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临床试验/NCT05240495
NCT05240495已完成不适用

Work-focused Versus Generic Internet-based Interventions for Employees With Stress-related Disorders - a Randomized Controlled Trial

Linkoeping University2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2017年1月20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
182
试验地点
2
主要终点
Shirom-Melamed Burnout Questionnaire

研究概览

简要总结

Objective The aim of the current study was to evaluate the efficacy of an internet-based cognitive-behavioural intervention for stress-related disorders integrating work-related aspects (W-iCBT), compared with a generic iCBT and a waitlist control group (WLC).

Method In this trial, 182 employees, mainly employed in the healthcare, IT or educational sector, who fulfilled the criteria for a stress-related disorder, were randomized to a 10-week W-iCBT (n=61), generic iCBT (n=61) or WLC (n=60). Self-rated questionnaires on perceived stress, burnout, exhaustion and other mental-health and work-related outcomes were administered pre- and post-treatment, and at a six- and 12-months follow-up.

Results Compared to WLC, participants of the W-iCBT and iCBT showed equal and significant reduction on the primary outcome (SMBQ) from pre to post assessment (d=1.00 and 0.83 respectively) and at the six months follow-up (d=0.74 and 0.74). Significant moderate-to-large effect sizes were also found on the secondary health and work-related outcomes. The W-iCBT was the only group who exhibited significant effects on work ability and sickness absence. Sickness absence was 445 days (7.29 days per participant) lower compared to the WLC and 324 days (5.31 days per participant) compared to the iCBT intervention. However, no significant differences were found on work experience or long-term sick leave.

Conclusion The work-focused and generic iCBT interventions proved to be superior and equally effective compared to the control condition in reducing chronic stress and several other mental health related symptoms. Interestingly, effects on work ability and sickness absence were only seen between the work-focused iCBT intervention and the WLC. These preliminary results are promising, as they provide further evidence that treatments that integrate work-aspects has great potential in accelerating both recovery and reduce sickness absence due to stress-related disorders.

详细描述

Introduction Work is an important part of life, contributing to both health and wellbeing for many employees. However, in recent years, stress-related disorders have received more attention, with an increasing prevalence within the working population. For example, every fourth employee within the European union has experienced stress during most of their working day. Long-term exposure to stressors, such as job strain or interpersonal conflicts, without sufficient recovery, can lead to a dysregulation in the allostatic system, "allostatic load", which constitutes the fundamental features in the development of chronic stress or stress-related disorders. The major diagnostic systems, Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and International Statistical Classification of Diseases and Related Health Problems (ICD-10 and 11) includes sections regarding stress-related disorders. However, the DSM and ICD systems lack an established terminology and criteria for stress induced fatigue and exhaustion. Consequently, the diagnosis "Exhaustion disorder" (ED) was introduced in the Swedish version of the ICD-10 in 2005. ED is manifested by symptoms of extensive mental and physical fatigue, lack of initiative and endurance and prolonged recovery after mental or physical effort. Later international publications have suggested that ED is not an exclusive Swedish condition. Few studies have been published regarding the prevalence of ED, but in a recent study, based on physician-based diagnosis in 3406 participants, 4.2% reported ED.

In addition to stress-related disorders and well-known health implications, such as coronary artery disease, lowered immune functioning, anxiety, depression and insomnia, chronic stress have been associated with impaired work functioning and problems in work participation such as sickness absence and long-term sick leave. In Sweden, for example, stress-related disorders accounted for one fifth of all sick leave during 2019. Decreased work participation is problematic as it has direct effects on people's well-being and leads to immense costs for society. For instance, the total estimated annual costs for work-related stress observed in seventeen OECD countries is considerable, ranging from US $221 million to $187 billion. Given these rising costs, it is not surprising that many policy makers view stress as a major public health issue and are seeking advice on the types of interventions that may be effective.

During the last decades, psychological interventions have been developed in order to increase the individual's psychological resources and resilience to stress. Evidence suggest that stress management interventions are effective in reducing stress in the working population. These results apply to controlled studies targeting general and milder forms of stress-related ill health. However, considering clinical samples, interventions has been less successful, with small effect sizes.

