The effect of individual enabling and support on empowerment and depression severity in persons with affective disorders: outcome of a randomized control trial

Purpose: To evaluate the effect of Individual Enabling and Support (IES) on empowerment and depression severity as compared to Traditional Vocational Rehabilitation (TVR) in people with affective disorders at 12 months follow-up. Additionally, longitudinal changes within the intervention groups and the correlation over time between empowerment and depression severity were evaluated. Method: A single-blind randomized controlled trial of two intervention groups, IES (n = 33) and TVR (n = 28), was performed with measurement points at baseline, 6, and 12 months. Individuals with affective disorders, including depression and bipolar disorder diagnoses were included. The Empowerment Scale and Montgomery-Åsberg Depression Self-Rating Scale were administered, and Intention-To-Treat analysis was applied. The study was registered with the trial number ISRCTN93470551. Result: There was a statistically significant difference between the intervention groups on empowerment and depression severity at 12 months. Within-group analysis showed that IES-participants increased their perceived empowerment and decreased their depression severity between measurement points, this was not seen among TVR-participants. A moderate, inverse relationship was detected between empowerment and depression. Conclusion: IES is more effective in increasing empowerment and decreasing depression severity after a 12-month intervention than is TVR. This study was limited by a small sample size and larger trials in different contexts are needed.

Depression; bipolar disorder; supported employment; vocational rehabilitation; return-to-work

Depression is among the largest single cause of disability worldwide, and results in extended periods of sick-leave [[1] ,[2] ]. Depression causes distress and impairment [[3] ], along with substantial economic disadvantage for individuals. For employers, it manifests itself in high rates of sickness absence and productivity losses [[2] ]. Society suffers a substantial financial burden from high sick-leave rates [[NaN] ], and this burden has grown continuously in recent years [[4] ]. The magnitude of the sick-leave problem is clear, and effective return-to-work (RTW) interventions are needed to support getting individuals with depression back to work [[7] ].

Depression can be divided into different levels depending on the severity, amount, and duration of symptoms [[8] ], and can affect an individual in many activities of daily life and work [[7] ]. The focus of this study is on the RTW-process among individuals with affective disorders such as depression or bipolar disorders. These disorders are studied together since individuals with bipolar disorder can experience their depressive episodes as more disabling for work capacity than are the manic periods [[9] ,[10] ].

Empowerment is a multidimensional construct and reflects processes on individual, group and community levels. On the individual level, empowerment means increasing autonomy, overcoming powerlessness, and gaining control over one’s life [[11] ,[12] ]. WHO defines empowerment in mental health as the users’ level of influence, choice, and control of the mental health services [[11] ]. Empowerment is an important factor associated with fewer severe depressive symptoms and higher quality of life [[13] ] among people with severe mental illness who return to work [[14] ].

Historically, individuals with mental health problems have been excluded from decision-making regarding their mental health services [[15] ]. Powerlessness, manifest as lack of influence or control, can lead to poor health outcomes. Conversely, empowerment can lead to positive outcomes that include increased emotional well-being, independence, and increased coping strategies [[11] ]. The term ‘recovery’ in mental illness has two definitions: clinical and personal recovery [[16] ]. Personal recovery can be achieved even though symptoms persist, when the person creates a life that is meaningful for them despite their mental illness. Clinical recovery is achieved when symptoms of the mental illness resolve [[17] ].

This study considers two RTW approaches: Traditional Vocational Rehabilitation (TVR) and Individual Enabling and Support (IES). TVR is based on the train-then-place model [[18] ] and originates from a medical perspective where individuals are first submitted to treatment and prevocational training related to their clinical recovery. After vocational training, employment is the final step [[14] ,[19] ]. In contrast, IES refers to a place-then-train model and builds on personal recovery. Resources are available, and job placements are prompt and aligned with preferences. IES is based on the evidence-based supported employment approach of Individual Placement Support (IPS) for individuals with psychosis [[20] ]. However, motivational, cognitive, and time-use support strategies better support the needs of the target group. IES is far more effective than TVR regarding employment [[21] ], but understanding of non-vocational outcomes such as empowerment and depression severity is lacking.

The aim was to examine the effectiveness of IES in terms of empowerment and depression severity, data were collected as secondary outcomes in a registered trial ISRCTN93470551 [[21] ]. We hypothesized that IES-participant perceptions of empowerment would increase, and their depressive symptoms would decrease and that there would be a difference between groups at 12 months. The aims were to evaluate:

The effect of IES versus TVR on empowerment and depression after 12 months in people with affective disorders.

