Trial document




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  DRKS00004749

Trial Description

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Title

Internet-based occupational stress management program

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Trial Acronym

GET.ON Stress

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URL of the Trial

https://www.geton-training.de/stressbewaltung.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. The „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 dealing with difficult emotions. The aim of the study is to evaluate the efficacy of the online training, which 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. Furthermore, it aims to improve their way of dealing with stress and difficult emotions in occupational and private life.

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Brief Summary in Scientific Language

Work-related stress is associated with a variety of mental and emotional problems, such as symptoms of depression, anxiety, and sleep disturbances. This can lead to substantial economic costs due to loss of productivity, absenteeism or inability to work. There is a considerable amount of evidence on traditional face-to-face stress management interventions; however, they are costly, time-consuming and only available for a certain number of people. The aim of the study is to assess the efficacy and cost-effectiveness of an internet-based stress management program to reduce perceived stress in adult employees. Participants (N=264) experiencing high levels of stress (Perceived Stress Scale ≥ 22) will be randomly allocated into either the intervention group which gains access to the seven session intervention immediately or a waitlist control group which 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 personal feedback on every session from an online coach and will be supported through mobile components in their daily life. Data are collected at baseline, at seven weeks and six months post randomization. An extended follow up at 12 months will be carried out for the intervention group. Perceived stress is measured as a primary outcome. Secondary outcomes include symptoms of depression, anxiety and emotional exhaustion amongst others. Furthermore, a cost-effectiveness analysis will be conducted.

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Organizational Data

  •   DRKS00004749
  •   2013/02/21
  •   [---]*
  •   yes
  •   Approved
  •   AZ 2012-43K, Marburg- Ethikkommission des Fachbereichs Psychologie der Philipps Universität Marburg URL: http://www.uni-marburg.de/fb04/gremien/folder.2010-10-20.3891275312
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Secondary IDs

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

  •   work-related stress
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Interventions/Observational Groups

  •   Intervention group: Online training consisting of 7 sessions. Each session will be completed in approximately 45-60 minutes. Participants receive feedback via e-mail from an online coach. Four weeks after finishing the training, participants complete an additional booster session. Questionnaires are asked to be completed at pre- and posttest (7 weeks), as well as at 6 and 12 months follow up.
  •   Waitlist control group: Participants obtain access to the same training as participants of the intervention group. They do not receive feedback to every single session of the training; however, can address questions to an online coach. Questionnaires are asked to be completed at pre- and posttest as well as at 6 months follow up.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   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 the training (7 weeks) and at 6-, and 12-month follow-up (only intervention group).

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Secondary Outcome

- Emotional Exhaustion (Maslach Burnout Inventory- Emotional Exhaustion Scale): pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up;
- Symptoms of anxiety (Hospital Anxiety and Depression Scale, HADS, Subscale Anxiety): pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up;
- Depressive Symptoms (CES-D): pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up
- Self-reported Emotional Competencies (SEK-27 - Subscales: Acceptance, comprehension, and self support): pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up;
- Self-reported Emotional Competencies - Emotional Specific Version (SEK-ES), subscale stress and tension: pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up;
- Insomnia Severity (Insomnia Severity Index, ISI): pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up;
- Worrying (Penn State Worry Questionnaire, Ultra Short Version): pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up;
- Mental detachment (Recovery Experience Questionnaire – Subscale Mental Detachment): pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up;
- Work-related stress (Effort Reward Imbalance, ERI-S): pre-treatment;
- Measurement of Online-Training Expectancy (confidence): pre-treatment
- Work engagement (Utrecht Work Engagement Scale, UWES): pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up;
- Attitudes toward psychological help: pre-treatment, post-treatment (7 weeks), 6- and 12-month follow-up;
- Costs that are associated with stress (German adaptation of the Trimbos/iMTA questionnaire for costs associated with psychiatric illness,TiC-P): pre, 6- and 12-month follow-up;
- Quality of life (SF-12 and EuroQol): pre, 6- and 12-month follow-up;
- Reasons for dropout: post-treatment;
- Training satisfaction (German adaptation of the ZUF 8, a German version of the Client Satisfaction Questionnaire, CSQ): post-treatment;
- Negative Effects of Online-Trainings (adaptation of the German inventory for the assessment of negative side effects of psychotherapy, INEP): post, 6- and 12-month follow-up

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   2013/03/01
  •   Actual
  •   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

Distinct level of perceived stress (Perceived Stress Scale [PSS-10] ≥ 22), access to the internet, valid email-address, employed

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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 Daniel  Ebert (Ansprechpartner des Sponsors) 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Ms.  Elena  Heber 
    • Rotenbleicherweg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Ms.  Dipl.-Psych.  Elena  Heber 
    • Rotenbleicherweg 67
    • 21335  Lüneburg
    • Germany
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Sources of Monetary or Material Support

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    • Investitions-und Förderungsbank Niedersachsen (NBank)
    • Günther-Wagner-Allee 12-16
    • 30177  Hannover
    • Germany
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    • European Union
    • 1000  Brüssel
    • Belgium
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Status

  •   Recruiting ongoing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.