Return to Work: Promoting Health and Productivity in Workers With Common Mental Disorders
Condition: Adjustment Disorders; Anxiety Disorders; Depression
MeSH terms: Anxiety Disorders; Mental Disorders; Psychotic Disorders; Adjustment Disorders
Study type: Interventional

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 description: 
      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.

      A third method that is interesting in relation to RTW due to its primary focus on improved
      function rather than symptom reduction is the CBT-method, Acceptance and Commitment Therapy
      (ACT). According to the theoretical frame of ACT, psychological discomfort is the result of
      experiential avoidance. Experiential avoidance implies attempts of avoiding painful thoughts,
      emotions and physical sensations even when these attempts counteracts effective behavior in
      terms of living in accordance with personal values. High levels of experiential avoidance
      have been associated with psychopathology including depression, anxiety and low quality of
      life. The clinical goal in ACT is to reduce experiential avoidance and instead enhance
      psychological flexibility which implies the development of a broader and more flexible
      behavior in accordance with personal values, also in the presence of negative stimuli.
      Several studies have shown that a general measure of this psychological process predicts a
      wide-range of work-related outcomes, from mental health and work attitudes to job performance
      and absence rates. A side effect of living a more functional life is often that self-reported
      psychological symptoms decline. According to ACT theory, psychological flexibility would be
      the key process of change, however there is no data available in the present to support this
      statement in relation to RTW.

      The duration of sick leave is also influenced by many other factors such as
      socio-demographic, medical, work-related and organizational factors, as well as by factors in
      the health-care and legislative systems. Diagnosis such as burnout, depression and anxiety
      disorders are associated with an increased risk of long-term sickness absence. Previous
      sickness absence increases the risk for long-term sickness absence also after adjustment for
      socio-demographic factors and self-reported health status. This may imply that short-term
      sickness absence has social and health-related consequences beyond the effects of the ill
      health it reflects. However, these findings may be further explored by taking severity of
      diagnosis into account, and need to be evaluated in a comprehensive study.

      Based on the above summary on current knowledge, the primary aims of the present study is to
      evaluate the efficacy of two different interventions, ACT and a workplace intervention (WPI),
      both as standalone treatments and combined, and compare these to TAU. The second aim is to
      examine different variables that moderate program efficacy and mediates change in RTW for the
      different interventions. The third aim is to evaluate cost-effectiveness.

      General research questions in this project includes

        1. What is the efficacy and cost-effectiveness of two different rehabilitation models, one
           based on psychotherapy, ACT, and the other on workplace-interventions, WPI , when these
           are offered as standalone interventions and in combination for patients with adjustment,
           anxiety and depressive disorders?

        2. Examination of mediators and moderators that might explain differences in RTW for
           individuals with common mental disorders participating in rehabilitation interventions?

        3. Does actual use of prescribed selective serotonin re-uptake inhibitors (SSRI) or
           Serotonin-norepinephrine reuptake inhibitors (SNRI) increase RTW compared to non-use of
           prescribed SSRI or SNRI among patients with adjustment, anxiety and depressive
           disorders? Methods The study is an RCT with repeated measures and a mixed design.
           Measures are taken at pre- and post-treatment and at 6, 12, 24 and 60 months follow-up.
           Participants are recruited from the National Insurance Office (NIO) starting in February
           2013. Individuals ages 18-60 living in the county of Stockholm with at least 50%
           employment rate applying for sick pay due to common mental disorders are consecutively
           invited to an diagnostic interview and assessment during the inclusion period.
           Individuals that meet the inclusion criteria and gives informed consent are invited to
           participate. A power analysis based on a study on the WPI by Björn Karlsson gives that
           in order to get 80 % power, 72 participants is required in each group. 320 participants
           will be randomized to one of 4 groups.

      The interventions:

        1. 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.

        2. 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.

        3. ACT + WPI; In this group, the participants will collaterally receive the ACT and the WPI
           intervention.

        4. 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.

      Independent variables:

        1. Consists of the within-group variable Time with five measurement points: pre-, and post
           treatment, 6, 12, 24 and 60 months.

        2. Consists of the between-groups variable Treatment condition with four conditions as
           described above.

        3. Consists of the between-groups variable Use or non-use of prescribed SSRI or SNRI
           reported by the patients in a questionnaire.

      Dependent variables Primary outcome measure is RTW based on register data from the NIO,
      self-reported data regarding short-term absence (periods of less than 14 days) and
      self-reported work ability according to the Work Ability Index (WAI).

      Secondary outcome measures are symptom severity and general function. Depression is measured
      with MADRS-S (Montgomery Åsberg Depression Rating Scale) and HAD - subscale Depression
      (Hospital Anxiety and Depression Scale), anxiety with HAD - subscale Anxiety, Burnout
      symptoms with Karolinska Exhaustion Disorder Scale (KEDS). General function as measured by
      the Work and Social Adjustment Scale and general satisfaction with life with the Satisfaction
      with life scale (SWLS).

      Measures of mediators will be taken in connection with treatment sessions and include: the
      Return To Work Self Efficacy scale (RTW-SE), The work-related acceptance and action
      questionnaire (WAAQ) and Bull´s Eye Values Survey (BEVS).

      Measures of moderators include: demographic data, sick days in the past five years, pre
      scores on self-rated symptoms (MADRS-S, HAD, KEDS).

      Statistical analyses Efficacy will be assessed with Mixed models for repeated measures. Mixed
      regression models are a powerful way to conduct an intent-to-treat analysis. Unlike normal
      analysis of variance/analysis of covariance, these models use all available data from all
      participants and take into account the obtained outcome and missing data. Mediational
      analyses will be based on Baron & Kenny´s requirements for testing mediation.
      Cost-effectiveness are based on a combination of cost-effectiveness analyses and
      cost-utility-analyses according to the Manual for Assessment of Cost-effectiveness-analysis
      in REHSAM based on contemporary guidelines in health economic science practice.

      This research provides an opportunity to better understand the process of RTW for individuals
      on sick-absence due to common mental disorders. A theoretical understanding of the mechanisms
      behind treatment change, which may differ for different subgroups, is important to ultimately
      be able to maximize or change treatments for individuals on sick-leave. This study might
      significantly contribute to answer real everyday questions that clinicians face as well as
      policy makers and agencies working with the task to increase RTW and promote public health
    

Intervention name(s): Acceptance and Commitment Therapy (ACT); workplace intervention (WPI)
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment