SAFARI-Return to Work: Promoting Health and Productivity in Workers With Common Mental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Return to work
研究概览
简要总结
Evidence-based clinical treatments for common mental disorders, such as CBT and/or pharmacotherapy, have resulted in significant and sustained improvement in clinical symptoms. However, the individual-focused treatments rarely have sickness absence as a target of intervention or evaluate work-related outcomes, such as return to work. A recent review of the evidence for managing stress at work showed that individual interventions give effects on mental health measures but did not impact absenteeism at work. The purpose of this study is to examine the efficacy and cost-effectiveness of two different rehabilitation models, one based on psychotherapy and the other on workplace-interventions, when these are offered as standalone interventions and in combination for patients with adjustment, anxiety and depressive disorders.
详细描述
Common mental disorders, such as adjustment, anxiety and depressive disorders are highly prevalent in the working population and are associated with impaired work functioning and high sick leave rates. For mental health disorders, several established treatments exist, such as Cognitive Behavior Therapy (CBT), pharmacotherapy, and physical activity. However, less evidence is available on which treatments that increase an individual's ability to return to work (RTW) when he/she has a common mental disorder. In particular, the effectiveness of a psychotherapeutic intervention for RTW is largely unknown even though these types of interventions are common and are recommended by the National Board of Health and Welfare for common mental disorders in Sweden. The few studies in which psychotherapeutic interventions (mostly CBT) have been evaluated indicate that these were equally or less effective in enhancing RTW compared to other interventions. In the Swedish rehabilitation guarantee, CBT-treatments are subsided based on the assumption that improved health status will contribute to earlier RTW. However, the results from the first evaluations of the rehabilitation guarantee point to the contrary. RTW was actually delayed for CBT for common mental disorders compared to treatment as usual (TAU) (5).
Traditionally, CBT manuals have been oriented towards reducing symptoms. Likewise, outcome measures generally consist of symptom-based scales. In a recent study, a specific RTW CBT-manual was developed including targeting return to a work context, resulting in earlier RTW. Self-reported mental health symptoms were reduced to a similar extent as in regular CBT. This implies a room for improvement in the CBT-manuals through orienting the treatment towards specific areas of functioning, without a loss of symptom specific improvement.
Even though CBT has proven effective for several mental conditions, little is known about why the interventions lead to change or how the change came about. This is especially true when it comes to RTW. There are various treatment intents with varying results, however, little or nothing is known beyond subjective reasoning about the active processes in treatment, mediators that might lead to reduced sickness absence. Moderators refer to characteristics that influence the direction or magnitude of the relation between the intervention and outcome. There are several studies discussing what factors might predict sickness absence. However, to help us understand how a treatment works, for whom it works and under which conditions, a more specific focus on mediators as well as moderators within a study for reducing sick leave is needed.
One construct that would appear useful in understanding and facilitating RTW when CBT is implemented is self-efficacy. In short, self-efficacy is the belief that an individual has in his/her capacity to perform a specific behavior successfully. When applied to RTW, people with low self-efficacy would believe that they might fail to fulfill their work demands or work role. These efficacy cognitions are expected to be prominently present among those with mental health problems, as mental disorders often erode a positive self-concept by the very nature of the disorder. Lagerveld et al have developed a self-efficacy questionnaire specifically oriented to capture self-efficacy expectations regarding RTW and return-to-work self-efficacy for sick listed employees with mental health problem. RTW-SE has been proven a robust predictor of actual return to work, however if it also serves as a mediator of change remains to be explored.
Another intervention model with some support for increased RTW is the inclusion of a workplace intervention (WI) in a rehabilitation program. In a Dutch RCT, Blonk et al compared CBT performed by trained therapists with treatment by "labor experts" who had had a brief instruction in CBT principles, with controls. They found a significantly better RTW in the labor expert group compared to CBT, which did not differ from the controls. In a Swedish study, a manualized WI was evaluated and found significantly better compared to (non-randomized) controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Employment grade at 50% minimum. On Sick-leva for at least 1-12 moths due to adjustment, anxiety or depressive disorders.
排除标准
- •Patients with addiction disorders, schizophrenia, psychotic disorders high suicidal risk, bipolar disorder, severe depression or generalized anxiety disorder. Patients on current psychotherapy. Patients that do not speak and write Swedish.
研究组 & 干预措施
ACT
The ACT intervention consists of 6 manual-based face-to-face sessions and internet-based homework modules. The manual is based on the six core processes in the ACT-model: acceptance, mindfulness, defusion, self as context, values and committed action.
干预措施: Acceptance and Commitment Therapy (ACT) (Other)
WPI
This interventions aims at the facilitation of dialogue between the participant and the workplace through a series of steps consisting of individual interviews with the participant and his/her nearest supervisor and a so called "convergence dialogue meeting" in order to agree upon short- and long-term solutions.
干预措施: workplace intervention (WPI) (Other)
ACT and WPI
The study participants receive both ACT and WPI. The ACT intervention consists of 6 manual-based face-to-face sessions and internet-based homework modules. The manual is based on the six core processes in the ACT-model: acceptance, mindfulness, defusion, self as context, values and committed action. WPI aims at the facilitation of dialogue between the participant and the workplace through a series of steps consisting of individual interviews with the participant and his/her nearest supervisor and a so called "convergence dialogue meeting" in order to agree upon short- and long-term solutions.
干预措施: Acceptance and Commitment Therapy (ACT) (Other)
ACT and WPI
The study participants receive both ACT and WPI. The ACT intervention consists of 6 manual-based face-to-face sessions and internet-based homework modules. The manual is based on the six core processes in the ACT-model: acceptance, mindfulness, defusion, self as context, values and committed action. WPI aims at the facilitation of dialogue between the participant and the workplace through a series of steps consisting of individual interviews with the participant and his/her nearest supervisor and a so called "convergence dialogue meeting" in order to agree upon short- and long-term solutions.
干预措施: workplace intervention (WPI) (Other)
Control group
Treatment as usual (TAU) which means that the participant continues in ordinary health care and does not receive interventions other than the initial assessment.
结局指标
主要结局
Return to work
时间窗: at 6, 12, 24 and 60 months
Primary outcome measure is RTW based on register data on number of sick leave days from the National Insurance Office (NIO), self-reported data regarding short-term absence (periods of less than 14 days, that is not registered at NIO) and self-reported work ability according to scores in the Work Ability Index (WAI). The primary outcome will be reported as change over time from inclusion and at 6, 12, 24 and 60 months.
次要结局
- Changes in symptom severity of depression(at 6, 12, 24 and 60 months)
- Changes in symptom severity of anxiety(at 6, 12, 24 and 60 months)
- Changes in score of burnout symptoms(at 6, 12, 24 and 60 months)
- Changes in scores of General function(at 6, 12, 24 and 60 months)
- Changes in scores of general satisfaction with life(at 6, 12, 24 and 60 months)
研究者
Anna Nager
MD, PhD
Karolinska Institutet
