个体安置和支持（IPS）对物质使用障碍患者的效果评价：IPS 与增强自助对照随机临床试验研究方案。

The effect evaluation of Individual Placement and Support (IPS) for patients with substance use disorders: study protocol for a randomized controlled trial of IPS versus enhanced self-help.

机构信息

Division of Mental Health and Addiction, Oslo University Hospital, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.

Westat, Lebanon, New Hampshire, USA.

出版信息

Trials. 2021 Oct 15;22(1):705. doi: 10.1186/s13063-021-05673-z.

DOI:10.1186/s13063-021-05673-z

PMID:34654464

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8518218/

Abstract

BACKGROUND

Employment is associated with better outcomes of substance use treatment and protects against relapse after treatment completion. Unemployment rates are high for people with substance use disorders (SUD) who undergo treatment, with Norwegian estimates ranging from 81 to 91%. Evidence-based vocational models are lacking for patients in SUD treatment but exist for patients with psychosis in terms of Individual Placement and Support (IPS). The aim of the IPS for substance use disorders (IPS-SUD) trial is to investigate the effect of IPS in a SUD population.

METHODS/DESIGN: The IPS-SUD trial is a randomized controlled trial (RCT) comparing IPS to an enhanced control intervention. The study is a seven-site, two-arm, pragmatic, parallel-group, superiority RCT. Participants are randomly assigned (1:1) to receive either IPS plus treatment as usual (TAU) or to receive a self-help guide book and 12-h workshop plus 1-h individual vocational guidance plus TAU. Aiming to recruit 200 participants, we will be able to detect a 20% difference in the main outcome of employment with 90% power. We will make assessments at inclusion and at 6- and 12-month follow-ups and obtain outcome data on employment from national mandatory registries. The primary outcome will be at least 1 day of competitive employment during the 18-month follow-up period. Secondary employment outcomes will capture the pattern and extent of employment in terms of total time worked (days/hours), time to first employment, number of different jobs, duration of the longest employment, and sustained employment. Secondary non-employment outcomes will be substance use, mental distress, and quality of life measured by validated instruments at 6, 12, and 18 months follow-up assessments. To be eligible, participants must be between 18 and 65 years, currently unemployed and in treatment for SUD.

DISCUSSION

The IPS-SUD trial will provide evidence for the use of IPS in a SUD population. Findings from the study will have implications for service delivery.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04289415 . Registered on February 28, 2020.

摘要

背景

就业与物质使用治疗的更好结果相关，并在治疗完成后预防复发。接受治疗的物质使用障碍（SUD）患者的失业率很高，挪威的估计范围从 81%到 91%不等。尽管有针对精神疾病患者的基于证据的职业模型（如个体安置和支持（IPS）），但针对 SUD 治疗患者的此类模型仍然缺乏。IPS 用于物质使用障碍（IPS-SUD）试验的目的是调查 IPS 在 SUD 人群中的效果。

方法/设计：IPS-SUD 试验是一项随机对照试验（RCT），比较 IPS 与增强型对照组。该研究是一项七站点、双臂、实用、平行组、优效性 RCT。参与者被随机分配（1:1）接受 IPS 加常规治疗（TAU）或接受自助指南手册和 12 小时讲习班加 1 小时个人职业指导加 TAU。研究目标是招募 200 名参与者，我们将能够以 90%的功效检测出主要结局（就业）中 20%的差异。我们将在纳入时和 6 个月和 12 个月随访时进行评估，并从国家强制性登记处获得就业结果数据。主要结局是在 18 个月的随访期间至少有 1 天的竞争性就业。次要就业结果将根据工作总天数/小时、首次就业时间、不同工作的数量、最长就业时间和持续就业来捕捉就业模式和程度。次要非就业结果是在 6、12 和 18 个月随访评估时使用验证工具测量的物质使用、精神困扰和生活质量。参与者必须在 18 岁至 65 岁之间，目前失业并正在接受 SUD 治疗，才有资格参加。