Individuals receiving means-tested benefits are at a higher risk of being diagnosed with a psychiatric illness compared to those who are employed, and the rate of those working in the first labor market is low. The intervention (Individual Placement and Support, IPS) aims at maintaining or regaining working ability and at facilitating reintegration into the (first) labor market following a “first place, then train”-approach. The objective of the study is to conduct the first RCT in Germany that addresses a broad group of long-term unemployed individuals with severe mental illnesses that receive means-tested benefits, and to test the effectiveness of the IPS intervention. In this randomized controlled trial, about 120 eligible participants aged between 18 years and local retirement age will be randomly allocated to an intervention group (IG) or to an active control group (CG) using a parallel arm design. The IG will receive IPS + high quality treatment as usual (TAU), the active CG will receive TAU + a booklet on integration measures. A block-randomization algorithm with a targeted assignment ratio of 1:1 for participants in IG and active CG will be used, stratified by sex and three age groups. Assessments will take place before the intervention at baseline (t0), and 6 (t1), 12 (t2), and 18 (t3) months later. Primary outcome will be the proportion of participants having worked at least 1 day in competitive employment since baseline, as assessed at t3. Secondary outcomes will be related to employment/ vocation and mental health. In addition, there will be a process evaluation. Treatment effects on outcomes will be tested using appropriate panel-data regression models, and acceptability, uptake and adherence will be evaluated using descriptive statistics and appropriate inference testing. The results of this trial are expected to generate a better understanding of the efficiency, feasibility, acceptance, and relevance of the IPS intervention in a German setting. They could be a first step towards the implementation of the method and towards improving the situation of long-term unemployed individuals with severe mental health problems. German Clinical Trials Register ( DRKS00023245 ), registered on 22.02.2021.

中文翻译：

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莱比锡 - 精神疾病患者的个人安置和支持 (LIPSY)：随机对照试验的研究方案

与就业者相比，接受经济状况调查福利的个人被诊断患有精神疾病的风险更高，而且在第一劳动力市场工作的人的比例较低。干预措施（个人安置和支持，IPS）旨在保持或恢复工作能力，并按照“首先安置，然后培训”的方法促进重新融入（第一）劳动力市场。该研究的目的是在德国开展首次随机对照试验，针对患有严重精神疾病且接受经济状况调查福利的长期失业人员进行广泛群体调查，并测试 IPS 干预措施的有效性。在这项随机对照试验中，约 120 名年龄在 18 岁至当地退休年龄之间的合格参与者将采用平行臂设计随机分配到干预组 (IG) 或主动对照组 (CG)。IG 将获得 IPS + 照常高质量待遇 (TAU)，现役 CG 将获得 TAU + 一本关于融合措施的小册子。将使用块随机化算法，对 IG 和主动 CG 参与者的目标分配比例为 1:1，按性别和三个年龄组进行分层。评估将在干预前的基线 (t0) 以及 6 (t1)、12 (t2) 和 18 (t3) 个月后进行。主要结果将是自基线以来在竞争性就业中工作至少 1 天的参与者的比例（在 t3 时评估）。次要结果将与就业/职业和心理健康有关。此外，还将进行过程评估。将使用适当的面板数据回归模型来测试治疗对结果的影响，并使用描述性统计和适当的推理测试来评估可接受性、接受性和依从性。该试验的结果预计将使人们更好地了解 IPS 干预措施在德国的效率、可行性、接受度和相关性。它们可能是实施该方法和改善患有严重心理健康问题的长期失业者状况的第一步。德国临床试验登记册 (DRKS00023245)，于 2021 年 2 月 22 日注册。