Trial document




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  DRKS00023245

Trial Description

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Title

Leipzig - Individual Placement and Support for people with mental illnesses

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Trial Acronym

LIPSY-Trial

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URL of the Trial

https://static.leipzig.de/fileadmin/mediendatenbank/leipzig-de/Stadt/Jobcenter/Integration/FlyerLIPSYFinal.pdf

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Brief Summary in Lay Language

The study aims at helping people with severe mental illnesses that receive means-tested benefits. We developed two programs to facilitate the return to work process. Program "A" contains IPS (= Individual Placement and Support), an individualized coaching intervention. In contrast to other coachings, IPS-participants quickly return to work. Program "B" contains a booklet with addresses and information to support participants` return to work. All participants receive high quality care at a hospital.
The study investigates the use of IPS with a focus on return to work and mental health.

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Brief Summary in Scientific Language

Work is an essential part of daily life, and it is especially important for individuals with mental health problems (Gühne et al. 2017). Work helps to structure ones` days, facilitate social contacts and financial security, prevent societal stigmatization, and promote quality of life and self-esteem. Individuals receiving means-tested benefits are at a higher risk of being diagnosed with a psychiatric illness compared to those who are employed. In addition, while there is a broad range of vocational (re)integration measures for people with mental illnesses in Germany, the rate of those working in the first labor market is low. The objective of the study is to test the effectiveness of the IPS (= individual placement and support) intervention focusing on individuals with severe mental illnesses that receive means-tested benefits. The IPS intervention aims at maintaining or regaining working ability and at facilitating reintegration into the (first) labor market following a “first place, then train”-approach.
The study aims at implementing a randomized controlled trial. Eligible participants aged between 18 years and local retirement age will be randomly allocated to an intervention group (access to high quality TAU + IPS); or to an active control group (access to high quality TAU + booklet on integration measures). Primary outcome is “having worked at least one day in competitive employment” at t3. Assessments will take place before the intervention at baseline (t0) as well as 6 (t1), 12 (t2), and 18 (t3) months later. Additionally, participants will be psychologically diagnosed at baseline.
The analyses follow the intention-to-treat principle. Participants who enter the intervention phase of their IPS coaching process will be part of a per protocol analysis.

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

Yes

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Description IPD sharing plan:

Anonymous participant data on work ability, well-being and participation will be shared with the "ISG - Institut für Sozialforschung und Gesellschaftspolitik". Therefore, participants will receive an additional information sheet and they will be asked for their informed consent. The ISG will receive data every six months. The data will be transfered as an excel file via a web-based platform. The ISG is entitled to organize an overall evaluation and monitoring of all rehapro (see below) projects.
A study protocol will be available.

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Organizational Data

  •   DRKS00023245
  •   2021/02/22
  •   [---]*
  •   yes
  •   Approved
  •   531/20-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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

  •   Basis: International Statistical Classification of Diseases and Related Health Problems, 10th Revision.

    F1: Mental and behavioral disorders due to psychoactive substance use
    F2: Schizophrenia, schizotypal and delusional disorders
    F3: Mood [affective] disorders
    F4: Neurotic, stress-related and somatoform disorders
    F5: Behavioral syndromes associated with physiological disturbances and physical factors
    F6: Disorders of adult personality and behavior

    Since our focus is on severe mental illnesses, only participants that have been ill for at least two years, with a Global Functioning score below 51 (GAF < 51) will be included.
  •   F10-F19 -  Mental and behavioural disorders due to psychoactive substance use
  •   F20-F29 -  Schizophrenia, schizotypal and delusional disorders
  •   F30-F39 -  Mood [affective] disorders
  •   F40-F48 -  Neurotic, stress-related and somatoform disorders
  •   F50-F59 -  Behavioural syndromes associated with physiological disturbances and physical factors
  •   F60-F69 -  Disorders of adult personality and behaviour
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Interventions/Observational Groups

  •   Active control group: Participants in the active control group receive treatment-as-usual at Helios Park-Klinikum and additionally a booklet on current measures for vocational rehabilitation. There will be addresses of local support for reintegration of the labor market.
  •   Intervention group: Participants in the intervention group will receive treatment-as-usual at Helios Park-Klinikum and additionally the manual-based coaching "Individual Placement and Support".
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

"Having worked for at least 1 day (in competitive employment) at 18-months-follow-up."

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Secondary Outcome

Vocational variables (single items): time until first competitive employment (days), job tenure (days), number of different employments, working time per week (hours), overall time in employment (days), current employment status (yes/no), wish to work. Health-related and psychological variables: return-to-work self-efficacy (RTW-SE), attitudes towards work and work motivation (DIAMO), vocational self-efficacy (BSW), working ability (WAI), health status (EQ-VAS), generic health status (SF-12), depressiveness (PHQ-9), mental health symptoms (Mini-SCL, BSCL-hostility) and alcohol consumption (AUDIT-C).
Assessments will take place before the intervention at baseline (t0) and 18 (t3) months later. The 'wish to work' is the only vocationale variable assessed at baseline. The other vocational variables can be assessed after treatment (earliest at t1).

In addition to the primary outcome and the secondary outcomes, other variables will be assessed to describe the study population and with regard to confounder analyses. For example: sociodemographical variables (age, sex, marital status, education, German citizenship), clinical diagnosis (ICD-10), the subjective prognosis of gainful employment (SPE), cognitive functioning (SCIP-D), health care consumption (FIMPSY), the health domains of WHODAS 2.0, perceived social support (LSNS-6), loneliness (UCLA), optimism (LOT-R), recovery attitudes (RAQ-7), information about substance use (single items), IPS process evaluation (f.e. satisfaction, IPS-fidelity) and information about TAU process at Helios Parkklinikum.

The following secondary outcomes will be assessed at t1 and t2: vocational variables (see above), EQ-VAS, LSNS-6, SF-12, PHQ-9, Mini-SCL, BSCL-Feindseligkeit, AUDIT-C, RTW-SE.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2021/05/04
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria: receiving means-tested benefits, severe mental illness/es, 18 years - local retirement age, GAF score < 51, wish to work on first labor market, willing and capable of giving informed consent, receiving treatment as usual at Helios Park-Klinikum (TAU)

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Exclusion Criteria

Acute intoxication and delirium

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Addresses

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    • Bundesministerium für Arbeit und Soziales
    • Wilhelmstraße 49
    • 10117  Berlin
    • Germany
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    • Helios Park-Klinikum Klinik für Psychiatrie, Psychosomatik und Psychotherapie
    • Ms.  Prof. Dr.  Katarina  Stengler 
    • Morawitzstraße 2
    • 04289  Leipzig
    • Germany
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    • Jobcenter Leipzig
    • Mr.  Christian  Thänert 
    • Georg-Schumann-Str. 171-175
    • 04159  Leipzig
    • Germany
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    • Institut für Sozialmedizin, Arbeitsmedizin und Public Health Medizinische Fakultät Universität Leipzig
    • Ms.  Prof. Dr.  Steffi G.  Riedel-Heller 
    • Philipp-Rosenthal-Straße 55
    • 04103  Leipzig
    • Germany
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    • Helios Park-Klinikum Leipzig
    • Morawitzstraße 2
    • 04289  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Arbeit und Soziales
    • Wilhelmstraße 49
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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