Trial document




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  DRKS00023457

Trial Description

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Title

Evaluation of a stress management intervention for leaders in small to medium sized companies

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Trial Acronym

KMU-GO

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URL of the Trial

https://www.kmu-go.de/

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Brief Summary in Lay Language

Occupational stress is a common phenomenon in the modern working environment. Prevention programs for stress reduction are despite the fact that most workers work in small to medium-sized bussinesses almost exclusive to large concerns. People in leadership positions are a particularily burdened group.
The present study seeks to conduct and evaluate a stress management program, which in the past has been successfully implemented in a large company, in a new setting. The target group are leaders of all genders and hierachy levels in small and medium-sized bussinesses. Start of the training sessions is in early 2021.The training aims to increase the sensibility for stress and self-care in leaders, as well as increase their competence in stress preventive and employee-oriented management. It tries to incorporate the needs of the individual, the working conditions and the goals of the firm.
To evaluate the success of the program common questionnaires and physiological measures are assessed multiple times during the course of the study.

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Brief Summary in Scientific Language

In the german working environment increasing work intensification, as well as increasing work complexety are being recognized (Lohmann-Haislah, 2012). This leads to higher subjective stress in the work place. A european survey reports gratification crisis for more than 20% of the german workers. Other forms of stress are even more frequently reported (Niedhammer et al., 2012).
Leaders are a particularly relevant target group. They fullfill a double role, because they are exposed to many stressors (Lovelace et al., 2007), while they are also influencing the stress and health of their subordinates through their leadership.
Trainings for stress management are oftentimes only used in large concerns. A previous study succesfully implemented the training for male leaders in a large metalworking concern in south-west germany. The present study aims to evaluate the training in a new setting. The target group are leaders of all genders and hierarchy levels in small to medium sized companies.
For the evaluation common questionnaires and physiologicial parameters are assessed multiple times during the course of the study. Additionally a survey with the respective subordinates is conducted to examine the indirect influence of the training on the subordinates. The stress management training contains a 1.5 day training as well as two additional booster sessions (each 180min).

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00023457
  •   2020/11/05
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  •   yes
  •   Approved
  •   354/20, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   stress reacitvity
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Interventions/Observational Groups

  •   Group 1: Leaders from small to medium sized companies, who participate in a 1.5 day stress management training and two additional booster sessions three and six month after training (each 180min).
  •   Group 2: Wait-list control: Leaders from small to medium sized companies, who participate twelve months after the intervention group in the same 1.5 day stress management training followed by two additional booster sessions three and six month after the training (each 180min).
  •   Group 3: Subordinates of the participating leaders.
    Additionally, SME employees without any personnel responsibility will be interviewd in advance, addressing beneficial as well as inconvenient factors concernig the survey.
  •   Group 4: Stakeholders (leaders from small to medium sized companies or cooperation partners), who are interviewed with the aim to adapt the training to the specific needs of the target group
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   III
  •   No
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Primary Outcome

Data will be collected at multiple measurement dates.
Group 1: T0(two weeks prior to the training),T1(six months after the training), T2(twelve months after the training). At all three measurement dates health-related questions (single-items), stress reactivity (PSRS-23), gratification crisis (ERI), anxiety and depression (HADS), the relationship between leader and member (LMX-7), professional self-efficacy (BSWE), the working atmosphere with regard to psychosocial safety (PSC-4), self-regulation and self-awareness (OPD-SF), the Client Sociodemographic and Service Receipt Inventory (CSSRI) , as well as the EuroQol's questionnaire for health related quality of life (EQ-5D 5L) are assessed. Additionally at T0 and T2 physiological measures are conducted (24h heart rate variability, hair cortisol and alpha-amylase).

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Secondary Outcome

In addtiion to the survey of the participating managers, it is planned to also question their employees at t0, t1 und t2. Therefore, work related (KFZA, ERI, IS) and health related (WHO-5) data will be collected. Also, the employees will be asked about the interaktion with the manager (LMX-7). In addition to the questionnaire data, serial, qualitative interviews with employees are conducted and evaluated for T0 and T2.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2020/11/15
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Workers of small to medium sized companies (< 499 employees), who (1) have management responsibility, (2) are 18-65 years old and (3) are more than two years away from retirement.

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Exclusion Criteria

planned retirement within the following two years

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Addresses

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    • Uniklinikum für Psychosomatische Medizin und Psychotherapie
    • Mr.  Prof. Dr. med.  Harald  Gündel 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Kompetenzzentrum für Psychische Gesundheit am Arbeitsplatz der Universitätsklinik Ulm (LPCU)
    • Ms.  M. Sc.  Elena  Schwarz 
    • Kornhausgasse 9
    • 89073  Ulm
    • Germany
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    • Kompetenzzentrum für Psychische Gesundheit am Arbeitsplatz der Universitätsklinik Ulm (LPCU)
    • Mr.  M. Sc.  Michael  Gast 
    • Kornhausgasse 9
    • 89073  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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  •   179
  •   179
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.