Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression in Denmark (the Danish IBBIS Study): A Multi-center Randomized Controlled Trial
Phase: NA
Conditions: Generalized Anxiety, Social Phobia, Panic Disorder, Depression
Sponsor: Amager Hospital

IBBIS Protocol (English version) 
0 
 
 
Version 3.1: July 5th 2019 
 
Regional Ethics committee: H-16015724 
 
ClinicalTrials.gov identifier:  
RCT 1: NCT02872051  
RCT 2: NCT02885519 
Study Protocol: Integrated mental health care and 
vocational rehabilitation to improve return to work 
rates for people on sick leave because of common 
mental disorders (IBBIS) 
 
Protocol template by Copenhagen Trial Unit aligned with the SPIRIT statement 
 
Authors: Rie Poulsen, Andreas Hoff, Jonas Peter Fisker, Esther Sorgenfrei 
Blom, Carsten Hjorthøj and Lene Falgaard Eplov 

IBBIS Protocol (English version) 
1 
 
Author details: 
Rie Mandrup Poulsen, PhD student (correnspondence author) 
Copenhagen Research Center for Mental Health – CORE, Mental Health Center Copenhagen, 
Copenhagen University Hospital 
Mail: rie.poulsen@regionh.dk 
Mobil: (+45) 2325 8879 
 
Andreas Hoff, PhD student 
Copenhagen Research Center for Mental Health – CORE, Mental Health Center Copenhagen, 
Copenhagen University Hospital 
Mail: andreas.hoff@regionh.dk 
Mobil: (+45) 6168 6131 
 
Jonas Peter Fisker, PhD student 
Copenhagen Research Center for Mental Health – CORE, Mental Health Center Copenhagen, 
Copenhagen University Hospital 
Mail: Jonas.Fisker@regionh.dk 
Mobil: (+45) 2335 8619 
 
Esther Sorgenfrei Blom, Psychologist 
Mail: esther.sorgenfrei.blom@regionh.dk 
Mobil: (+45) 5388 2018 
 
Carten Hjorthøj, Senior researcher 
Copenhagen Research Center for Mental Health – CORE, Mental Health Center Copenhagen, 
Copenhagen University Hospital 
Mail: carsten.hjorthoej@regionh.dk 
Mobil: (+45) 2613 6290 
 
Lene Falgaard Eplov, MD, PhD, Research senior consultant 
Copenhagen Research Center for Mental Health – CORE, Mental Health Center Copenhagen, 
Copenhagen University Hospital 
Mail: Lene.Falgaard.Eplov@regionh.dk 
Phone: (+45) 3864 7461  
Mobil: (+45) 2018 4687 
 
 
 
 
 

 
2 
 
ABSTRACT 
Background: Mental illness has an estimated financial burden on the Danish economy of 3, 4 
percent of the Danish GDP. Common mental disorders cause the largest financial burden because 
of the high prevalence and long-term sick leave. Furthermore, unemployment is also a risk factor 
for poor mental health. Thus, it is crucial to help people on sick leave due to common mental 
disorders return to work and reduce the risk of prolonged sickness absence. People on sick leave 
need help from various actors in the process of returning to work: health care providers, vocational 
rehabilitation services, the work place and often relatives are important. The IBBIS1 intervention is 
designed to provide coherent and coordinated mental health care and vocational rehabilitation 
services that improve the process of returning to work. The integrated intervention is provided by a 
community-based, multi-disciplinary team. 
 
The IBBIS project consists of 6 studies. Two RCT studies assess if an integrated mental health care 
and vocational rehabilitation intervention for recipients of sick leave benefit with common mental 
disorders help people return to work faster than services as usual. The Mental Health Assessment 
study examines the effect on vocational status after IBBIS mental health assessment, compared to 
standard GP assessment. The Process Evaluation study aims to evaluate the implementation of 
selected processes in the IBBIS interventions. The Cost-effectiveness Study provides an economic 
cost-effectiveness evaluation of the IBBIS intervention. The Predictors of return to work Study 
aims to examine factors at baseline, which predicts return to work.  
 
Methods: The RCT studies are designed as two three-armed investigator-initiated multi-centre 
parallel superiority trials: RCT 1 for people with generalized anxiety disorder, panic disorder, social 
phobia or depression, and RCT 2 for people with stress-related disorders. The three-armed RCTs 
are set up to compare the effectiveness of 1) standard mental health care and vocational 
rehabilitation services, 2) IBBIS stepped mental health care and standard vocational rehabilitation 
3) IBBIS integrated mental health care and vocational rehabilitation. The primary outcome is the 
return to work rate at 12 months, and secondary outcome measures are disease severity, work 
proportion, recurrent sickness absence, work- and social functioning. Eligible participants are 
people on sick leave for minimum four weeks because of depression, anxiety, distress, adjustment 
disorder, exhaustion disorder in Denmark. Participants will be recruited from Danish vocational 
rehabilitation centres (Jobcenters) in four municipalities from April 1st 2016 to March 31 2018. A 
total of 594 participants will be included into each RCT.  
 
In The Mental Health Assessment study, an intervention cohort, consisting of those who have been 
assessed by the IBBIS team but who do not receive IBBIS treatment, is compared to a control 
cohort, consisting of people eligible for referral to IBBIS assessment but who is not offered this. 
The process evaluation study will address the implementation of two core elements from the IBBIS 
intervention: 1) Integration of services through relational coordination between professionals in 
the IBBIS team 2) Participant involvement through shared decision-making at the round-table 
meetings. The Cost-effectiveness study calculates the cost-effectiveness of the IBBIS interventions 
compared to standard interventions using a standard cost-benefit formula. The Predictors of 
return to work Study consists of a structured literature review on predictors of return to work, and 
an analysis of predictors of return to work in the IBBIS sample. 
 
 
Discussion: The studies will contribute with knowledge about the effect and implementation of 
integrated vocational and health care interventions, and prevention of recurrent sickness absence 
among people with depression, anxiety and stress related disorders in a Scandinavian context. If 
                                                        
1 Da.: ”Integreret Beskæftigelses- og BehandlingsIndsats til Sygedagpengemodtagere” 

 
3 
 
the effect on return to work is improved with the new interventions, this study can contribute with 
new knowledge on shared care models between health care and vocational rehabilitation services in 
a Scandinavian Welfare system. 
 
 

 
4 
 
DANISH BSTRACT 
 
(this pdf document is rendered for upload on clinicaltrials.org, where only English language is 
allowed – the version with Danish abstract can be collected through corresponding with the 
authors or by following this link). 
 
