Trial document




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  DRKS00005990

Trial Description

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Title

Online-Based Stress-Management Taining - also effective under unfavourable working conditions? Randomized Controlled Trial

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Trial Acronym

GET-ON-Stress unfavourable working conditions

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URL of the Trial

https://geton-training.de/stressbewaeltigung.php

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Brief Summary in Lay Language

According to the World Health Organization, stress is one of the major health risks of the 21st century. Occupational stress constitutes a risk factor for a variety of psychological and physical disorders. In general, stress is associated with unfavourable health behaviours and leads to loss of productivity at work and affects private life. GET-ON-Stress, a flexible Internet training for managing work-related stress, aims to reduce perceived stress and depressive symptomes. It targets employees who are seeking help for coping with personal problems and are under unfavourable work conditions in terms of high job demands as well as low gratification at work. The program can support participants in recognizing their personal stressors, choosing effective coping strategies and strengthening their abilities to solve personal and work-related problems in a systematic and effective manner. The goal of the study is to evaluate the efficacy of the online training under unfavourable work conditions on the part of employees. Feedback on demand will be provided.
Participants will be randomly allocated into either the intervention or the waitlist control group.

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Brief Summary in Scientific Language

Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees. However, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems, yet the evidence in this field is scarce. The aim of this study is the examination of the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees under unfavourable work conditions. Participants (N=264) experiencing effort-reward imbalance (score > 0.715) will be randomly allocated into either the intervention or the waitlist control group. Participants of the intervention group gain access to the seven session intervention immediately, the waitlist control group receives the intervention six months later. The intervention is based on poblem- and emotion-focused stress management according to Lazaus and contains systematic poblem solving as well as effective emotion regulation strategies. Participants will receive feedback on demand. Data are collected at baseline, at seven weeks and six months post randomization. Perceived stress is measured as a primary outcome. Secondary outcomes include symptoms of depression and emotional exhaustion amongst others. Furthermore, a cost-effectiveness analysis will be conducted.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005990
  •   2014/12/16
  •   [---]*
  •   yes
  •   Approved
  •   Ebert201408_Stresstraining, Ethikbeirat der Leuphana Universität Lüneburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   job-related stress
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Interventions/Observational Groups

  •   Intervention group: The intervention consists of 7 sessions. Each session will be completed in approximately 45-60 minutes. Four weeks after completing the training, an optional booster session is provided. Participants receive feedback on demand by an online coach. Assessments will be scheduled at pretest, posttest (7 weeks after randomization) and 6 months after randomization.
  •   Waitlist control group: Participants obtain access to the same training as participants of the intervention group after a waiting period of 6 months. Assessments will be scheduled at pretest, posttest (7 weeks after randomization) and 6 months after randomization.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Perceived stress measured with the Perceived Stress Scale (PSS-10, Cohen, 1983) at baseline, after completing the training (7 weeks after randomization) and at 6-months-follow-up (6 months after randomization, 6-M-FU)

