Clinical Trial: Return to Work: Promoting Health and Productivity in Workers With Common Mental Disorders

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: SAFARI-Return to Work: Promoting Health and Productivity in Workers With Common Mental Disorders

Brief Summary: 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.

Detailed Summary:

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.

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Sponsor: Karolinska Institutet

Current Primary Outcome: Return to work [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in symptom severity of depression [ Time Frame: at 6, 12, 24 and 60 months ]
    Changes in scores of MADRS-S (Montgomery Åsberg Depression Rating Scale)and HAD - subscale Depression (Hospital Anxiety and Depression Scale),over time; at inclusion, 6, 12, 24 and 60 months.
  • Changes in symptom severity of anxiety [ Time Frame: at 6, 12, 24 and 60 months ]
    Changes in scores of anxiety are measured with HAD(Hospital Anxiety and Depression Scale) - anxiety subscale, over time; at inclusion, 6, 12, 24 and 60 months.
  • Changes in score of burnout symptoms [ Time Frame: at 6, 12, 24 and 60 months ]
    Changes in scores of burnout symptoms over time; at inclusion, 6, 12, 24 and 60 months, measured with Karolinska Exhaustion Disorder Scale(KEDS).
  • Changes in scores of General function [ Time Frame: at 6, 12, 24 and 60 months ]
    Changes in scores of General function over time; at inclusion, 6, 12, 24 and 60 months,measured by the Work and Social Adjustment Scale
  • Changes in scores of general satisfaction with life [ Time Frame: at 6, 12, 24 and 60 months ]
    Changes in scores of general satisfaction with life over time; at inclusion, 6, 12, 24 and 60 months, measured with the Satisfaction with life scale (SWLS).


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: February 19, 2013
Date Started: March 2013
Date Completion:
Last Updated: March 18, 2016
Last Verified: March 2016