 

 
5 
 
 
 

 
6 
 
TABLE OF CONTENTS 
Trial flow chart ..................................................................................................................................... 9 
Administrative information ............................................................................................................... 10 
Sponsor .............................................................................................................................................. 10 
Trial sites ............................................................................................................................................ 10 
Investigators ....................................................................................................................................... 11 
Project organisation ............................................................................................................................ 11 
List of abbreviations........................................................................................................................... 13 
1 
Introduction ................................................................................................................................ 14 
1.1 
Common mental disorders and sick leave ................................................................................ 14 
1.2 
Current practices in Mental Health Care and vocational rehabilitation .................................. 15 
2 
Aims and objectives .................................................................................................................... 17 
2.1 
Overall aim of the IBBIS project .............................................................................................. 17 
2.2 
Objectives ................................................................................................................................. 17 
2.2.1 
The mental health assessment study .............................................................................. 17 
2.2.2 
RCT 1: Anxiety and depression ....................................................................................... 17 
2.2.3 
RCT 2: Stress-related Disorders ..................................................................................... 17 
2.2.4 
Process evaluation study ................................................................................................. 18 
2.2.5 
Cost-effectiveness study .................................................................................................. 18 
2.2.6 
Predictors for return to work study ................................................................................ 18 
3 
Interventions .............................................................................................................................. 19 
3.1 
Background ............................................................................................................................... 19 
3.1.1 
Study Intervention .......................................................................................................... 20 
3.2 
Standard Mental health care and vocational rehabilitation ..................................................... 21 
3.2.1 
Standard Mental health care ........................................................................................... 22 
3.2.2 
Standard vocational rehabilitation ................................................................................. 23 
3.3 
IBBIS interventions .................................................................................................................. 23 
3.3.1 
The IBBIS team ............................................................................................................... 24 
3.3.2 
The Mental Health  assessment ...................................................................................... 25 
3.3.3 
Mental Health Care Interventions .................................................................................. 26 
3.3.4 
The Vocational rehabilitation intervention .................................................................... 29 
3.3.5 
Integration of IBBIS interventions ................................................................................. 30 
3.4 
Fidelity and quality assessment................................................................................................ 30 

 
7 
 
4 
Study design................................................................................................................................ 31 
4.1 
The Mental Health Assessment study ...................................................................................... 31 
4.1.1 
Introduction .................................................................................................................... 31 
4.1.2 
Aims and objectives ........................................................................................................ 32 
4.1.3 
Participants ..................................................................................................................... 32 
4.1.4 
Assessment Procedure .................................................................................................... 32 
4.1.5 
Data analysis ................................................................................................................... 34 
4.1.6 
Outcomes ........................................................................................................................ 34 
4.1.7 
Power calculations .......................................................................................................... 34 
4.1.8 
Statistical Analyses .......................................................................................................... 35 
4.2 
Randomized controlled trials ................................................................................................... 35 
4.2.1 
Participants ..................................................................................................................... 37 
4.2.2 
Outcomes and data collection ......................................................................................... 38 
4.2.3 
Randomization ................................................................................................................ 44 
4.2.4 
Blinding ........................................................................................................................... 45 
4.2.5 
Data management ........................................................................................................... 45 
4.2.6 
Statistical methods .......................................................................................................... 47 
4.3 
Cost-effectiveness study ........................................................................................................... 50 
4.4 
Process evaluation study .......................................................................................................... 50 
4.4.1 
Introduction .................................................................................................................... 50 
4.4.2 
Method ............................................................................................................................ 51 
4.4.3 
Discussion ....................................................................................................................... 54 
4.5 
Predictors for return to work Study ......................................................................................... 54 
4.5.1 
Background ..................................................................................................................... 54 
4.5.2 
Methods........................................................................................................................... 54 
5 
Ethical considerations ................................................................................................................ 56 
5.1 
Competing interests.................................................................................................................. 56 
5.2 
Official approval ....................................................................................................................... 56 
5.3 
Participation ............................................................................................................................. 56 
5.3.1 
Withdrawal from the research studies ............................................................................ 57 
5.4 
Adverse effects from the IBBIS intervention............................................................................ 58 
5.5 
Ethical issues regarding the Mental health assessment study ................................................. 58 
5.6 
Ethical issues regarding The predictors of return to work study ............................................. 59 

 
8 
 
6 
Trial timeline, plan for publication, and dissemination ............................................................. 60 
7 
References ................................................................................................................................... 61 
 
 
 
 

 
9 
 
 
TRIAL FLOW CHART 
 
 
Figure 1: Trial flow Chart 
 

 
10 
 
ADMINISTRATIVE INFORMATION  
SPONSOR  
Mental Health Services (RHP, Da.: Region Hovedstadens Psykiatri) in the Capital Region of 
Denmark and the Danish Agency for Labour and Recruitment (STAR, Da.: Styrelsen for 
Arbejdsmarked og Rekruttering) have established a horizontal cooperation to conduct project 
IBBIS. The project is financed with DKK 38.102.321 by pool funds administrated by the Danish 
Agency for Labour and Recruitment. Furthermore, RHP and STAR have established collaboration 
with four municipalities in order to execute the trials.  
 
Contact Danish Agency for Labour and Recruitment (STAR): 
Thomas Gross Havsager 
Direct telephone: +45 72 21 77 74 
E-mail: tgh@star.dk  
 
TRIAL SITES  
Referrals and delivery of the IBBIS interventions will take place at Mental Health Center 
Copenhagen in RHP and in these four municipalities: 
 
• 
Copenhagen City Municipality 
• 
Gentofte Municipality 
• 
Gladsaxe Municipality  
• 
Municipality of Lyngby-Taarbæk 
 
  
 
 

 
11 
 
INVESTIGATORS 
• Lene Eplov,  MD, Ph.D., Research department of Mental health center Copenhagen, Mental Health 
Services - Capital Region of Denmark 
• E-mail: Lene.Falgaard.Eplov@regionh.dk
Principal investigator
• Andreas Hoff, MD, Ph.D. student, Research department of Mental health center Copenhagen, 
Mental Health Services - Capital Region of Denmark
• E-mail: andreas.hoff@regionh.dk
Investigator
• Jonas Fisker, Certified MSc in psychology, Ph.D. student, Research department of Mental health 
center Copenhagen, Mental Health Services - Capital Region of Denmark
• Email: Jonas.Fisker@regionh.dk
Investigator
• Rie Poulsen, MS Public Health, Ph.D. student, Research department of Mental health center 
Copenhagen, Mental Health Services - Capital Region of Denmark
• Email: Rie.poulsen@regionh.dk
Investigator
• Carsten Hjorthøj, MS Public Health, Ph.D., Research department of Mental health center 
Copenhagen, Mental Health Services - Capital Region of Denmark
• E-mail: carsten.hjorthoej@regionh.dk
Supervisor
• Merete Nordentoft, Professor of clinical psychiatry in Copenhagen University, MD, Ph.D., Research 
department of Mental Health Centre Copenhagen, Mental Health Services - Capital Region of 
Denmark
• E-mail: Merete.Nordentoft@regionh.dk
Supervisor
• Birgit Bork Mathiesen, psychologist, Ph.D. Associate professor, Department of Psychology, 
Copenhagen University
• E-mail: Birgit.bork.mathiesen@psy.ku.dk
Supervisor
• Ulla Christensen, Associate professor, Ph.D.,  Department of Public Health, Copenhagen University 
• E-mail: ulch@sund.ku.dk
Supervisor
• Nicole Rosenberg, , Psychologist with specialization in adult psychiatry, Head of Clinic, Mental 
health center Copenhagen, Mental Health Services - Capital Region of Denmark. Adjunct professor, 
University of Aarhus, Denmark
Supervisor
• Ute Bültmann, Professor of Community and Occupational Medicine, MSc in Health Education & 
Health Promotion, Ph.D., University of Groningen
• E-mail: u.bultmann@umcg.nl
Supervisor
• Danish Agency for Labour and Recruitment
• Njalsgade 72 A, 2300 Copenhagen S
Sponsor 

 
12 
 
PROJECT ORGANISATION  
Figure 2: Project organisation - IBBIS 
 
 

 
13 
 
LIST OF ABBREVIATIONS  
Abbr. Meaning
Translation, if applicable
ASRS
Adult Self Rating Scale
BAI
Bech Anxiety Inventory
BDI
Bech Depression Inventory
CBT
Cognitive Behavioural Therapy
Kognitiv adfærdsterapi
CMD
Common Mental Disorders
GP
General practice
Almen praksis
IBBIS
Integreret Behandlings- og 
BeskæftigelsesIndsats til 
Sygedagpengemodtagere
Integrated mental health care and 
vocational rehabilitation for people on sick 
leave
IPS
Individual Placement and Support 
MHC
Mental Health Care
MINI
Mini International Neuropsychiatric 
Interview
MMSE
Mini Mental State Examination
OECD
Organisation for Economic Co-operation and 
Development
PSS
Percieved Stress Scale
RHP
Region Hovedstadens Psykiatri
Mental Health Services - Capital Region
STAR
Styrelsen for Arbejdsmarked og Rekruttering
Danish Agency for Labour and Recruitment 
TAU
Treatment As Usual
Standardbehandling
VR
Vocational Rehabilitation
Beskæftigelsesindsats
  

 
14 
 
1 INTRODUCTION  
1.1 COMMON MENTAL DISORDERS AND SICK LEAVE  
Annually, the total cost of sick leave due to mental health issues attains an estimated level equal to 
3,4 percent of Danish GNP (OECD, 2013). It is reported that 20 % of the Danish population 
between 18-65 years, fulfil the criteria for a mental health disorder according to ICD-10, and three 
quarters of this prevalence is constituted by so called common mental disorders: including 
depression, anxiety, distress, adjustment disorder, and exhaustion disorder (OECD Publishing, 
2012). During the occurrence of these disorders impaired social and occupational functioning are 
seen, e.g. problems with social interaction in occupational contexts, conducting complex cognitive 
tasks and completing tasks with a percieved imminent deadline (D. A. Adler et al., 2006; Wittchen, 
2002).  
OECD (Organisation for Economic Co-operation and Development) estimates that 30 % of the 
unemployed and 45 % of disability pensioners in Denmark fulfil the criteria for an ICD-10 mental 
health disorder, and that the corresponding figures among receivers of cash benefit 2 and sick leave 
benefit are 55 % and 70 %(OECD, 2013). According to the Danish National Health Authorities, 
anxiety and stress conditions was the cause of 11 % of disability pensions from 2010 to 2012 
(OECD, 2013). Common mental disorders causes the largest financial burden because of the high 
prevalence (Harvey, Henderson, Lelliott, & Hotopf, 2009; OECD, 2013) and long-term sick leave, 
and furthermore, unemployment is a risk factor for poor mental health (Wanberg, 2012). 
The severity of symptoms is an established predictor of return to work for depressed people (Dewa, 
Chen, Chau, & Dermer, 2011; S. E. Lagerveld et al., 2010; Nieuwenhuijsen, Verbeek, de Boer, 
Blonk, & van Dijk, 2006). It may be possible to shorten duration of sick leave by providing better 
and more systematic detection and treatment options for people on sick leave because of 
depression and anxiety (J. Christensen & Dürke, 2012). Detection and treatment of depression and 
anxiety in primary care is suboptimal in Denmark according to the Danish Association of 
Psychiatrists and the Danish Health Authority (Danish Health and Medicines Authority, 2007a, 
2007b; Dansk Psykiatrisk Selskab, 2001; Dansk Psykiatrisk Selskab & Dansk Selskab for Almen 
Medicin, 2004). Symptom reduction is, though, by no means the only important factor in the 
process of returning to work (Hees, Koeter, & Schene, 2012) and improved treatment have not 
shown convincing results on improving return to work rates (Nieuwenhuijsen et al., 2014) for 
people with depression. Several studies have investigated the effect of psychological interventions 
on return to work after depression, and the evidence is somewhat mixed. Three studies show 
moderate quality evidence that online or telephone cognitive behavioural therapy  (CBT) show 
greater reductions in sick leave absence than usual care (Bee, Bower, Gilbody, & Lovell, 2010; 
Hollinghurst et al., 2010; McCrone et al., 2003). Nieuwenhuijsen concludes that work-directed 
interventions should be added to treatment interventions to improve vocational recovery for 
depressed people (Nieuwenhuijsen et al., 2014). Work-directed interventions address the barriers 
related to work either by adjusting specific factors that constitute a challenge at work (direct 
support) or by helping the individual cope with the possible barriers to return to work (indirect 
support) (Nieuwenhuijsen et al., 2014).   
Personal and work-related factors probably play an important role in the trajectory of return to work 
(Hees et al., 2012; Nielsen et al., 2012), and the individual’s vocational recovery is most likely 
influenced by other actors then the health care care professionals: The employer, the colleagues, 
social insurance office, and vocational rehabilitation services. In Denmark, the last two are governed 
by the same public office, called job centres. There appears to be an unfortunate lack of coordination 
                                                        
2 Cash benefit: Da.: ”Kontanthjælp” 

 
15 
 
between the health care system and social insurance offices in Scandinavian countries (OECD, 2013). 
This can cause conflicting requirements, and goals and a feeling of confusion, and uncertainty for 
the individual on sick leave at a time where the individual lacks control and certainty (Andersen, 
Nielsen, & Brinkmann, 2012; Mikkelsgård, Granerud, & Høye, 2014). The lack of coordination 
constitutes a missed opportunity to detect cases of depression and anxiety (J. Christensen & Dürke, 
2012), and the OECD suggests that mental health care services and vocational rehabilitation services 
should be coordinated to a larger degree (OECD, 2013).  
Evidence on well-described integrated mental health and vocational rehabilitation interventions is 
scarce. The Individual Placement and Support (IPS) is an intervention with a strong emphasis on 
integration of treatment and vocational support. IPS has shown effect on attaining and maintaining 
work for people with severe mental illness in a Scandinavian context (Bejerholm, Areberg, Hofgren, 
Sandlund, & Rinaldi, 2015; Kinoshita et al., 2013), but there is not yet solid evidence on how IPS 
can best be modified to suit a target group with common mental disorders. Recently a large 
Norwegian study tested integrated employment support designed with an emphasis on IPS 
principles and a work-directed therapy (At work and Coping, AWaC). The study showed promising 
results in terms of faster return to work for people with common mental disorders (Reme, Grasdal, 
Løvvik, Lie, & Øverland, 2015). Whereas IPS is normally provided within the health care system, 
services in the AWaC intervention is provided through the social security system. Intervention 
models that genuinely integrate services from the health care sectors and the employment sector in 
Scandinavia have not yet, to the author's knowledge, been tested on a target group with common 
mental disorders. 
1.2  CURRENT PRACTICES IN MENTAL HEALTH CARE AND 
VOCATIONAL REHABILITATION 
The Danish mental health care system is mainly aimed at treating people with major psychiatric 
disorders. The primary care sector, where the majority of the target group is being treated, is not 
optimally organised and scaled with regard to treating people with common mental disorders 
(Danish Health and Medicines Authority, 2007a, 2007b; Dansk Psykiatrisk Selskab, 2001; Dansk 
Psykiatrisk Selskab & Dansk Selskab for Almen Medicin, 2004; Dansk Selskab for Almen Medicin, 
2010a, 2010b). It has been recommended that people with common mental disorders are offered 
psychotherapy, and general practitioners (GP) can – if they wish and have the skills – offer this to 
all patients whom the GP consider eligible, or refer selected groups to a private practicing 
psychologist, where the patient is partly reimbursed. It is not likely, though, that everybody 
receives the right amount of psychotherapy and neither at the right time (KORA og IMPLEMENT, 
2015).  
 
