Clinical trial NCT05824117: Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education.
Official title: Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education (SEE): A Randomized Controlled Trial. Acronym: SEEearly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Delusional Disorder
Acute and Transient Psychotic Disorder, Unspecified
Schizophrenia
Schizoaffective Disorder
Other Nonorganic Psychotic Disorders
Unspecified Nonorganic Psychosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 184
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. The investigators compare treatment as usual (TAU) in an outpatient psychiatric setting to TAU plus SEE.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of early psychosis (DSM 5: schizophrenia spectrum and other psychotic disorders (297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) within the last 5 years currently treated as outpatients
* sufficient linguistic and intellectual abilities to take part in the study
* interest in competitive employment or/and mainstream education
* written informed consent

Exclusion Criteria:

* Learning disability or mental retardation as well as insufficient German language abilities (\< A2)
* physical or organic handicap that seriously impede work or educational functioning

Primary outcomes:
measure: Primary outcome
timeFrame: 12 months
Secondary outcomes:
measure: Length of competitive employment or/and mainstream education
timeFrame: 12 months
measure: Time to first competitive job/mainstream education
timeFrame: 12 months
measure: Monthly wages
timeFrame: 12 months
measure: Educational attainment
timeFrame: 12 months
measure: Social return on investment (SROI)
timeFrame: 12 months
measure: Subjective quality of life
timeFrame: 12 months
measure: Psychopathology
timeFrame: 12 months
measure: General substance abuse
timeFrame: 12 months
measure: Cannabis use
timeFrame: 12 months
measure: Relapse
timeFrame: 12 months
measure: Hospitalization
timeFrame: 12 months
measure: Functional impairment
timeFrame: 12 months
measure: Overall functional impairment
timeFrame: 12 months
Other outcomes:
Locations:
city: Reichenau
country: Germany
facility: Klinik für Sozialpsychiatrie, Zentrum für Psychiatrie Reichenau
state: Baden Württemberg
city: München
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, LMU Klinikum
state: Bayern
city: Ulm
country: Germany
facility: Klinik für Psychiatrie, Psychotherapie und Psychosomatik II, Günzburg
state: Bayern
city: Berlin
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie Charité Campus Mitte
city: Berlin
country: Germany
facility: Klinik für Psychiatrie, Psychotherapie und Psychosomatik Vivantes Klinikum am Urban
city: Hamburg
country: Germany
facility: Klinik für Psychiatrie, Universitätsklinikum Hamburg Eppendorf
Study officials:
affiliation: Klinik für Psychiatrie und Psychotherapie, Charite Universitätsmedizin Berlin
name: Andreas Bechdolf, Prof.
role: PRINCIPAL_INVESTIGATOR
References: