Trial document




drksid header

  DRKS00005384

Trial Description

start of 1:1-Block title

Title

Online self-help training for work-related stress

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

GET.ON Stress self-help

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

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

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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 self-help 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 be supported through mobile components (text message coach) in their daily life. 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, anxiety and emotional exhaustion amongst others. Furthermore, a cost-effectiveness analysis will be conducted.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005384
  •   2013/11/05
  •   [---]*
  •   yes
  •   Approved
  •   AZ 2013-35K, Ethik-Kommission des Fachbereichs Psychologie der Philipps-Universität Marburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Work-related stress
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention group: Online training consisting of 7 sessions. Each session will be completed in approximately 45-60 minutes. 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 months follow up.
  •   Waitlist control group: After 6 months, participants obtain access to the same training as participants of the intervention group. Questionnaires are asked to be completed at pre- and posttest as well as at 6 months follow up.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Perceived Stress, measured with the Perceived Stress Scale (PSS-10; Cohen, 1983) at Baseline, after the training (7 weeks) and at 6-months follow-up

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Emotional Exhaustion (Maslach Burnout Inventory- Emotional Exhaustion Scale): pre-treatment, post-treatment (7 weeks), 6-month follow-up;
- Symptoms of anxiety (Hospital Anxiety and Depression Scale, HADS, Subscale Anxiety): pre-treatment, post-treatment (7 weeks), 6-month follow-up;
- Depressive Symptoms (CES-D): pre-treatment, post-treatment (7 weeks), 6-month follow-up
- Self-reported Emotional Competencies (SEK-27 - Subscales: Acceptance, comprehension, and self support): pre-treatment, post-treatment (7 weeks), 6-month follow-up;
- Self-reported Emotional Competencies - Emotional Specific Version (SEK-ES), subscale stress and tension: pre-treatment, post-treatment (7 weeks), 6-month follow-up;
- Insomnia Severity (Insomnia Severity Index, ISI): pre-treatment, post-treatment (7 weeks), 6-month follow-up;
- Worrying (Penn State Worry Questionnaire, Ultra Short Version): pre-treatment, post-treatment (7 weeks), 6-month follow-up;
- Mental detachment (Recovery Experience Questionnaire – Subscale Mental Detachment): pre-treatment, post-treatment (7 weeks), 6-month follow-up;
- Work-related stress (Effort Reward Imbalance, ERI-S): pre-treatment;
- Measurement of Online-Training Expectancy (confidence): pre-treatment
- The five personality factors (neuroticism, extraversion, agreeableness, openness to experience, conscientiousness): Ultra short version of the NEO-Five-Factor-Inventory: pre-treatment
- Work engagement (Utrecht Work Engagement Scale, UWES): pre-treatment, post-treatment (7 weeks), 6-month follow-up;
- Attitudes toward psychological help: pre-treatment, post-treatment (7 weeks), 6-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-month follow-up;
- Quality of life (SF-12 and EuroQol): pre, 6-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-month follow-up

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2013/11/06
  •   264
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Leuphana Universität LüneburgGET.ON Gesundheitstraining.Online / Innovations-Inkubator,David Daniel Ebert (Ansprechpartner des Sponsors)
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Barmer GEK
    • Lichtscheider Str. 89
    • 42285  Wuppertal
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Ms.  Dipl.-Psych.  Elena   Heber 
    • Rotenbleicherweg 67
    • 21335  Lüneburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Ms.  Elena  Heber 
    • Rotenbleicherweg 67
    • 21335  Lüneburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Barmer GEK
    • Lichtscheider Str. 89
    • 42285  Wuppertal
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Investitions-und Förderungsbank Niedersachsen (NBank)
    • Günther-Wagner-Allee 12-16
    • 30177  Hannover
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • European Union (finanzielle Förderung organisiert über NBank bzw. Niedersächsisches Ministerium für Wirtschaft, Arbeit und Verkehr
    • Friedrichwall 1
    • 30159  Hannover
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.