 

 
16 
 
The reasons for this might be that 
1) GPs – who are responsible for the treatment of most of the relevant patients – are not 
obliged to conduct psychotherapy 
2) Allegedly only half of GPs formally have the competency to conduct psychotherapy (Hauge-
Helgestad, Schlepern Johansen, & Hansen, 2012)  
3) GP reimbursement structure does not support clinical guidelines for psychotherapy in the 
sense that it does not imply any strong incentive (Hauge-Helgestad et al., 2012).  
4) In case of stress conditions and for anxiety patients above 38 years of age, GPs cannot refer 
to partly reimbursed psychotherapy 
5) Even when the patient can be partly reimbursed like aforementioned, the non reimbursed 
expense remaining keep some people from receiving treatment (KORA og IMPLEMENT, 
2015)  
6) By time of referral to private practicing psychologist a significant waiting time may occur, 
thus preventing a timely treatment (KORA og IMPLEMENT, 2015).  
 
In a literature review concerning treatment of anxiety and depression in primary care, one 
Cochrane review was found. The reviews’ conclusion was a recommendation to implement 
collaborative care between primary care and secondary care (mental health services), as a means of 
strengthening treatment (Archer et al., 2012). Hence, ressources have been allocated to a national 
collaborative care intervention under which the Collabri model is currently being implemented in 
the Capital Region of Denmark. However, the Collabri model turned out to be difficult to 
implement, since it requires an agreement between the GP union and the mental health services, 
regarding reimbursing the GPs’ extra expenses. Furthermore, it requires that every GP will 
voluntarily conduct the treatment, and thus take part in the cooperation on the basis of such an 
agreement. Due to the experiences from the Collabri project, it seems necessary to test alternative 
strategies more likely to be implementable in Denmark. Experience like this has already been 
obtained in England, where psychotherapy has been made available to a substantially larger 
proportion of citizens through the project Improving Access to Psychological Therapy (IAPT) 
(Clark et al., 2009). 
Furthermore, in the mental health service, responsibility for vocational rehabilitation has been 
taken only to a minor extent (OECD Publishing, 2012). Despite the fact that holding a job may in 
some cases pose a risk to the mental health of an individual, work is mostly considered to have a 
positive effect on mental health, since it generates income, structure and social interaction, which 
are also important aspects for people with common mental disorders (Bowling, 1995). The 
responsibility for vocational rehabilitation is mainly allocated to the municipalities’ Jobcenter, 
where there has been an increasing focus on psychiatric disorders. There is, however, considerable 
uncertainty in the Jobcenters about how and how fast people can and should be suported in their 
vocational rehabilitation.  
For people who have a reduced work function because of their disability, an optimization of the 
treatment is needed. The evidence for the effect of mental health care on occupational functioning 
is, however, inconsistent (Nieuwenhuijsen et al., 2014). Thus, there is a need to supplement the 
treatment with vocational rehabilitation, in order to support the patient’s early, healthy and stable 
return to work and this should be conducted as an integrated intervention. Accordingly, the OECD 
recommends that mental health care in Denmark should focus on clinical symptoms together with 
occupational aspects, and that models for interventions where vocational rehabilitation and mental 
health care is integrated should be developed and tested (OECD Publishing, 2012). Furthermore, 
the OECD recommends that psychiatric issues among clients in the Danish job centres should be 
identified, and integrated interventions for this group of people implemented (OECD Publishing, 
2012). 

 
17 
 
2 AIMS AND OBJECTIVES 
In this chapter, an overview of the objectives of the six studies in IBBIS is presented. 
2.1 OVERALL AIM OF THE IBBIS PROJECT 
Sick leave due to common mental disorders is increasingly prevalent in Denmark and other high-
income countries and accordingly represent high financial burden to society. Furthermore, 
prolonged duration of sick leave increases the risk of permanent exclusion from the labour market, 
which again is a risk factor for mental disorders. The process of returning to work after sick leave is 
complex, and several actors are important, but there appears to be a lack of coordination between 
relevant services. Therefore, new ways of organizing and coordinating relevant interventions is 
necessary and the IBBIS intervention is a newly developed intervention with the purpose to deliver 
integrated support to people on sick leave because of common mental disorders.  
The IBBIS project will evaluate the integrated intervention and create valuable knowledge about 
the IBBIS population. The overall aim of the intervention is to enhance the process of returning to 
work after sick leave with common mental disorders. A minimum of six studies will describe the 
functioning, and effect of the sub-interventions and provide new knowledge about the trajectory, 
and predictors of the return to work process.   
2.2 OBJECTIVES 
Currently, the IBBIS project consists of six studies. The project contains a large amount of data, 
and it is likely that more studies will be designed. If so, the protocol will be updated accordingly. 
The objectives of the six studies are described below. 
 
2.2.1 THE MENTAL HEALTH ASSESSMENT STUDY 
The objective of this study is: 
 
1.  To examine the effect on vocational status following sick leave of: 
a. Standard GP assessment and standard vocational rehabilitation intervention 
b. IBBIS psychiatric assessment as a supplement to standard GP assessment and 
standard vocational rehabilitation intervention 
 
2. To gain knowledge about the prevalence of psychiatric disease among people on sick leave. 
2.2.2 RCT 1: ANXIETY AND DEPRESSION  
The objective of RCT 1 is to evaluate the effect on return to work of the interventions targeting 
anxiety and depression: 1) standard vocational rehabilitation and standard mental health care 
compared with 2) IBBIS mental health care and standard vocational rehabilitation and 3) mental 
health care integrated with vocational rehabilitation. 
2.2.3 RCT 2: STRESS-RELATED DISORDERS 
The objective of RCT 2 is to evaluate the effect on return to work of the interventions targeting 
stress-related disorders like distress, adjustment disorder and exhaustion disorder: 1) standard 
vocational rehabilitation and standard mental health care compared with 2) IBBIS mental health 
care and standard vocational rehabilitation and 3) mental health care integrated with vocational 
rehabilitation. 