Longitudinal changes of empowerment and depression severity within each treatment group.

The correlation between empowerment and depression across the measurement time points.

This study is part of a parallel, randomized controlled trial (RCT) of individuals with affective disorders who are participating in IES or TVR (N = 61). The primary outcome was employment rate at 12 months, while the secondary focus was on other vocational outcomes [[21] ], and in the present study, mental health outcomes of empowerment and depression. The RCT lasted 12 months, began in December 2011, and ended 2.5 years later [[21] ]. The RCT followed CONSORT guidelines for non-pharmacological interventions [[22] ], with a trial number register ISRCTN93470551.

Individuals from four geographically diverse outpatient settings within the Mental Health Service (MHS) in Scania County in Southern Sweden were recruited. Inclusion criteria for the target group were depressive episode (ICD-10 F32), recurrent depression (F33, F33.1), or bipolar disorder (F31, F30) including depressive episodes. Diagnoses were set by the team psychiatrist according to the International Classification of Diseases 10th edition [[23] ]. Participants were aged 18-63 years, able to communicate in Swedish, had expressed an interest in employment, had not been employed during the past year, received MHS treatment, and attended a research information meeting. Exclusion criteria included severe drug or alcohol abuse, and somatic illness or physical disability that could impact participation and vocational outcomes. Potential participants were recruited by several channels: leaflets in the waiting room, advertisements in the daily paper, or information on the project web page. They subsequently attended a research information meeting that occurred twice monthly at each location or received information individually. Information on the interventions, inclusion criteria, RCT design, randomization, and ethical issues were provided. Written consent was obtained from each study participant. Ethical approval was obtained from the Regional Ethical Review Board at Lund University, Lund, Sweden (Dnr 2011-544).

IES was developed for individuals with affective disorders in their RTW-process. IES includes 10 principles: handling change and developing motivational and cognitive strategies related to RTW-process, having a time-use pattern that supports work-life balance, integration of vocational approaches with mental health, competitive employment as a primary goal, eligibility based on client choice, rapid job search, job search based on personal preferences, ongoing support and work accommodations as needed, benefit counseling (Social Insurance Agency/Public Employment Service) at an early stage, and systematic recruitment and quality engagement with employers. The following phases are also involved: (1) enabling motivational, cognitive, and lifestyle strategies, (2) completion of a career profile and plan, (3) job-seeking, and (4) supported employment. Phases 1 and 2 last for 1-2 months, phase 3 continues until employment is reached, and phase 4 involves support at work. The duration of phases 1, 2, and 3 is approximately 1 h per week, while phase 4 requires 20 min per week. IES is delivered by an Employment Specialist who works with the individual in relation to the Mental Health Service (MHS), Social Insurance Agency (SIA), Public Employment Service (PES), employers, and family. The Employment Specialists had clinical experience in supporting individuals with affective disorders. Before this project, they underwent a three-week long training in motivational interviewing from a certified motivational interviewer, cognitive strategies from a cognitive behavioral therapy psychologist, and ‘time-for-work’ strategies from an occupational therapist. The training was reinforced through face-to-face supervision throughout the intervention period, and addressed IES program fidelity [[21] ].

The TVR intervention includes services from various professionals and organizations, for example, MHS, the municipality, SIA, and PES. This approach is individualized to a lesser extent and is delivered in several assessment stages. Step one involves the MHS working to reduce symptoms in order to increase work ability (1 h per week). Step two is performed by the SIA and PES and involves assessment of the individual at 50% work capacity (10-20 h per week). The individual is encouraged to enter Step 3, prevocational activities at the municipality, if work capacity is not reached. Step 3 is regulated by law to be 5-20 h per week. The last step is vocational training through internship placements (20-40 h per week) with support from the PES, and may lead to employment [[24] ].

Participants’ sociodemographic, clinical characteristics, and comorbidity were measured at baseline (T1). Empowerment and depression severity were measured at three points: baseline, (T1), 6 months (T2), and 12 months (T3). To standardize data collection, two research assistants with extensive experience of the target group and instrument use were recruited and underwent a three-day training course. Data collection took place at the MHS centers and lasted for approximately 2 h at baseline and 1 h at follow-up. Great importance was placed on creating a calm environment for data collection [[21] ].

One questionnaire was used to collect sociodemographic and clinical data. Comorbidity was collected using three other assessment instruments. The Adult ADHD Self-Report Scale (ASRS) is a self-reported screening tool to address adult attention and hyperactivity disorder. The ASRS consists of 18 items distributed equally into two groups: inattention and hyperactivity-impulsivity. Individuals grade themselves on a 5-point rating scale (0-4). The sum score ranges from 0 to 72 and a score over 24 indicates a higher chance of ADHD [[25] ]. The Alcohol Use Disorders Identification Test (AUDIT) addresses hazardous drinking habits [[26] ] and consists of 10 questions. Scores are between 0 and 4, with a maximum sum score of 40. The cutoff score was set at >6 for women and >8 for men [[27] ]. The Karolinska Exhaustion Disorder Scale (KEDS) is a self-rated screening tool for assessment of symptoms of stress and exhaustion. The nine items address concentration, memory, physical stamina, mental stamina, recovery, sleep, hypersensitivity to sensory impressions, experience of demands, and irritation/anger. Each item has a 7-point scale (0-6) with a highest summary score of 54 points. A cutoff score of ≥19 points discriminates the presence of exhaustion disorder [[28] ].

Empowerment was measured using the Empowerment Scale (ES) developed by Rogers et al. [[29] ]. The ES includes 28 statements and five subscales: self-esteem/self-efficacy, power/powerlessness, community activism and autonomy, optimism and control over the future, and righteous anger. Individuals grade themselves from 1 (strongly agree) to 4 (strongly disagree), with a range of 28-112 total points. A higher score indicates a greater perception of empowerment. The Swedish version has good internal consistency [[30] ]. Cronbach’s alpha values for the present trial were satisfactory: T1 = 0.792, T2 = 0.872, and T3 = 0.872.

Depression was assessed by the self-rated Montgomery-Åsberg Depression Rating Scale (MADRS-S) [[31] ]. The scale consists of nine items: mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, motivational involvement, pessimism, and zest for life. Each is rated on a 7-point scale (0-6). The sum score ranges from 0 to 54, and is categorized as no or hardly any depression (0-12), less severe depression (13-19), moderate depression (20-34), and severe depression (≥35). MADRS-S has satisfactory construct validity, internal consistency, reliability, and sensitivity to change [[32] ]. Cronbach’s alpha values were satisfactory: T1 = 0.839, T2 = 0.888, and T3 = 0.907.

With a significance level set at.05 and a power of 0.80, the needed sample size ranged from 11 to 42 participants per group [[NaN] ]. RCT-groups of 60 individuals per group were considered large enough to allowing for a 30% attrition rate, which is consistent with previous research on psychosis where lost to follow-up was 28% [[36] ]. The power calculation in the RCT project was made on the primary outcome of the RCT, that is, employment rate at 12 months [[21] ]. The results revealed a mean difference between intervention groups of 38%, with a moderate effect size. No power calculation was thus made on the secondary outcomes of other vocational outcomes, and empowerment and depression [[21] ]. Originally, one large catchment area was targeted for successful logistics and recruitment. However, a decision was made by the division of MHS and project steering committee to choose four geographically diverse mid-size cities and outpatient teams instead, since other ongoing projects had started since the planning of the trial. Additional locations could not be included because of logistical problems with IES delivery. Participants were randomized by an independent researcher at Lund University who was not involved in the recruitment process or delivery of the intervention. The randomization plan had a block size of eight allocation numbers at a time [[37] ]. The categorization was masked until after randomization and participants received a confirmation letter. The trial was single-blinded to the assessor blinded, that is, the researcher did not have knowledge prior of the allocation of the participants or their identity and all data were coded. Allocation status could not be blinded for participants or those delivering the interventions.

Chi2-tests were used to evaluate sociodemographic and clinical variables. Student’s t-tests were used to evaluate continuous variables. Mann-Whitney U-tests were applied to investigate differences between interventions groups at baseline, 6 months, and 12 months. The Wilcoxon signed rank test was used to analyze empowerment and depression severity between measuring points within each group. Effect size coefficients of variation (r) were calculated for non-parametric data [[38] ], and interpreted using Cohen’s criteria (0.10 = small, 0.30 = medium, 0.50 = large) [[39] ]. Spearman’s rank test was applied for correlational statistics. Values were measured, and 1 or −1 indicated a perfect correlation, and zero indicated no correlation. The principle of Intention-To-Treat (ITT) was used [[22] ,[40] ]. For missing data, the imputation principles were used of the last observation carried forward (LOCF) or the next observation was carried backward (NOCB) [[41] ]. Supplementary analyzes on primary data, that is, before imputations, were performed. A binary logistic regression analysis was applied to investigate if the empowerment and depression scores affected the RTW outcome, that is, employment or not, at 12 months. The dichotomous variable of RTW was the dependent variable, and empowerment and depression were the independent variables. Statistical analyzes were performed using SPSS version 23 (SPSS Inc., SPSS Armonk, NY. Released 2015. SPSS for Windows, Version 23.0). A two-tailed p value of <.05 indicated statistical significance.

