PMID- 37400899 OWN - NLM STAT- MEDLINE DCOM- 20230705 LR - 20230726 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 24 IP - 1 DP - 2023 Jul 3 TI - Enhancing educational and vocational recovery in adolescents and young adults with early psychosis through Supported Employment and Education (SEEearly): study protocol for a multicenter randomized controlled trial. PG - 440 LID - 10.1186/s13063-023-07462-2 [doi] LID - 440 AB - BACKGROUND: Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies. Early intervention programs for people in the first 5 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 still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery. 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. METHODS: The SEEearly trial compares treatment as usual (TAU) plus SEE to TAU alone in outpatient psychiatric settings. The study is a six-site, two-arm, single-blinded, superiority randomized controlled trial (RCT). Participants are randomly assigned (1:1) to the intervention or control group. Aiming to recruit 184 participants, with an assumed drop-out rate of 22%, we will be able to detect a 24% difference in the main outcome of employment/education with 90% power. We make assessments at baseline and at 6- and 12-month follow-ups. Outcome data on employment/education, medication, and current psychiatric treatment is obtained monthly through phone based short assessments. The primary outcome is steady participation for at least 50% of the 12-month follow-up in competitive employment and/or mainstream education. Secondary employment outcomes capture length of employment/education, time to first employment/education, monthly wages/educational attainment, and social return on investment (SROI). Secondary non-employment outcomes include subjective quality of life, psychopathology, substance use, relapse, hospitalization, and functional impairment. To be eligible, participants must be between 16 and 35 years, fulfill diagnostic criteria for early psychosis, and be interested in competitive employment and/or mainstream education. DISCUSSION: In SEEearly, we hypothesize that participants with psychosis, who receive TAU plus SEE, present with better primary and secondary outcomes than participants, who receive TAU alone. Positive results of this study will justify SEE as an evidence-based strategy for clinical routine treatment in people with early psychosis. TRIAL REGISTRATION: SEEearly was registered nationally and internationally in the German Clinical Trials Register (DRKS; identifier: DRKS00029660) on October 14, 2022. CI - (c) 2023. The Author(s). FAU - Jackel, D AU - Jackel D AD - Department of Psychiatry and Psychotherapy, Charite Campus Mitte, Charite Universitatsmedizin Berlin, Berlin, Germany. AD - Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum am Urban and Vivantes Klinikum im Friedrichshain, Berlin, Germany. FAU - Willert, A AU - Willert A AUID- ORCID: 0000-0002-3399-1088 AD - Department of Psychiatry and Psychotherapy, Charite Campus Mitte, Charite Universitatsmedizin Berlin, Berlin, Germany. anna.willert@charite.de. AD - Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum am Urban and Vivantes Klinikum im Friedrichshain, Berlin, Germany. anna.willert@charite.de. FAU - Brose, A AU - Brose A AD - Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum am Urban and Vivantes Klinikum im Friedrichshain, Berlin, Germany. FAU - Leopold, K AU - Leopold K AD - Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum am Urban and Vivantes Klinikum im Friedrichshain, Berlin, Germany. AD - Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany. FAU - Nischk, D AU - Nischk D AD - Department of Social Psychiatry, Zentrum fur Psychiatrie, Reichenau, Germany. FAU - Senner, S AU - Senner S AD - Department of Social Psychiatry, Zentrum fur Psychiatrie, Reichenau, Germany. FAU - Pogarell, O AU - Pogarell O AD - Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany. FAU - Sachenbacher, S AU - Sachenbacher S AD - Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany. FAU - Lambert, M AU - Lambert M AD - Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Rohenkohl, A AU - Rohenkohl A AD - Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Kling-Lourenco, P AU - Kling-Lourenco P AD - Department of Psychiatry II, University of Ulm and BKH Gunzburg, Ulm, Germany. FAU - Rusch, N AU - Rusch N AD - Department of Psychiatry II, University of Ulm and BKH Gunzburg, Ulm, Germany. FAU - Bermpohl, F AU - Bermpohl F AD - Department of Psychiatry and Psychotherapy, Charite Campus Mitte, Charite Universitatsmedizin Berlin, Berlin, Germany. AD - Psychiatric University Clinic of Charite at St. Hedwig Hospital, Berlin, Germany. FAU - Schouler-Ocak, M AU - Schouler-Ocak M AD - Department of Psychiatry and Psychotherapy, Charite Campus Mitte, Charite Universitatsmedizin Berlin, Berlin, Germany. AD - Psychiatric University Clinic of Charite at St. Hedwig Hospital, Berlin, Germany. FAU - Disselhoff, V AU - Disselhoff V AD - Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum am Urban and Vivantes Klinikum im Friedrichshain, Berlin, Germany. FAU - Skorupa, U AU - Skorupa U AD - Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum am Urban and Vivantes Klinikum im Friedrichshain, Berlin, Germany. FAU - Bechdolf, A AU - Bechdolf A AD - Department of Psychiatry and Psychotherapy, Charite Campus Mitte, Charite Universitatsmedizin Berlin, Berlin, Germany. AD - Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum am Urban and Vivantes Klinikum im Friedrichshain, Berlin, Germany. LA - eng GR - 470569697/Deutsche Forschungsgemeinschaft/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20230703 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM EIN - Trials. 2023 Jul 25;24(1):476. PMID: 37491354 MH - Humans MH - Young Adult MH - Adolescent MH - *Employment, Supported MH - Neoplasm Recurrence, Local MH - *Psychotic Disorders/diagnosis/therapy MH - Educational Status MH - *Substance-Related Disorders MH - Randomized Controlled Trials as Topic MH - Multicenter Studies as Topic PMC - PMC10316586 OTO - NOTNLM OT - Early intervention OT - Early psychosis OT - IPS OT - Recovery OT - Schizophrenia COIS- The authors declare that they have no competing interests. EDAT- 2023/07/04 01:05 MHDA- 2023/07/05 06:42 PMCR- 2023/07/03 CRDT- 2023/07/03 23:40 PHST- 2023/05/18 00:00 [received] PHST- 2023/06/13 00:00 [accepted] PHST- 2023/07/05 06:42 [medline] PHST- 2023/07/04 01:05 [pubmed] PHST- 2023/07/03 23:40 [entrez] PHST- 2023/07/03 00:00 [pmc-release] AID - 10.1186/s13063-023-07462-2 [pii] AID - 7462 [pii] AID - 10.1186/s13063-023-07462-2 [doi] PST - epublish SO - Trials. 2023 Jul 3;24(1):440. doi: 10.1186/s13063-023-07462-2.