Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education.

NCT ID: NCT05824117

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2025-03-31

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.

Conditions

Persistent Delusional Disorder; Acute and Transient Psychotic Disorder, Unspecified; Schizophrenia; Schizoaffective Disorder; Other Nonorganic Psychotic Disorders; Unspecified Nonorganic Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group (TAU+SEE)

The experimental intervention is treatment as usual (TAU) for adolescents and young adults with early psychosis in the respective recruitment centers for 12 months plus Supported Employment and Education following the Individual Placement and Support model.

Group Type: EXPERIMENTAL

Individual Placement and Support (IPS)

Intervention Type: OTHER

IPS is an evidence-based practice for helping people with severe mental illness to gain and maintain competitive employment or/and mainstream education with nine well defined key principles that can be reliably assessed by the IPS Fidelity Scale for Young Adults.

Interventions range from engagement techniques (i.e. motivational interviewing) to individualized education/employment searches and from experience-based educational/employment assessment to benefits in counseling/work incentives planning.

Control Group (TAU)

The control condition is treatment as usual (TAU) for adolescents and young adults with early psychosis in the respective recruitment centers for 12 months (including medical review, pharmacological treatment, and psychosocial support: group programs and social counseling to external government-funded vocational programs).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individual Placement and Support (IPS)

IPS is an evidence-based practice for helping people with severe mental illness to gain and maintain competitive employment or/and mainstream education with nine well defined key principles that can be reliably assessed by the IPS Fidelity Scale for Young Adults.

Interventions range from engagement techniques (i.e. motivational interviewing) to individualized education/employment searches and from experience-based educational/employment assessment to benefits in counseling/work incentives planning.

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Andreas Bechdolf

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Bechdolf, Prof.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Psychiatrie und Psychotherapie, Charite Universitätsmedizin Berlin

Locations

Klinik für Sozialpsychiatrie, Zentrum für Psychiatrie Reichenau

Reichenau, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Klinik für Psychiatrie und Psychotherapie, LMU Klinikum

München, Bavaria, Germany

Site Status: RECRUITING

Klinik für Psychiatrie, Psychotherapie und Psychosomatik II, Günzburg

Ulm, Bavaria, Germany

Site Status: RECRUITING

Klinik für Psychiatrie und Psychotherapie Charité Campus Mitte

Berlin, , Germany

Site Status: RECRUITING

Klinik für Psychiatrie, Psychotherapie und Psychosomatik Vivantes Klinikum am Urban

Berlin, , Germany

Site Status: RECRUITING

Klinik für Psychiatrie, Universitätsklinikum Hamburg Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Anna Willert, Dr. med.

Role: CONTACT

anna.willert@charite.de

+4930130226001

Facility Contacts

Daniel Nischk, Dr.

Role: primary

Oliver Pogarell, Prof.

Role: primary

Nicolas Rüsch, Prof.

Role: primary

Anna Willert, Dr. med.

Role: primary

anna.willert@charite.de

Dorothea Jäckel, Dipl. Psych.

Role: primary

dorothea.jaeckel@vivantes.de

Anja Rohenkohl, Dr.

Role: primary

Other Identifiers

DRKS00029660

Identifier Type: REGISTRY

Identifier Source: secondary_id

470569697

Identifier Type: -

Identifier Source: org_study_id