Figure 1 shows the trial profile from the beginning of the RCT when 77 individuals were assessed for eligibility, a total of 63 participants were randomized to IES (n = 33) and TVR (n = 28) interventions. The block-sized randomization plan had originally estimated 120 participants, and this explains the uneven distribution. No significant differences were found between groups at baseline except for age (p = .04) and use of alcohol (p = .03). No differences in baseline characteristics were found between those included in the analysis and those lost to follow-up [[21] ]. At T1, once IES-participant did not succeed in filling in the ES instrument (man, age =21, F31). At T2, one TVR-participant was lost to follow-up (female, age = 55, F32). At T3, two TVR-participants were lost to follow-up (female age = 46, F31 and female, age = 20, F32). Two IES-participants (female, age = 40, F32 and female age = 47, F32) had missing data for ES and MADRS-S at T3. Another IES-participant (man, age = 29, F32) had missing data only for ES also at T3. At baseline, no differences were found between imputed ITT material and primary data.

Baseline sociodemographic and clinical characteristics are presented in Table 1. Comorbidities are shown in Table 2.

Sociodemographic and clinical characteristics of the participants at baseline (N = 61).

1 aFrance n = 1, Vietnam n = 1, Denmark n = 2, South Korea n = 1.

Baseline comorbidity screening for exhaustion, attention disorder, and alcohol misuse among the participants.

• 2 SD: standard deviation; KEDS: Karolinska Exhaustion Disorder Scale; ASRS: Adult ADHD Self-Report Scale; AUDIT: Alcohol Use Disorders Identification Test.
• 3 aInattention.
• 4 bHyperactivity.

At T1, median empowerment scores were 75.0 for the IES and 71.5 for the TVR-groups and there was no difference between groups (p = .205, Z = −1.269, r = 0.162). At T2 follow-up, IES-participants’ empowerment scores increased by four points (Mdn = 79), while TVR-participants’ score increased by 0.5 points (Mdn = 72), with a close to significant difference between groups (p = .053, Z = −1.934, r = 0.248). At T3 follow-up, the difference between groups was significant (p = .004, Z = −2.913, r = 0.373). The IES-participants increased their median score by 1 point between T2 and T3 (Mdn = 80.0), but no increase occurred for the TVR-participants (Mdn= 72.0 at both T2 and T3).

At T1, the median MADRS-S score for IES was 22 and for TVR was 23.5 (difference: p = .132, Z = −1.507, r = 0.193). At T2, a difference was found between groups (p = .046, Z = −1.992, r = 0.255). IES-participants had less severe depression (Mdn = 17, 5-point decrease) and TVR-participants had moderate depression (Mdn = 22, 1.5-point decrease). At T3, the difference in depression was significant (p = .033, Z = −2.129, r = 0.273). The MADRS-S scores for IES-participants continued to decrease (Mdn = 15, 2-point decrease, less severe depression) and TVR-participants remained stable (Mdn = 22 at both T2 and T3). The difference in scores between groups was 7 points at 12-month follow-up.

Analysis of empowerment data (before imputation) showed a similar result to the ITT analysis. At T1, slightly lower p value was shown (p = .191), however the same at T2. At T3 a marginally lower difference was found (p = .009, Z = −2.615, r = 0.353; IES: n = 30, Mdn = 81; TVR: n = 25, Mdn = 72). For the MADRS-S score, primary and ITT analyzes were the same at T1. At T2 a greater difference was found between the primary data set (p = .067, Z = −1.830, r = 0.236; IES: n = 33, Mdn = 17; TVR: n = 27, Mdn = 22) and the ITT analysis (p = .046). At T3 the p value was almost the same (p = .032) as with the ITT (p = .033).

A logistic regression analysis at 12-month follow-up revealed that neither the empowerment (IES p = .681, TVR p = .955) nor the depression scores (IES p = .399, TVR p = .339) affected the outcome of RTW, that is, having employment or not.

An increase in perceived empowerment was seen for the IES-group between measurement points (T1-T2: p = .006, Z = −2.757, r = 0.339; T2-T3: p = .010, Z = −2.567, r = 0.316; T1-T3: p = .000, Z = −3.782, r = 0.466). The TVR-group also showed higher median scores over time, but these were not significant (T1-T2: p = .575, Z = −0.560, r = 0.075; T2-T3: p = .951, Z = −0.061, r = 0.008; T1-T3: p = .400, Z = −0.842, r = 0.113).

IES-participants showed a significant improvement in depression scores between T1-T2 (p = .011, Z = −2.543, r = 0.313) and T1-T3 (p = .004, Z = −2.901, r = 0.357), but not at T2-T3 (p = .341, Z = −0.953, r = 0.117). This suggests that the benefit was obtained by 6 months and then maintained for an additional 6 months. For the TVR-group, no difference was found between measurement points (T1-T2: p = .279, Z = −1.082, r = 0.145; T2-T3: p = .884, Z = −0.147, r = 0.020; T1-T3: p = .204, Z = −1.271, r = 0.170).

Analysis for empowerment was the same as ITT for IES-participants. Among participants receiving TVR, no differences were seen between the primary data set and ITT for any time point measurements. When analyzing depression scores, there were no differences for the IES-group with or without the imputation. There were no significant differences between any of the measurement points in the TVR-group.

Correlations between empowerment and depression were significant for the IES-group at all measuring points (T1: p = .003, rs = −0.498; T2: p = .000, rs = −0.735; T3: p = .000, rs = −0.700). The TVR-participants had a significant correlation at T3 (p = .000, rs = −0.624), but not at T1 (p = .056, rs = −0.365) or T2 (p = .098, rs = −0.319).

Differences between intervention groups existed at T3 for the subscales self-esteem/self-efficacy (p = .032, Z = −2.142, r = 0.274; IES: Mdn = 26, TVR: Mdn = 23), community activism and autonomy (p = .006, Z = −2.753, r = 0.352; IES: Mdn = 16, TVR: Mdn = 15), and optimism and control over the future (p = .001, Z = −3.263, r = 0.418; IES: Mdn = 12, TVR: Mdn = 10.5). A significant difference was seen between intervention groups for the MADRS-S subscale appetite (p = .006, Z = −2.728, r = 0.349, IES: Mdn = 0, TVR: Mdn = 2).

The primary focus of this study was the effectiveness of IES on empowerment and depression severity scores at 12 months follow-up. IES-participants demonstrated significantly higher levels of empowerment and lower levels of depression compared to those in TVR. The largest differences were seen in the empowerment sub-groups of self-esteem/self-efficacy, community activism and autonomy, and optimism and control over the future. Significant within-group changes in empowerment and depression scores were found in the IES-group, where moderate to strong negative correlations were seen between empowerment and depression. As the result showed, empowerment and depression did not influence gaining employment or not at 12 months. We therefore assume that the demonstration of the IES effects on mental health can be explained by the individualized and resource based support of enabling of motivational, cognitive, and time use strategies in combination with supported employment. Qualitative research tells us that IES builds on a supporting and power neutral relationship between the employment specialist and the patient and of continuous support that are provided throughout the intervention period of 12-months [[42] ]. IES enables and supports an individual’s own resources, interests, and preferences, provides hope and power, relies on professionals’ positive attitudes, beliefs, and behaviors about mental illness and work, and employs a holistic approach in which mental health and vocational service are integrated to support personal recovery [[42] ,[43] ]. In TVR, most participants were patients in MHS, on sick-leave for approxiately 4 years, without integrated RTW support [[21] ]. Those TVR participants who took part in traditional support met an array of different professionals from the MHS, the employment service and insurance agency, however, with no one taking the lead or responsibility for the RTW-process. In addition, the focus is primarily on issues related to the illness and symptoms and on pre-vocational training [[36] ]. In the previous RCT study on the effectiveness of IES, a considerably higher rate of competitive employment was demonstrated for the IES group, as opposed to those in TVR after 12 months, 42.4% vs. 4%. [[21] ]. Notably, these results are in line with previous supported employment research on individuals with psychosis after 18 months follow-up (46% vs. 11%) [[36] ].

To understand the effect of IES on empowerment, it is important to consider the vulnerable position of individuals with affective disorders who are entering the RTW-process. This includes their experience of a range of losses, motivations, own and others’ belief in them and their capacity, these can negatively impact on their ability to work [[44] ]. Professionals can experience these individuals as having difficulty with time management, work duties, and emotional strain [[45] ]. The enabling IES-principles of motivational, cognitive and time use strategies seem especially important with this in mind. The Employment Specialist supports their clients in motivation, ability to handle time and changes, and strategies that mitigate negative thought patterns and avoidance behaviors [[43] ,[46] ]. These enabling and supported employment principles empower the individual to take control of decisions in their RTW-process [[21] ,[43] ]. The 12-month empowerment findings are consistent with previous research on supported employment and empowerment, where stigma also contributed to the understanding of empowerment [[14] ]. When returning to work while recovering from mental illness, it is important to experience control, support, and understanding [[43] ,[47] ]. In contrast, when empowering support is not present, lack of confidence in the RTW-process and work ability can become negative consequences [[11] ,[43] ,[47] ]. Mental health professionals in TVR have raised concerns that an individual’s lack of ability to make decisions can lead to a vicious circle of persistent dependency [[11] ]. Against the backdrop of such research results, we wish to stress the importance of empowering individuals to make their own decisions [[13] ,[14] ,[43] ,[48] ]. Empowered individuals are more likely to make active choices and actively engage in their RTW-process [[49] ].

The inverse relationship between empowerment and depression is in line with current and previous research [[11] ,[14] ,[50] ]. Empowerment and depression are two constructs and domains that may reflect each other. In our result, higher empowerment scores correlated with lower depression scores among the IES participants at both 6 and 12 months follow-ups. Previous research has also shown increased empowerment to impact on quality of life [[13] ]. We believe that the clear increase of empowerment and simultaneous decrease of depression severity over time for the IES-participants are strongly connected to integrating cognitive strategies, that is, diminishing negative thought patterns and avoidance behaviors with supported employment. This is consistent with a previous Norwegian trial that showed a reduction in depressive symptoms when cognitive behavioral therapy was performed in connection with individual job support [[51] ]. Thus, supporting individuals in a way that positively reinforces their RTW-process is essential if there is to be an impact on depression [[42] ]. It was notable that the IES participants had already at 6 months moved from having moderate depression to less severe depression. At 12 months follow-up, their depression score further decreased. This effect was not seen among the TVR participants who, at all measuring points, displayed moderate depression.

A limitation was the uneven gender distribution. This probably reflects the greater proportion of women who are diagnosed with depression [[52] ,[53] ]. Another limitation includes that the sample size was smaller than intended. Thus, the results should be interpreted with caution. The power calculation was performed in relation to the primary outcome of employment rate in the previous RCT. It showed the need of 60 participants in each group, allowing for a 30% attrition rate [[21] ]. No power analysis was addressed in relation to the empowerment and depression scores. However, the results showed small to moderate R-values which indicate that, whilst the study had a small sample size, it was robust enough to demonstrate an effect between interventions. The internal validity with regard to the equivalence between groups at baseline, valid instrument usage, and controlling the fidelity or process of the experiment (interventions) are some factors that strengthened the quality of the RCT and thus the external validity [[54] ]. The generalizability may further be strengthened by the positive employment and mental health effect of supported employment in the present RCT context [[21] ], and supported employment research on psychosis in Sweden [[36] ], and in non-US contexts [[20] ]. Furthermore, few participants were lost to follow-up and few data were missing and our analyses and manuscript followed CONSORT guidelines for a randomized controlled trial. Further studies should include a larger sample size that is based on a statistical power calculated on the secondary outcomes of the RCT, and be performed in a primary health care context and include a larger group of immigrant participants which have increased in number in recent years but are often excluded from research due to language deficiency and for low mental health literacy. This, in turn, leads to low rates of help-seeking behaviors [[55] ].

Our results and previous research on IES so far [[13] ,[21] ,[43] ,[42] ] shows that IES has an important role to play for individuals with affective disorders in their RTW journey and personal recovery. Given the individual and society benefits, this approach should have a natural place in clinical practice.

The authors wish to thank the participants for their generous contributions to this study, the employment specialists, mental health services, research assistants; a REHSAM research grant for funding the trial; and the Medical Faculty at Lund University for funding this research.

The authors report no conflicts of interest.

PHOTO (COLOR): Figure 1. Trial profile.