Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01805583 |
| Other study ID # |
2012/2109-31/5 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
February 19, 2013 |
| Last updated |
August 7, 2014 |
| Start date |
March 2013 |
| Est. completion date |
May 2019 |
Study information
| Verified date |
August 2014 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Sweden: The National Board of Health and Welfare |
| Study type |
Interventional
|
Clinical Trial 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.
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
