Work-focused Versus Generic Internet-based Interventions for Stress-related Disorders
Condition: Adjustment Disorders
MeSH terms: Adjustment Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Studies suggest that stress can be managed through internet- and computer-based
      interventions. In a meta-analysis including 26 controlled studies (n=4226), small to moderate
      effects were found on outcomes on stress, depression and anxiety. Subgroup analyses revealed
      that guided interventions were more effective. Studies also suggest that internet-based
      interventions for stress can have sustained effects on stress reduction, be cost-effective,
      and have positive effects on participant's experiences on health and wellbeing in both work
      and private life. However, previous iCBT studies have focused on individuals with elevated
      stress and few studies has evaluated the efficacy of iCBT in clinical samples, such as
      employees with stress-related disorder. In addition, we found no previous studies evaluating
      the efficacy of internet-based and work-focused interventions on sickness absence and RTW.

      Purpose of the present study The aim of the current study was to evaluate the efficacy of
      iCBT for stress-related disorders integrating work-related aspects (W-iCBT) and a generic
      iCBT, compared to a waitlist control condition (WLC). We hypothesized that W-iCBT and iCBT
      would be superior and equally effective in reducing perceived stress, burnout, exhaustion,
      and improving recovery from work and quality of life, compared to a WLC. In secondary
      explorative analyses, we examined whether the W-iCBT would differ from the iCBT and WLC with
      regard to important work-related outcomes including work experience, work ability, sickness
      absence and long-term-sick-leave. We also hypothesized that initially achieved changes would
      remain stable at a 12-month follow-up.

      Method

      Design This study was a three-armed controlled superiority trial in which two internet-based
      interventions for stress-related disorder: (a) cognitive-behavioural therapy (iCBT) and (b)
      work-focused iCBT (W-iCBT) that integrated work aspects early into the treatment, were
      compared against a wait-list control group. The study followed the CONSORT guidelines. Sample
      size was estimated on the basis of previous controlled trials on iCBT for chronic stress,
      with the aim of detecting an medium effect size on the primary outcome Shirom-Melamed Burnout
      Questionnaire (see Measures), at post assessment, based on a power of 0.80 in a two-tailed
      test with 0.05 significant level. Self-reported outcome assessments were collected at pre-
      and post-treatment (ten weeks) and at a 6- and 12-month follow-up. Participants who met the
      study criteria and provided informed consent were randomly allocated by an independent
      researcher using an internet-based random generator (www.randomizer.org). The independent
      researcher received a list of anonymous identification numbers of all participants and
      coaches. This procedure ensured that blinding was implemented during randomization. All
      participants, coaches and those participants reporting benefits due to long-term sick leave
      at baseline, were randomized in a 1:1:1 proportion. The Ethical Committee of Linkoping
      University, Sweden, approved all procedures involved in the study (reference number
      2016/11-31).

      Procedure The study was conducted in a university setting, with researchers and the treatment
      platform hosted by the university. Participants were recruited from the general public
      through advertisement, articles in regional and national newspapers, and labour organization
      magazines. Detailed information and application to the study was presented on the project's
      homepage (www.istress.se). After initial registration using personal e-mail address,
      potential participants received an ID number and were asked to (i) provide written informed
      consent, (ii) complete online screening questionnaires (see Measures) and (iii) participate
      in a diagnostic interview over the telephone. Following the interview, the included
      participants were randomized. Participants of the iCBT and W-iCBT groups received access to
      the programs immediately after randomization and participants of the wait-list control group
      received access to iCBT/W-iCBT program after the six months follow-up.

      Support Every week, participants in both interventions (W-iCBT and iCBT) received
      personalized written messages from a coach with feedback on the exercises. For the
      participants in the W-iCBT group, guidance was given on the CBT and work-focused modules
      simultaneously. The coaches, eight in total, were master level psychology students who were
      specifically trained to perform feedback according to a standardized manual. The aim of the
      feedback was to provide support and encouragement and to monitor homework assignments and
      adherence to the intervention. Treatment as usual was not prohibited but also not encouraged
      during the trial. The coaches were requested to minimize their support to one message and 15
      min of correspondence per week and participant.

      Statistical analysis All analysis followed the Consolidated Standards of Reporting Trials
      (CONSORT) statement for randomized controlled trials. Statistical analyses were conducted
      following the intention-to-treat principle (ITT) using SPSS version 26. We used the multiple
      imputation (MI) procedure to impute missing sum scores for participants who did not complete
      the post- or six months follow-up assessments. MI is considered a to be a conservative
      approach for analysing incomplete datasets as it takes into account the uncertainty due to
      missing information. We used all available data from the pre-, post and six-months follow-up
      assessment as well as age, gender and educational level as predictors. Means, standard
      deviations, and standard errors of effect sizes were pooled from five sets of imputations.
      The effects of group on primary and secondary outcome measures of the ITT and completers-only
      datasets were analysed using repeated measures ANOVAs with time (pre, post and six-months
      follow-up) as a within-subject factor. Pooled F-values were calculated using RStudio. Cohen's
      d was reported for the between-group effect sizes and corresponding 95% confidence intervals
      (95% CI). Analysis of outcomes at baseline and demographical variables between complete and
      missing data were analysed using T- and Chi2-tests. Completers data on sickness absence and
      long-term sick leave were analysed using Kruskal-Wallis-test, non-parametric test recommended
      for comparison of three or more samples. To evaluate clinically significant change, we used
      the guidelines by Jacobson and Truax (1991). Clinically significant change was based on the
      completer's analysis. To meet the criteria for clinically significant change on the primary
      outcome SMBQ, participants had to demonstrate a reliable change of 0.69 and score under the
      cut-off of 4.4, in accordance with a recent study in a clinical sample by van de Leur et al.
      (2020). We completed the clinically significant change analysis with KEDS. On the KEDS,
      participants had to demonstrate a reliable change of 8.72 and score under the cut off of 19.
    

Intervention name(s): Internet-based Cognitive-behavioural therapy; Work-focused Cognitive-behavioural therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Internet-based Cognitive-behavioural therapy protocol was based on contemporary CBT techniques adapted for adjustment disorders, and recovery from work training inspired by Hahn et al. [50]. The iCBT program consisted of ten modules distributed over ten weeks, with modules lasting 60-120 min per week.; The Work-focused Cognitive-behavioural therapy consisted of the exact generic iCBT-modules included in the first experimental group and of additional work-focused modules adapted for adjustment disorders. The W-iCBT added about 2-3 regular pages compared to the generic iCBT.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a three-armed controlled superiority trial in which two internet-based interventions for stress-related disorder: (a) cognitive-behavioural therapy (iCBT; n=61) and (b) work-focused iCBT (W-iCBT; n=61) that integrated work aspects early into the treatment, were compared against a wait-list control group (n=60). The study followed the CONSORT guidelines [45]. Sample size was estimated on the basis of previous controlled trials on iCBT for chronic stress (e.g., Persson Asplund et al., 2018), with the aim of detecting an effect size of Cohens'd=0.50 on the primary outcome Shirom-Melamed Burnout Questionnaire (see Measures), at post assessment, based on a power of 0.80 in a two-tailed test with 0.05 significant level. Self-reported outcome assessments were collected at pre- and post-treatment (ten weeks) and at a 6- and 12-month follow-up.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stress; Burnout; Exhaustion; Work-focused; Internet-based; Sickness absence