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临床试验/NCT04975750
NCT04975750进行中(未招募)不适用

Early Prevention of Sick Leave at the Workplace: Design of a Cluster-randomized Controlled Trial of a Problem-solving Intervention Among Employees With Common Mental Disorders

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2021年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
170
试验地点
2
主要终点
Sick leave

研究概览

简要总结

The overall aim of this randomized controlled trial is to evaluate the effectiveness of a problem-solving intervention for the prevention of sick leave among employees with early signs of CMDs. The intervention is delivered by first-line managers and a 30% reduction in sick leave days is expected in the experimental condition compared to treatment-as-usual, during the 12- months follow-up.

详细描述

The overall aim of this randomized controlled trial is to evaluate the effectiveness of a problem-solving intervention for the prevention of sick leave among employees with early signs of CMDs. The intervention is delivered by first-line managers and a 30% reduction in sick leave days is expected in the experimental condition compared to treatment-as-usual, during the 12- months follow-up.

In an alongside process evaluation on the intervention's core activities, i.e. identification of early signs of CMDs, training of first-line managers in problem-solving and communication, we will:

  • evaluate whether and to what extent it was possible for the first-line managers to adhere to the intervention's protocol,
  • investigate the association between the intervention's core activities and number of sick leave days,
  • identify the facilitators and barriers to the intervention among first-line managers and employees and,
  • explore the first-line manager's organizational resources supporting their general managerial work.

The study will be conducted in private sector companies, among first-line managers and blue-collar workers. The outcomes will be evaluated on both cluster- and individual participant level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • scoring with a cut-off ≥3 points on the GHQ-12, or a positive answer on the question on risk of SA, namely employee believes that he/she will receive a sickness certification due to stress, anxiety, or depression the following 12 months.
  • negative answer on the question on bullying, namely employee has not been exposed to bullying by his or her first line manager.
  • understand written and spoken Swedish.

排除标准

  • Ongoing sick leave (full- or part-time), leave of absence, pregnancy.
  • Sick leave ≥14 calendar days during the last 3 months due to CMD.
  • At the time for inclusion planned long-term absence during the coming year (for example parental leave, new job, retirement).

研究组 & 干预措施

Problem solving intervention

Experimental

Problem solving as developed by Nexu and colleguages. First-line managers are trained in the problem solving intervention (1 1/2 day). Thereafter, they apply the problem-solving in 2 - 5 meetings (about 30 - 45 min each) with employees at risk of future sick leave due to common mental disorders.

干预措施: Problem solving intervention (Behavioral)

结局指标

主要结局

Sick leave

时间窗: From baseline until 12 months

The total number of days on sick leave due to CMDs (including the first 14 calendar days compensated by the employer) during the 12 month follow-up period

次要结局

  • Work performance(From baseline until the 12-month follow-up)
  • Self-rated general health(From baseline until the 12-month follow-up)
  • Work ability(From baseline until the 12-month follow-up)
  • Depressive and anxiety symptoms(From baseline until the 12-month follow-up)
  • Self-rated exhaustion(From baseline until the 12-month follow-up)
  • Psychosocial work environment(From baseline until the 12-month follow-up)
  • Work stress(From baseline until the 12-month follow-up)
  • Life-work conflict(From baseline until the 12-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabeth Björk Brämberg, PhD

Docent, Associate Professor, PhD

Karolinska Institutet

研究点 (2)

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