Leipzig - Individual Placement and Support for people with mental illnesses

Leipzig - Individual Placement and Support for people with mental illnesses - LIPSY-Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023245

Enrollment

120

Registered

2021-02-22

Start date

2021-05-04

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basis: International Statistical Classification of Diseases and Related Health Problems, 10th Revision.F1: Mental and behavioral disorders due to psychoactive substance useF2: Schizophrenia, schizotypal and delusional disordersF3: Mood [affective] disordersF4: Neurotic, stress-related and somatoform disordersF5: Behavioral syndromes associated with physiological disturbances and physical factorsF6: Disorders of adult personality and behaviorSince our focus is on severe mental illnesses, only par

Interventions

Group 1: 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.

Eligibility

Sex/Gender

All

Age

18 Years to 67 Years

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: Acute intoxication and delirium

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026