry

Recruitment period and number of participants

Planned study start date:
2013-05-20
Actual study start date:
2013-05-16
Planned study completion date:
No Entry
Actual Study Completion Date:
2014-11-24
Target Sample Size:
128
Final Sample Size:
128

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
clinic significant insomnia complaints (Insomnia Severity Indey≥15); - occupational strain/problems with mentally detaching from work (irritation scale, subscale "cognitive Irritation" ≥15); - currently employed/in work as a teacher; - access to the internet; - valid e-mail address

Exclusion Criteria

at Baseline slightly suicidal (BDI II item 9 >1); - currently in psychotherapy or in a waitlist for psychotherapy; not willing to sign informed consent

Addresses

Primary Sponsor

Address:
Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
Dr. Dirk Lehr
Rotenbleicher Weg 67
21335 Lüneburg
Germany
Telephone:
041316777637
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.leuphana.de/inkubator
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
Hanne Thiart
Rotenbleicher Weg 67
21335 Lüneburg
Germany
Telephone:
04131 677 7637
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.leuphana.de/inkubator

Contact for Public Queries

Address:
Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
Hanne Thiart
Rotenbleicher Weg 67
21335 Lüneburg
Germany
Telephone:
04131 677 7637
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.leuphana.de/inkubator

Principal Investigator

Address:
Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
Hanne Thiart
Rotenbleicher Weg 67
21335 Lüneburg
Germany
Telephone:
04131 677 7637
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.leuphana.de/inkubator

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
European Union (finanzielle Förderung organisiert über NBank bzw. Niedersächsisches Ministerium für Wirtschaft, Arbeit und Verkehr Friedrichswall 1 30159 Hannover)
Günther-Wagner-Allee 12-16
30177 30177 Hannover
Germany
Telephone:
0511 300310
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.nbank.de

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Unfallkasse NRW
Sankt-Franziskus-Str. 146
40470 Düsseldorf
Germany
Telephone:
0211 90240
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Ethik-Kommission des Fachbereichs Psychologie an der Philipps-Universität Marburg [Marburg- Ethikkommission des Fachbereichs Psychologie der Philipps Universität Marburg]
Prof. Dr. Martin Pinquart
Gutenbergstr 18
35032 Marburg
Germany
Telephone:
065212823638
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://uni-marburg.de/fb04/gremien/folder.2010-10-20.3891275312

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2013-04-17
Ethics committee number:
2013-10-K
Vote of the Ethics Committee:
Approved
Date of the vote:
2013-04-25

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Ebert et al. (2015). Restoring depleted resources: Efficacy and mechanisms of change of an internet-based unguided recovery training for better sleep and psychological detachment from work. Health Psychology, Vol. 34, Supplement, 1240–1251
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry