Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Charité Universitätsmedizin Berlin, Berlin, Germany.
Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum am Urban and Vivantes Klinikum im Friedrichshain, Berlin, Germany.
Trials. 2023 Jul 3;24(1):440. doi: 10.1186/s13063-023-07462-2.
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.
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.
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.
SEEearly was registered nationally and internationally in the German Clinical Trials Register (DRKS; identifier: DRKS00029660) on October 14, 2022.
精神病通常会发展为慢性病程，给个人、家庭和社会带来毁灭性的后果。对于首次精神病发作后 5 年内的人群（早期精神病），早期干预计划可以显著改善预后，因此在国家和国际指南中强烈推荐。然而，大多数早期干预计划仍侧重于改善症状和预防复发，而不是针对教育和职业康复。本研究旨在探索在早期精神病患者中采用个体安置与支持（IPS）模型的支持性就业和教育（SEE）的效果。
SEEearly 试验将常规治疗（TAU）加 SEE 与单独 TAU 进行比较，在门诊精神科环境中进行。该研究是一项六站点、双臂、单盲、优效性随机对照试验（RCT）。参与者被随机分配（1:1）到干预组或对照组。研究旨在招募 184 名参与者，假设脱落率为 22%，我们将能够以 90%的功效检测到主要结局就业/教育的 24%差异。我们在基线和 6 个月及 12 个月的随访时进行评估。通过基于电话的短期评估每月获取就业/教育、药物和当前精神科治疗的结果数据。主要结局是在至少 50%的 12 个月随访期内稳定参与竞争性就业和/或主流教育。次要就业结果包括就业/教育的持续时间、首次就业/教育的时间、每月工资/教育程度和社会投资回报率（SROI）。次要非就业结果包括主观生活质量、精神病理学、物质使用、复发、住院和功能障碍。符合条件的参与者必须在 16 至 35 岁之间，符合早期精神病的诊断标准，并对竞争性就业和/或主流教育感兴趣。
在 SEEearly 中，我们假设接受 TAU 加 SEE 的精神病患者的主要和次要结局优于接受 TAU 单独治疗的患者。该研究的积极结果将证明 SEE 是早期精神病患者临床常规治疗的一种基于证据的策略。
SEEearly 于 2022 年 10 月 14 日在德国临床试验注册中心（DRKS；标识符：DRKS00029660）在全国和国际范围内注册。