 
18 
 
2.2.4 PROCESS EVALUATION STUDY  
The objective of this study is to evaluate the implementation of specific processes in the IBBIS 
interventions. It aims to provide knowledge about how and under which circumstances the 
integrated IBBIS intervention can be delivered as intended. 
2.2.5 COST-EFFECTIVENESS STUDY  
The objective of this study is to provide an economic cost-effectiveness evaluation of the IBBIS 
intervention. This will enable governing agencies to decide more rationally as to whether IBBIS or 
IBBIS like interventions should be implemented. 
2.2.6 PREDICTORS FOR RETURN TO WORK STUDY 
The objective of this study is to examine which factors predict the duration of time to return to 
work. This will enable all relevant parties – clinicians, case workers and citizens – to tailor return 
to work-interventions more precisely. 
 
 

 
19 
 
3 INTERVENTIONS 
In the following chapter, three overall themes are covered. First, IBBIS - relevant principles and 
research literature regarding mental health and vocational rehabilitation interventions is 
presented. Secondly, a description of the current practice of standard mental health and vocational 
rehabilitation interventions in Denmark are presented. Thirdly, the specific IBBIS mental health 
care and vocational rehabilitation interventions are presented. 
3.1  BACKGROUND 
The IBBIS interventions are based on a broad range of research and principles for mental health 
care and vocational rehabilitation.  
 
The IBBIS mental health care builds on elements from the English Improving Access to 
Psychological Therapy (IAPT) (de Lusignan, Chan, Parry, Dent-Brown, & Kendrick, 2012) where 
talking therapy (mostly cognitive behavioural therapy) is provided to people with common mental 
disorders by IAPT therapists to improve equal access to therapy. IAPT is offered in England as part 
of the primary sector, but only to a small extent in cooperation with general practitioners.  
 
The IBBIS mental health care draws on some principles from collaborative care. According to 
Gunn et al. collaborative care builds on the four principles: 1) A multi-professional approach to 
patient care (collaboration between GP and other health professionals), 2) A structured 
management plan, 3) Scheduled patient follow-ups, and 4) Enhanced inter-professional 
communication (Gunn, Diggens, Hegarty, & Blashki, 2006). A Cochrane review from 2012 
concludes that collaborative care is more effective than usual care in reducing the burden of disease 
from anxiety and depression for people who are treated in primary care (Archer et al., 2012). A 
meta-analysis from 2014 has shown that psychotherapy is a crucial active component of 
collaborative care (Coventry et al., 2014). 
 
A Cochrane review about return to work effects from interventions against depression from 2014 
concluded that psychological treatment provided online or by telephone had a moderate effect on 
return to work, but quality improvements of primary care did not reduce return to work rates. 
Studies about treatment of depression often fail to evaluate the effects on work functioning, sick 
leave, and return to work (Nieuwenhuijsen et al., 2014). Enhanced treatment through collaborative 
care for people with depression has shown to improve functioning (Hudson, Bower, Archer, & 
Coventry, 2016) and the hypothesis in the IBBIS mental health care intervention is that the 
decrease in symptom severity will improve the return to work rate through enhanced functioning.  
 
The literature regarding interventions to improve return to work for people with stress-related 
disorders is not yet conclusive and characterised by inconsistent terminology (van der Klink & van 
Dijk, 2003). Even though distress is, in practice acknowledged as a reason for sick leave from work, 
stress is not considered a diagnosis and only adjustment disorder is mentioned in the ICD-10 
(World Health Organization, 1992).  
 
In a Cochrane review from 2012, regarding interventions aiming at reducing the time to return to 
work in adults with adjustment disorder, Arends et al. found no pharmacological intervention 
beneficial. Neither cognitive behavioural therapy nor problem-solving therapy resulted in symptom 
reduction. However, problem solving therapy had better effects on return to part time work than 
standard treatment. By contrast, neither cognitive behavioural therapy nor problem solving 
therapy resulted in faster return to work full time (Arends et al., 2012). Problem solving therapy 
will be used in the IBBIS vocational rehabilitation intervention, which is described later. Stress 
disorders are often included in the term common mental disorders and interventions that target 

 
20 
 
the return to work process are often designed to aid people with one or more of the common 
mental disorders like depression, anxiety and distress. A meta-analysis has recently shown, that the 
heterogeneous interventions that have a primary or secondary aim to improve return to work has 
very limited effect (Nigatu et al., 2016).   
 
The stress coaching, and additional mindfulness-based stress reduction (MBSR) which are the 
main elements in the IBBIS treatment for exhaustion disorder is inspired by a Danish stress 
management program, developed by Bo Netterstrøm and colleagues. The stress management 
interventions showed improved symptom reduction, and return to work rates for people with 
work-related stress (Netterstrøm, Friebel, & Ladegaard, 2012, 2013). 
 
The IBBIS vocational rehabilitation draws on selected principles from the intervention Individual 
Placement and Support (IPS). IPS is an American intervention with a strong emphasis on 
integration of treatment and vocational support. IPS has shown superiority to standard care in 
attaining and maintaining work for people with severe mental illness internationally (Kinoshita et 
al., 2013) and in a Scandinavian context (Bejerholm et al., 2015), but there is not yet solid evidence 
on how IPS can best be modified to suit a target group with common mental disorders. Recently, a 
large Norwegian study tested integrated supported employment designed with an emphasis on IPS 
principles and a work-directed therapy (At work and Coping, AWaC). The study showed positive 
results regarding faster return to work for people with common mental disorders (Reme et al., 
2015).  
 
Activating problem solving therapy has been used as standard practice by occupational physicians 
in the Netherlands for more than 10 years (van der Klink & van Dijk, 2003). The IBBIS vocational 
rehabilitation has elements from the Dutch activation therapy as developed by Van der Klink and 
colleagues (van der Klink, J. J., Ausems, C. M. M., Beijderwellen, B. D., Blonk, R., Bruinvels, D. J., 
& Dogger, 2007). The participant is inclined to start working through graded activity, and the 
employment consultant monitors the individuals’ progression to make sure stagnation does not 
occur with a clear aim to activate the participant as much as possible (van der Klink, J. J., Ausems, 
C. M. M., Beijderwellen, B. D., Blonk, R., Bruinvels, D. J., & Dogger, 2007). 
 
Recurring sick leave is an important risk in the process of returning rapidly to an existing job 
(Koopmans et al., 2011). Thus, a specific problem-solving method for preventing recurring sick 
leave is provided by the employment consultant. This is the manualized intervention Healthy 
Participation and Relapse Prevention (SHARP) - at work that is initiated by the employment 
consultant once the individual starts working. The problem solving intervention addresses concrete 
problems of return to work and guides the process of problem solving with relevant people like 
colleagues and employers (Arends, van der Klink, van Rhenen, de Boer, & Bültmann, 2014).  
 
Consistency between goals and services in treatment and vocational rehabilitation is essential for 
the individual’s vocational recovery (Andersen et al., 2012; Mikkelsgård et al., 2014). Based on the 
evidence from IPS and the positive effects from integrated interventions like At work and coping 
(Reme et al., 2015) the vocational rehabilitation intervention in IBBIS is integrated with mental 
health care delivery to ensure coherence.  
 
3.1.1 STUDY INTERVENTION   
Three IBBIS interventions are tested in the IBBIS studies. In the two RCT-studies and in the 
Mental Health assessment study, IBBIS interventions are compared to standard interventions. In 
figure 3, an overview of the specific interventions linked to the relevant studies, is provided. For an 
in-depth presentation of the general study design, see chapter 4. 

