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临床试验/NCT05963308
NCT05963308已完成不适用

Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention

Université du Québec a Montréal2 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2023年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
123
试验地点
2
主要终点
Sustainable return-to-work

研究概览

简要总结

The purpose of this clinical trial is to evaluate the impact of an online group intervention called Healthy Minds in facilitating a sustainable return to work for individuals with a mood disorder. The study aims to answer the following key questions :

  • Does receiving the Healthy Minds online intervention lead to a more sustainable return to work compared to not receiving the intervention?
  • Are the health outcomes (e.g., depressive symptoms) and work-related outcomes (e.g., work functioning) of individuals who receive the Healthy Minds online intervention better than those who do not receive the intervention in the year following the intervention?

Both experimental and control participants will be recruited at baseline while on sick leave (expected to return to work in less than one month) or recently returned to work (less than one month). Participants will complete a series of online questionnaires at the following time points :

  • Baseline
  • First follow-up (2 months after baseline)
  • Second follow-up (6 months after baseline)
  • Third follow-up (12 months after baseline)

The questionnaires will cover the following areas :

  • Sociodemographic and biopsychosocial factors
  • Symptoms associated with the primary mood disorder
  • Cognitive difficulties and biaises
  • Self-efficacy related to return to work
  • Work accommodations and natural supports
  • Relationship with immediate supervisor
  • Work functioning
  • Return to work time (number of days away from work)

Experimental participants will participate in the 2-month online Healthy Minds group intervention (cohort of 5 participants) between the baseline assessment and the first follow-up. The intervention consists of 8 sessions (one per week for 8 weeks), with each session focusing on a specific aspect of the return-to-work process from a cognitive-behavioral perspective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be in the process of returning to work after depression, anxiety disorder, adjustment disorder (with depressed mood, or anxious mood).
  • Been back for less than a month

排除标准

  • Inability to communicate in French
  • Have a known organic disorder
  • Have already received CBT-type intervention (group or individual)

研究组 & 干预措施

Online group intervention "Healthy Minds"

Experimental

干预措施: Healthy Minds (Behavioral)

Control group

No Intervention

Like the intervention group, the control group will complete an online set of questionnaires at the following time points:

  • Baseline
  • First follow-up (2 months after baseline)
  • Second follow-up (6 months after baseline)
  • Third follow-up (12 months after baseline)

The questionnaires will cover the following domains:

  • Sociodemographic and biopsychosocial factors
  • Symptoms associated with the primary mood disorder
  • Cognitive difficulties and distortions
  • Self-efficacy in relation to returning to work
  • Work accommodations and natural supports
  • Relationship with immediate supervisor
  • Work functioning
  • Return-to-work time (number of days away from work)

结局指标

主要结局

Sustainable return-to-work

时间窗: Baseline; follow-ups at six months and 12 months

The number of days of job retention after returning to work

Relationship with immediate supervisor

时间窗: Follow-ups at six months and 12 months

Inventory of perceptions of supervisory style at work

Depressive symptoms

时间窗: Baseline; follow-ups at two months, six months and 12 months

Patient Health Questionnaire for depression (PHQ-9)

Return to Work Obstacles and Self-Efficacy

时间窗: Baseline ; Follow-ups at two months

Return to Work Obstacles and Self-Efficacy Scale (ROSES)

Work functioning

时间窗: Follow-ups at six months and 12 months

Endicott Work Productivity Scale (EWPS)

Cognitive difficulties

时间窗: Baseline ; Follow-ups at two months, six months and 12 months

Online Stroop test (French version)

Anxiety symptoms

时间窗: Baseline ; follow-ups at two months, six months and 12 months

Generalized Anxiety Disorder Scale (GAD-7)

Work accommodations

时间窗: Follow-ups at six months and 12 months

The Work Accommodation and Natural Support Scale (WANSS).

Cognitive biases

时间窗: Baseline ; Follow-ups at two months, six months and 12 months

Davos Assessment of the Cognitive Biases Scale

次要结局

未报告次要终点

研究者

发起方
Université du Québec a Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Corbière

Full Professor

Université du Québec a Montréal

研究点 (2)

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