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Secondary Outcome

• Demographic Variables Questionnaire (pre)
• Emotional exhaustion (Maslach Burnout Inventory, MBI-GS-D, emotional exhaustion scale, Maslach & Jackson, 1981): prä, post (7 weeks), 6-M-FU
• Depressive symptoms (CES-D, Hautzinger & Bailer, 1993): pre, post, 6-M-FU
• Self-assessed emotional competences (SEK-27, Berking & Znoj, 2008): pre
• Effort-Reward Imbalance Scale, short version (ERI-S, Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009): pre, post, 6-M-FU
• Dimensions of personality (Big Five Inventory, BFI-10, Rammstedt & John, 2007): pre
• Current occupation (self-developed): pre
• Work engagement (Utrecht Work Engagement Scale, UWES, Schaufeli, Salanova, González-Romá, & Bakker, 2002): pre, post, 6-M-FU
• Assessment of Quality of Life (AQoL, Richardson, Iezzi, Khan, & Maxwell, 2014): measurement of health-related quality of life (pre, 6-M-FU)
• Quality of life for economic evaluation (EuroQol, Graf, Claes, Greiner, & Uber): pre, post, 6-M-FU
• Cost related to mental and physical impairment (German adaption of Trimbos / iMTA questionnaire for Costs associated with Psychiatric Illness, TiC-P, Van Roijen Hakkaart, 2002): pre, post, 6-M-FU
• Volitional competences (Short Form of the Volitional Components Questionnaire, SSI-36, Forstmeier & Rüddel, 2008; subscales of attentional focusing, self-motivation, goal recollection, forgetfulness prevention, impulse control and initiation control): pre
• Self-efficacy (SWE, Schwarzer & Jerusalem, 1999): pre
• Self-Regulation Scale (SRQ, Schwarzer, 1999): prä
• Self-Control Scale (SCS-K-D. Bertrams & Dickhäuser, 2009): pre
• Therapy motivation questionnaire (FPTM-23, Schulz, Lang, Nübling, & Koch, 2003): pre
• Task-related motivational and volitional factors in line with the Health Action Process Approach (HAPA, according to guidelines by Schwarzer et al., 2003): pre
• Internet Affinity Scale (Papacharissi & Rubin, 2000), measuring internet affinity (pre)
• Work Limitations Questionnaire (WLQ-8, Lerner, Amick, Rogers, Malspeis, Bungay, & Cynn, 2001), measuring the on-the-job impact of chronic health problems (pre, post)
• Occupational Self-Efficacy Scale, short version (Rigotti, Schyns, Mohr, 2008): pre, post
• Connor-Davidson Resilience Scale (CD-RISK, Campbell-Sills & Stein, 2007), measuring the abil- ity to cope with adversity (pre, post)
• Segmentation Supplies (Kreiner, 2006): pre
• Training satisfaction: self-development based on participants´satisfaction questionnaire (ZUF 8, Schmidt, Lamprecht, Wittmann, 1989) and the Client Satisfaction Questionnaire (CSQ, Attkisson & Zwick, 1982): post
• Dropout reasons (self-development): post
• Assessment of occupation, work loss and productivity loss (subscale of the German adaption of Trimbos / iMTA questionnaire for Costs associated with Psychiatric Illness, TiC-P, Van Roijen Hakkaart, 2002) (post)
• Questionnaire on willingness to pay (self-developed): post
• Preference for Training Questionnaire (self-developed): post
• Use of other support services questionnaire (self-development): post, 6-M-FU





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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/12/17
  •   264
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Effort-Reward Imbalance (score > 0.715 = inclusion; Sigrist, Li, Montano, 2014; Lehr, Koch, Hillert, 2009) • employed • internet access • valid e-mail-address

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Exclusion Criteria

• at baseline slightly suicidal (BDI II item 9 [> 1]) • not willing to sign informed consent • diagnosed psychosis or dissociative symptoms in the past

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Addresses

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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  Dr.  David  Ebert 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Barmer GEK 
    • Lichtscheider Str. 89
    • 42285  Wuppertal
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Ms.  Dipl.-Psych.  Anna-Carlotta  Zarski 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Ms.  Dipl.-Psych.  Anna-Carlotta  Zarski 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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Sources of Monetary or Material Support

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    • Barmer GEK
    • Lichtscheider Str. 89
    • 42285  Wuppertal
    • Germany
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    • Investitions-und Förderungsbank Niedersachsen (NBank)
    • Günther-Wagner-Allee 12-16
    • 30177  Hannover
    • Germany
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    • European Union (finanzielle Förderung organisiert über NBank bzw. Niedersächsisches Ministerium für Wirtschaft, Arbeit und Verkehr)
    • Friedrichwall 1
    • 30159  Hannover
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Heber et al.: Efficacy and cost-effectiveness of a web-based and mobile stress management intervention for employees: design of a randomized controlled trial. BMC Public Health 2013 13:655.
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* This entry means the parameter is not applicable or has not been set.