 
21 
 
 
Figure 3: The interventions linked to the mental health assessment study and the RCT studies 
  
 
 
 
 
 
 
3.2 STANDARD MENTAL HEALTH CARE AND VOCATIONAL 
REHABILITATION 
Standard support for people on sick leave because of common mental disorders is very 
heterogenous in Denmark. There are many providers of public and private services in the health 
care sector, and in the jobcenters that differentiate between the 98 municipalities, and the five 
regions in Denmark.  
 
Primary care is mainly provided by or through the GP, who is a gate keeper for services in the 
regional mental health services. Municipalities are, nonetheless also responsible for health 
promotion, prevention and some types of rehabilitation, which in some municipalities implies 
providing self-management courses for people with common mental disorders.  
 
The vocational rehabilitation is to some degree standardised by legislation. Legislation has a major 
influence on local case management of the sickness benefit case. Legislation and economic 
reimbursement from the state to the job centres to some degree affects the services that are 
provided to support the citizens. Self-management courses are for instance mandatory for people 
on sick leave with common mental disorders and use of unpaid work training results in better 
reimbursement for some groups. The interpretation of legislation, and the time allocated to 
support people on sick leave is nonetheless very different from jobcenter to jobcenter. 
 

 
22 
 
The following description of services that are or should be provided to people on sick leave because 
of depression, anxiety and stress-related disorders is thus a very general description.  
3.2.1 STANDARD MENTAL HEALTH CARE 
The treatment of anxiety, depression, and stress mainly takes place in the primary sector and in the 
private sector. The GP plays an important role. The GP may initiate medical treatment and may 
choose to offer psychotherapy to the citizen. It is estimated that more than 80 % of Danish GPs 
offer supportive conversations. General practitioners are granted a specific charge (No 6101) for 
each supportive conversation session they conduct. The charge is equivalent to approximately three 
regular GP consultations, so the session usually lasts about 30 minutes. This service may be used 
only seven times each year. The practitioner does not receive payment to be supervised (Hauge-
Helgestad et al., 2012). In 2011 275.013 psychotherapeutic session was provided to 127.101 patients 
by GPs (Regeringens Psykiatriudvalg, 2013). 
 
The Danish Association of General Practitioners has published clinical guidelines for the treatment 
of depression and anxiety in general practice (Dansk Selskab for Almen Medicin, 2010a, 2010b). 
However, according to Hauge-Helgestad et al. the reimbursement system for GPs in the treatment 
of anxiety and depression does not support the use of guidelines, because less than 30 % of GPs 
offer cognitive behavioural therapy and seven sessions are now always sufficient (Hauge-Helgestad 
et al., 2012). 
 
The GP can refer some groups of patients to a private practice psychologist, via a certain 
psychologist agreement, where approximately two thirds of the cost is reimbursed. Patients with 
depression (minimum 18 years) and patients with mild to moderate anxiety (between 18 and 38 
years) may be referred through this scheme. Patients with psychological distress cannot be 
referred. There has been a marked increase in the use of this agreement; from 2004 to 2009 its use 
has more than doubled. In 2013, 854 psychologists were a part of the agreement and about 84,300 
patients received a total of 479,100 psychologist sessions. Despite the high number of therapists 
there is on average between eight and ten weeks of waiting time for the start of therapy, and often 
people have to contact several psychologists to find one that takes in new patients. Analyses show 
that referrals via the psychologist agreement often comes from doctors who gives psychotherapy, 
suggesting that some practitioners are less likely to offer therapy, either themselves or referral to 
such (KORA og IMPLEMENT, 2015).  
 
People have the option of paying for psychotherapy in private practice. Because of the high costs of 
psychological therapy in private practice, this is considered a major barrier for utilisation of 
therapy.  
 
Furthermore, there are a number of free services from institutions and organizations that vary 
locally. For instance the Copenhagen Municipality offers mindfulness-based group treatment for 
psychological distress in the municipal prevention centre (Jensen et al., 2015). Some community 
health care centres also offer group-psychoeducation by educators with peer background (KORA og 
IMPLEMENT, 2015). 
 
Additionally, the Mental Health Services of the Capital Region of Denmark offers standardized out-
patient treatment programmes for people with severe anxiety disorder or depression who have not 
benefitted from treatment in primary care. The programmes are offered to people with generalized 
anxiety disorder, social anxiety disorder, single episode depression, recurrent depression and 
adjustment disorders (Danske Regioner, 2014). In 2011 approximately 4.700 adults were treated 
by the regional mental health services for anxiety disorders (Regeringens Psykiatriudvalg, 2013). 
 

 
23 
 
3.2.2 STANDARD VOCATIONAL REHABILITATION 
The 98 jobcenters in Denmark are responsible for vocational rehabilitation and case management 
of the sickness benefit case for people who are on sick leave for minimum eight weeks. Case 
managers thus decide on which benefits the citizen is entitled to receive. Job centres are regulated 
by the Sickness Benefits Act, which has been reformed recently in July 2014 and January 2015 in 
order to shorten the time on sick leave and to improve support for the citizen on sick leave. 
 
A typical course of sick leave is: 
• 
The citizen reports in sick to their employer or the municipality job centre. The employer 
gets reimbursement from the job centre for part of the salary, if the citizen is employed. The 
sickness benefit is paid directly to the citizen if he or she is unemployed.   
• 
If the employer estimates the sick leave to last more than eight weeks, the job centre must 
be informed. The employer must report this within five weeks after the first day of sick 
leave. 
• 
The citizen is required to contact the GP for a specific medical note which describes the 
citizens’ diagnosis (if any) and recommendations for health care. 
Citizens on sick leave can be referred to the job centre within 30 days of sick leave using the so-
called fast track programme, if the citizen or the employer anticipates that the sick leave will extend 
beyond 30 days. 
 
The citizen is supported in returning to the current work place or to attain a new job by vocational 
rehabilitation services provided by the job centre. Support can be offered through group courses or 
individual support and is often outsourced to private companies who offer active employment 
support. Some municipalities also offer specialized programmes or services to other municipalities, 
and the role can also be handled by unemployment funds, educational institutions and unions 
(Bredgaard, Jørgensen, Kongshøj Madsen, & Rasmussen, 2011). Graded activity through part-time, 
unpaid or paid work is a standard method in the job centres. 
 
There are over 20 major private companies that provide heterogeneous services for sickness benefit 
recipients. These organisations work locally and there is great variation in what is being offered in 
their various municipalities and among the various providers. It is very different how the 
interaction between the case manager and these companies is carried out, but written progression 
reports will often be a means of communication.  
3.3 IBBIS INTERVENTIONS 
The aim of the IBBIS interventions is to improve long-term sickness benefit recipients’ process of 
returning to employment after sick leave with common mental disorders. To accommodate this 
complex process, IBBIS aims to improve the process in several domains: improving mental health 
of the individual, facilitating an early vocational rehabilitation process and follow up, and 
improving external factors like integration between different interventions towards the individual. 
 
The IBBIS mental health care and vocational rehabilitation interventions are complex 
interventions (Craig et al., 2008), which are composed by a multiplicity of services, which will help 
the participants in IBBIS in different aspects, all together aiming to improve the process of 
returning to work and create a sustainable work situation for the individual.  
 