Traditionally, psychological treatments for stress and common mental disorders have not explicitly focused on work-related aspects, such as reducing sickness absence (SA). Recent evidence suggests that psychological interventions are slightly more effective than treatment-as-usual in reducing sickness absence (small effect sizes). However, it is still uncertain what moderates these effects. There are some indications that work directed interventions in combination with psychological treatment are effective with respect to return-to-work (RTW) for those absent with common mental health problems. In a quasi-experimental study by Lagervelt and colleagues comparing CBT to work-focused CBT, full RTW occurred 65 days earlier and partial RTW 12 days earlier in the work-focused CBT group. A significant decrease in mental health problems was equally present in both conditions. These results suggest that by integrating work-related aspects early into the treatment, problems with sickness absence and long-term sick leave can be reduced.

Despite the well-documented efficacy of stress management interventions, and some promising results of work-focused interventions, the range of interventions are not proportionate to the needs among distressed employees. This clarifies the need to further develop and evaluate work directed interventions that are accessible to the working population.

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
Single (Participant)

盲法说明

Single blinded

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants were employees who had volunteered for the trial. To be eligible for the study, they had to fulfil the criteria for an adjustment disorder described in the subdivision F43 Reaction to severe stress, and adjustment disorders of the ICD-
  • The diagnosis was established through telephone interviews using the Mini International Neuropsychiatric Interview, additional criteria from the International Statistical Classification of Diseases and Related Health Problems (ICD-10; 25), and national diagnostic guidelines regarding stress-related disorders.
  • In addition to an adjustment disorder, participants had to fulfil the following criteria: (i) a minimum age of 18 years, (ii) mastering Swedish, (iii) have access to a computer or a tablet computer with internet-access, (iv) currently employed, (v) score of >1.5 points on the Shirom Melamed Burnout Questionnaire (SMBQ), <34 points on the Montgomery Åsberg Depression Scale-Self Rated (MADRS-S), <21 points on the Insomnia Severity Index (ISI) and <14 points on the Alcohol Use Disorders Identification Test (AUDIT). Mild to moderate forms of DSM axis-I diagnosis were accepted as co-morbid conditions, as long as these were considered to be secondary to the primary adjustment disorder. Participants' on full- or part-time sick leave, one year or less, were also included.

排除标准

  • Participants were excluded from the study if they (i) currently in treatment for stress-related disorder, (ii) currently were suffering from bipolar disorder, psychosis, post-traumatic stress disorder (PTSD), eating disorder, substance abuse, severe forms of depression, anxiety disorder or personality disorders, or (iv) were showing suicidal ideation based on item 9 of the MADRS-S. Participants on medication (e.g., antidepressants or sleep medication) were not excluded from the study but were requested to keep their medication constant during the study period.

结局指标

主要结局

Shirom-Melamed Burnout Questionnaire

时间窗: Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment

The Shirom-Melamed Burnout Questionnaire (SMBQ; Melamed et al., 1992, 1999), is a 22-item scale (graded 1-7) used to assess different aspects of chronic stress and burnout (Physical Fatigue, Cognitive weariness, Tension, and Listlessness). This scale correlates significantly \[58\] with other well established questionnaires measuring burnout, e.g., Maslach Burnout Inventory \[59\]. The SMBQ has an internal consistency reliability (Cronbach's alpha) of .92. \[56\].

次要结局

  • Montgomery Åsberg Depression Rating Scale(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)
  • Alcohol Use Disorders Identification Test(Change between baseline and end of treatment after ten weeks)
  • Perceived Stress Scale(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)
  • Generalised Anxiety Disorder Scale(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)
  • Work Experience Measurement Scale(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)
  • Work Ability Index(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)
  • Sheehan Disability Scale(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)
  • Karolinska Exhaustion Disorder Scale(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)
  • Insomnia Severity Index(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)
  • Recovery Experiences Questionnaire(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)
  • Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry(Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gerhard Andersson

Professor

Linkoeping University

研究点 (2)

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