Trial document




drksid header

  DRKS00022388

Trial Description

start of 1:1-Block title

Title

JOBS Program Germany for Health Promotion Among the Unemployed in the Community Setting With Institutions for Employment Promotion

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

Trial Acronym

JobsProgramDtl

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

URL of the Trial

https://www.gesundheitsforschung-bmbf.de/de/jobs-programm-deutschland-zur-gesundheitsforderung-bei-arbeitslosen-in-der-kommunalen-11088.php

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

Brief Summary in Lay Language

Compared to the employed, the unemployed are in worse health conditions, particularly with regards to mental health. At the same time, the unemployed are not well reached by health promotion interventions.

The prevention program "Linking of Employment Promotion and Health Promotion in the Community Setting" by the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the health insurance companies, the Federal Employment Agency, Jobcenters, the Association of German Counties, and the Association of German Cities aims at systematically improving the health conditions among the unemployed. For this purpose, the Federal Centre for Health Education (BZgA) coordinates the implementation of the "JOBS program" in Germany.

The "JOBS Program" has improved reintegration into the labor market and health conditions among the unemployed in the USA and Finland. The study assesses whether the "JOBS Program" produces similar positive effects for the unemployed in Germany.

For this purpose, approximately 1,400 unemployed are invited to participate in JOBS trainings. The participating unemployed are randomly assigned to one of two groups that complete JOBS trainings at an interval of six months. Trainings are accompanied by trainer teams and are completed in small groups of 8-15 unemployed for a period of one week in units of five hours a day. Within six months, participants are interviewed by telephone three times in total. Questions include the current employment status and subjective well-being. It is expected that JOBS trainings increase reintegration into the labor market and health conditions.

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

Brief Summary in Scientific Language

Unemployment poses a problem for society as well as a big challenge for health promotion and prevention. Meta-analyzes have shown that compared to the employed, the unemployed are in worse health conditions, particularly with regards to mental health. At the same time, the unemployed are not well reached by health promotion interventions.

The prevention program "Linking of Employment Promotion and Health Promotion in the Community Setting" by the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the health insurance companies, the Federal Employment Agency, Jobcenters, the Association of German Counties, and the Association of German Cities aims at systematically improving the health conditions among the unemployed. The Federal Centre for Health Education (BZgA) coordinates joint activities in 129 locations. Within this context, the "JOBS program" that was developed by the Michigan Prevention Research Center (MPRC) in the USA is implemented in Germany. The "JOBS program" integrates elements of social learning theories and perceived self-efficiency. The training of the trainers follows the protocol of the Finnish Institute for Occupational Health.

Randomized field studies in the USA and Finland found significant positive effects on reintegration into the labor market and health conditions amongst the unemployed in the treatment group. However, from an international comparative perspective, it should be noted that employment promotion and health promotion among the unemployed are closely linked to the country-specific labor market structure and the health and social security systems, respectively. Therefore, the confirmative study assesses whether the "JOBS Program" produces similar positive effects for the unemployed in Germany.

The study implements a two-armed randomized control trial. Following an information event, a total of approximately 1,400 unemployed who are willing to participate are randomly assigned to an intervention or a waiting control group. Accompanied by trainer teams, the intervention group completes JOBS training in small groups of 15-20 unemployed for a period of one week in units of five hours a day. The "JOBS program" combines job application training with elements of social learning theory and self-efficiency. Participants are interviewed before and after the JOBS training in computer-assisted telephone interviews (CATI). A final CATI takes place six months after completing the JOBS training.

The primary outcomes of the study are reintegration into the labor market, subjective state of health, depressive symptoms, psychological distress, and life satisfaction. Of secondary interest are moderating variables, such as socio-demographic characteristics, the duration of unemployment, and the job-search intensity.

Compared to the waiting control group, the intervention group is expected to be more often and better reintegrated into the labor market. Moreover, the intervention group is also expected to assess their health status more favorably, to have lower levels of depressive symptoms and psychological distress, and to report a higher level of life satisfaction.

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?

No

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

  •   DRKS00022388
  •   2020/07/20
  •   [---]*
  •   yes
  •   Approved
  •   keine Vorlage-Nr. vergeben, Ethikkommission des Fachbereichs Humanwissenschaften der Universität Kassel
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

  •   Mental health
  •   Depressive symptoms
  •   Anxiety
  •   Psychological distress
  •   F99 -  Mental disorder, not otherwise specified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   JOBS-Training according to JOBS-Manual (1. job-search skill training, 2. active teaching/learning methods, 3. inoculation against setbacks, 4. trainer referent power, 5. social support), 5 days, 5 hours per day, n=700; The sessions are conceptualized as workshops, let by a pair of co-trainers who facilitate the group activities. In group discussions, participants diagnose problems, identify potential setbacks and difficulties, offering solutions and developing the necessary skills for implementing those solutions. The intervention is based on an adaption of the original JOBS-manual by the Michigan Prevention Research Center (http://www.isr.umich.edu/src/seh/mprc/PDFs/Jobs%20Manual.pdf)
  •   Waiting control group; no intervention for 6 months; thereafter JOBS trainings as in arm 1
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Reintegration into the labor market, subjective state of health (self-evaluation), depressive symptoms (WHO-5, PHQ-9), psychological distress (DASS), and life satisfaction (SWLS) are collected via telephone-interviews (CATI) at three occasions (pre-test, post-test, 6-months-follow-up)

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

Secondary Outcome

Job satisfaction, job-search intensity and duration of unemployment are collected via telephone-interviews (CATI) at three occasions (pre-test, post-test, 6-months-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
  •   2021/04/01
  •   1400
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   64   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Unemployed according to Code of Social Law III

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

Exclusion Criteria

Insufficient command of German language for CATI, Pupils/Students

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Kassel Fachbereich 01, Humanwissenschaften Institut für Sozialwesen, Professur für Theorie und Empirie des Gesundheitswesens
    • Mr.  Prof. Dr.  Alfons  Hollederer 
    • Mönchebergstraße 19
    • 34125  Kassel
    • 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
    • Bundeszentrale für gesundheitliche Aufklärung (BZgA)
    • Maarweg 149-161
    • 50825  Köln
    • 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 other
    • Finnish Institute of Occupational Health (FIOH)
    • P.O. Box 18, FI-00032 TYÖTERVEYSLAITOS
    • Helsinki
    • Finland
    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 other
    • Universität Kassel, Professur für Methoden empirischer Sozialforschung
    • Mönchebergstraße 19
    • 34125  Kassel
    • 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 other
    • GKV-Spitzenverband
    • Reinhardstraße 28
    • 10117  Berlin
    • 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
    • Universität Kassel Fachbereich 01, Humanwissenschaften Institut für Sozialwesen, Professur für Theorie und Empirie des Gesundheitswesens
    • Mr.  Prof. Dr.  Alfons  Hollederer 
    • Mönchebergstraße 19
    • 34125  Kassel
    • 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
    • Universität Kassel Fachbereich 01, HumanwissenschaftenInstitut für Sozialwesen, Professur Theorie und Empirie des Gesundheitswesens
    • Mr.  Daniel  Klein 
    • Mönchebergstraße 19
    • 34125  Kassel
    • 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
    • Bundesministerium für Bildung und Forschung
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

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

Trial Publications, Results and other Documents

  •   Votum der Ethikkommission liegt vor.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.