The interventions are built on a bio-psycho-social framework (Álvarez, Pagani, & Meucci, 2012). 
The IBBIS interventions are structured to accommodate the assumption, that the struggles people 
experience when being on sick leave with mental problems is a product of biological, psychological 

 
24 
 
and social factors. The bio-psycho-social model implies that these factors, not only coexists but also 
have a great influence on each other. Thus, people need support targeted the psychological and 
biological aspects of the disorder as well as the social environment (including work environment) 
with an emphasis on how these factors interact. To create interventions that can combine these 
elements, the IBBIS interventions are provided by a multi-disciplinary team of professionals from 
the health care sector and the occupational sector.   
 
All interventions are based on the four values: 
 
• 
Individualized evidence-based practice 
• 
Participant self-determination through knowledge  
• 
Person-centered care 
• 
Lowest effective care level 
3.3.1 THE IBBIS TEAM 
An IBBIS team consists of a number of core employees: 
 
• 
Care managers (nurses, occupational therapists, physiotherapists, etc.) with experience 
from mental health care and minimum one-year training in cognitive behavioural therapy 
• 
Employment consultants (case managers from the job centres)  
• 
Team Leader (Can be a care manager or an employment consultant) 
• 
Psychiatrist 
In the IBBIS team, various other employees, like psychologists, psychologists with specialization in 
adult psychiatry3 and junior doctors can do various tasks (e.g. clinical assessments or supervision) 
to ensure that the team is functioning well. In larger teams, it must be ensured that the team has 
the necessary administrative support so that the team leader has the necessary time to support the 
employee's competencies. The citizen's GP will be involved in cooperation with the team, if needed. 
In the sections below, the roles and tasks of the individual professionals and the cooperation with 
the GP are described. 
 
The team will be working together to provide the integrated intervention while sharing location in 
the local community health centre or another location outside the job centre. This organization can 
is seen in figure 4. 
 
 
                                                        
3 In Danish: ”Specialpsykolog” 

 
25 
 
 
 
Figure 4: The IBBIS-team organization 
 
IBBIS participants will receive the mental health assessment before either the integrated IBBIS 
intervention or the IBBIS mental health care alone. The assessment intervention will thus be 
described firstly.  
 
3.3.2 THE MENTAL HEALTH  ASSESSMENT  
All citizens referred to mental health assessment in IBBIS, are either assessed by a care manager, a 
psychologist or a junior doctor. The psychiatrist is always responsible for the assessment results. 
The psychiatrist can delegate the task of conducting the mental health assessment but must always 
ensure that the individual care manager or psychologist has the necessary skills to conduct the 
assessments. 
 
The assessment takes one to two hours and contains the following elements: 
• 
Anamnesis 
• 
Self-assessment through online questionnaire using the Four Dimentional Symptom 
Questionnaire (4DSQ) for depression, anxiety, stress and somatisation (Terluin et al., 
2006b) 
• 
Psychopathological structured assessment using Mini International Neuropsychiatric 
Interview (Sheehan et al., 1998) and the Criteria for Exhaustion Disorder according to the 
National Board of Health and Welfare in Sweden (Besèr et al., 2014) 
• 
Screening for possible attention deficit disorders, personality disorders and dementia with 
the following screening instruments: 
o Standardised Assessment of Personality – Abbreviated Scale (SAPAS) (Moran et al., 
2003) 
o ADHD-symptom checklist for adults (Adult Self Report Scale, ASRS v1.1) (Kessler et 
al., 2005) 
o Mini Mental State Examination (Cole et al., 2006) 

 
26 
 
If possible, a diagnosis will be established. Since organic causation must be ruled out for almost 
any psychiatric diagnoses, the citizens’ GP’s medical certificate for the sick leave case is utilized in 
diagnosing. If the medical certificate determines any psychiatric cause, it will be assumed that 
organic causes are ruled out. 
 
The conclusion from the psychiatric assessment is explained to the citizen orally. Written 
conclusions with diagnoses (if applicable) and description of symptoms are forwarded to the 
citizens’ GP and the job centre.  
3.3.3 MENTAL HEALTH CARE INTERVENTIONS 
Whereas the mental health assessment is conducted similarly for all types of disorders, the mental 
health care is differentiated between the disorders depression, generalised anxiety disorder, social 
phobia, panic disorder, exhaustion disorder, adjustment disorder, and distress. Some features of 
the mental health care are nonetheless common for the seven types of disorders.  
 
The following principles are common for all types of mental health care: 
 
a) Mental health care is delivered by care managers, supervised by psychiatrists 
Treatment in general is supervised by psychiatrists (with regards to monitoring, reassessment and 
adjustment of treatment plan). A medical doctor is always responsible for the mental health care. 
The psychotherapeutic interventions are, if possible, supervised by psychologists.  
 
b) Treatment follows structured treatment guidelines 
The multidisciplinary treatment follows Danish and English guidelines which describe the structure 
of the treatment (duration, frequency, content)(Danish Health and Medicines Authority, 2007a, 
2007b, Dansk Selskab for Almen Medicin, 2010a, 2010b; NICE, 2009). 
 
c) A stepped care principle 
According to the stepped care principle, the severity of the disease determines treatment. A stepped 
care algorithm with 3-5 steps is described for each diagnosis (and combinations of diagnoses). The 
severity of the condition is reassessed monthly by the care manager in collaboration with a 
psychiatrist. If symptoms are not reduced as expected, the participant will be moved to a higher 
treatment step. The stepped care model is recommended for treatment of common mental 
disorders in both Danish and English guidelines (Dansk Selskab for Almen Medicin, 2010a, 2010b; 
NICE, 2009). 
 
d) Collaboration with the GP 
If a psychiatrist in IBBIS suggests that any alterations in the medication of a citizen should take 
place – whether it being initiation, cessation or dose alteration – the GP will be advised to do so, 
and the citizen is advised to contact the GP for help with this. The GP is responsible for conducting 
this treatment. Preferably the psychiatrist and the citizens have achieved agreement on what 
should happen. 
 
A structured close collaboration between the public Mental Health Care Services and the 
individual’s GPs has unfortunately proved to be very difficult in Denmark. The enhanced inter-
professional communication between the IBBIS treatment team and the GP is thus limited to the 
most necessary communication during assessment and with regards to medical treatment in the 
IBBIS intervention. 

 
27 
 
 
3.3.3.1 IBBIS mental health care for depression and anxiety 
The IBBIS mental health care intervention for people with depression and anxiety disorders 
consists of structured treatment guidelines for each of the disorders depression, generalized 
anxiety disorder, panic disorders, social phobia and the combinations of these disorders. 
 
People who have a low level of disease severity are initially provided with psychoeducation. 
Psychoeducation in IBBIS mental health care is provided by a care manager. The individualised 
patient education in IBBIS is developed from the group-based self-management program How to 
manage depression, anxiety, stress, and work. The programme is originally developed by Stanford 
University, The Expert Patient Program Community Interest Company, the National Health 
Service (NHS), and the Danish Committee for Health Education and is a specialised version of The 
Chronic Disease Self-Management Program. The Danish group-based programme proved to be 
effective in reducing symptom level and increasing self-efficacy for people with depression and 
anxiety (S. Christensen & Mehlsen, 2016). 
 
