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临床试验/NCT04025905
NCT04025905已完成不适用

REMEDEMPLOI: Social Cognition Training and Vocational Rehabilitation

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2020年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149
试验地点
2
主要终点
Change from baseline in total number of hours worked

研究概览

简要总结

Social cognition impairments, frequently encountered in Serial Mental Illness, reduce the ability to find and to keep a job. Cognitive remediation and social cognition training reduce the impact of cognitive impairments on work outcomes . The purpose of this research is to associate a social cognition training program to vocational rehabilitation in the transition network (transitional Workforce Assistance Facilities and Services) to help people to maintain their jobs and to access to work in an ordinary environment. To support the development of social cognition interventions, additional care (users will retain their usual medical follow-up) will be implemented within the Workforce Assistance Facilities and Services.

This project is part of a strong partnership between the Cognitive remediation network (health sector: rehabilitation centers) and the Transition network (medico-social sector: three Workforce Assistance Facilities and Services having partnerships with rehabilitation centers). This partnership has been experienced previously in the RemedRehab project funded by the 2012 hospital clinical research program (PHRC). This project was recently completed.

详细描述

Social cognition training concomitant to work help to maintain employment in transitional Workforce Assistance Facilities and Services .

Participation in the study will be offered to anyone with severe psychic disorders and a social cognition disorder who started working in one of the transitional Workforce Assistance Facilities and Services in the year prior to inclusion to limit selection bias.

The study population is defined by the transitional Workforce Assistance Facilities and Services users involved.

The diagnosis is not included in the inclusion criteria. It will, however, be established according to DSM-5 criteria for included users, who will benefit from a semi-structured interview .

The expected benefits in the social cognition training programgroup are: best job maintaining rate in transitional Workforce Assistance Facilities and Services , improvement of social cognition, improvement of interpersonal skills, improvement of self-esteem, improvement of professional insertion and improvement of the patient's vision of his place in society.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

Randomization will be stratified by site, and history of previous work in supported employment (≥ 1 year working in the ESAT prior to enrollment) so that each treatment is implemented in 3 groups of 10 people in each of the three centers.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of a serious mental illness (The specific diagnosis is not included in the inclusion criteria. It will, however, be established according to DSM-5 criteria for included users, who will benefit from a semi-structured interview (MINI, Sheehan et al., 1998).
  • Admission in an ESAT in the last year prior to enrollment
  • Expected duration of employment beyond two years
  • Tutor's agreement (for persons under tutorship)
  • Affiliation to social insurance

排除标准

  • Absence of a social cognition disorder at neuropsychological evaluations
  • Simultaneous participation in a social cognition remediation program
  • Insufficient level of understanding of French to participate in the group (verbal exchanges)
  • Insufficient visual acuity to participate in the group (use of slideshow in the group sessions)

结局指标

主要结局

Change from baseline in total number of hours worked

时间窗: 6 months

Difference between the total number of hours worked compared to the number of working hours provided for in the work contract for 6 months

次要结局

  • Change from baseline in self-esteem(6 months)
  • Change from baseline in social cognitive(6 months)
  • Change from baseline in self-stigmatization(6 months)
  • Change from baseline in the recovery process(6 months)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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