 
The algorithm for initial treatment of people with depression and anxiety disorders are displayed in 
Table 1: Steps of depression treatment and Table 2: Steps of anxiety treatment. 
 
 
Table 1: Steps of depression treatment 
Diagnosis and level 
Initial treatment 
Light depression 
 
- 
Psychoeducation 
Moderate depression 
 
Either: 
- 
Cognitive behavioural therapy (CBT) 
or 
- 
Pharmacological treatment and 
psychoeducation 
Severe depression 
Both: 
- 
Cognitive behavioural therapy (CBT) 
and 
- 
Pharmacological treatment 
Severe depression with 
complication 
Referral to secondary sector 
 
Table 2: Steps of anxiety treatment 
Diagnosis and level 
Initial treatment 
Social phobia 
CBT 
Panic disorder 
CBT 
Generalized anxiety disorder 
- without clear impact on 
functioning 
Psychoeducation 
Generalized anxiety disorder 
- with clear impact on 
functioning 
CBT 
 

 
28 
 
3.3.3.2 IBBIS mental health care for stress-related disorders 
The IBBIS mental health care for people with exhaustion disorder, adjustment disorder and 
distress has three initial treatment steps. The treatment modalities are: bibliotherapy, 
psychoeducation, monitoring, stress coaching and MBSR. Steps are presented in Table 3: Steps of 
treatment of stress-related disorders. 
The citizen’s disorder and level of symptoms are determined during the initial mental health 
assessment. 
 
Table 3: Steps of treatment of stress-related disorders 
Disorder  
Initial treatment 
Light distress (4DSQ stress-scale 10-20) 
for < 2 months 
or  
Moderate distress (4DSQ stress-scale > 
20) for <1 month 
or 
Adjustment disorder < 2 months 
Bibliotherapy 
Patient education programme 
Monitoring by care manager 
Moderate distress (4dsq >20) for > 1 
month 
or 
Moderate distress 
(4DSQ stress-scale 10-20) for > 2 months 
or 
Adjustment disorder for >2 months and 
4DSQ 10-20 
or 
Adjustment disorder for > 1 month and 
4DSQ > 20 
Stress coaching  
Bibliotherapy 
Patient education programme 
Monitoring by care manager 
Exhaustion Disorder according to the 
National Board of Health and Welfare in 
Sweden 
Mindfulness Based Stress Reduction (MBSR) 
Stress coaching  
Bibliotherapy 
Patient education programme   
Monitoring by care manager 
 
 
Stress coaching in the IBBIS mental health care aims to provide stress reduction, create body 
awareness and awareness of stress patterns, and work with appropriate coping mechanisms. The 
stress coaching is conducted individually with the care manager over 7 sessions.  
 
MBSR is a structured 8-week group-based programme, which has been tested in healthy as well as 
physically and mentally ill populations with the aim to reduce symptoms of depression, stress, 
anxiety, and pain, and increase mental health. The MBSR was developed by Jon Kabat-Zinn 
(Kabat-Zinn, 1999) and aims to cultivate mindfulness through formal practices and on integrating 
this capacity into everyday life as a coping resource. A descriptive review from 2011 concluded that 
MBSR is superior to waiting list in improving mental health in self-selected clinical and non- 
clinical populations (Fjorback, Arendt, Ornbøl, Fink, & Walach, 2011). The included studies were 
nonetheless of varying quality and the MBSR programme has to the authors knowledge been tested 
on stressed people on sick leave from work in a few studies. MBSR was, however, an active 

 
29 
 
component in the stress management program by Netterstrøm et al., that improved return to work 
compared to treatment as usual in Denmark (Netterstrøm et al., 2013). 
 
The MBSR groups are facilitated by a certified MBSR teacher, and the care manager is not involved 
in the training. The group meets weekly and are prompted to do 45 minutes of homework (body 
scan, meditation, and yoga). 
 
The patient education in IBBIS mental health care for people with distress, adjustment disorder 
and exhaustion disorder is similar to the patient education for people with depression and anxiety.  
3.3.4 THE VOCATIONAL REHABILITATION INTERVENTION 
The vocational rehabilitation intervention in IBBIS is based on the Danish sickness benefit reform 
from 20154, with emphasis on early intervention and follow-up of the citizens with all types of 
disorders.  The intervention is embedded in regular job centre practice but with more emphasis on 
the specialized support provided by the employment consultant, who in standard services is strictly 
a case manager of the benefit case.  
 
A structured literature review is conducted to assess the current evidence base for vocational 
rehabilitation interventions for people with common mental disorders. 39 studies were included in 
the review with 13 other reviews, 17 RCTs, four cluster-RCTs, and five controlled studies. The 
IBBIS intervention manual is designed with emphasis on problem-solving interventions and a 
combination of therapy and vocational rehabilitation. 
 
IBBIS vocational rehabilitation services are manuallized, and delivered by employment consultants 
who are at the same time case managers for the participants’ sickness benefit case.  
 
The vocational rehabilitation in IBBIS is composed of the following elements, which are delivered 
to meet the participant's individual needs for vocational recovery: 
 
• 
Vocational assessment of the participant's work capacity and barriers in relation to work 
with focus on readiness for return to work (Franche & Krause, 2005), work role functioning 
(Abma, Van Der Klink, & Bültmann, 2013) and return to work self-effficacy (Shaw, Reme, 
Linton, Huang, & Pransky, 2011) 
• 
Process facilitation according to the activation model  
• 
Vocational rehabilitation plan produced in collaboration with the participant and in 
compliance with the vocational rehabilitation manual  
• 
Support in returning to a current workplace and preventing recurrent sick leave. The 
support is focused on rapid, stepwise return to work and is inspired by Dutch guidelines 
and the intervention SHARP-at work (Arends et al., 2014; van der Klink, J. J., Ausems, C. 
M. M., Beijderwellen, B. D., Blonk, R., Bruinvels, D. J., & Dogger, 2007) 
• 
Support in job-search with a focus on the best possible job match inspired by Individual 
Placement and Support (IPS) (T. Burns et al., 2007) 
• 
Case management according to Danish sickness benefit legislation 
• 
Coordination, where relevant, with other public authorities who provide social services 
• 
Involvement of relatives 
 
The vocational rehabilitation intervention is designed specifically for the IBBIS intervention to 
accommodate participants who are on sick leave because of common mental disorders by drawing 
from the following evidence-based vocational interventions: 
                                                        
4 Http://www.ft.dk/ripdf/samling/20131/lovforslag/l194/20131_l194_som_vedtaget.pdf  

 
30 
 
 
• 
Individual Placement and Support (IPS) 
• 
Activating, problem solving therapy 
Besides the principle regarding integration between treatment and vocational support, the key IPS 
principles (T. N. Christensen et al., 2015) featured in the IBBIS intervention are 1) competitive 
work is the goal, 2) attention to participant preferences, 3) rapid job search, 4) systematic job 
development and 5) time unlimited support. This implies that the employment consultants, who 
support individuals in attaining a new job, attempt to minimize the use of temporary, unpaid 
employment, respect participants’ job preferences and support them in their way to achieve this 
type of work, start addressing job search quickly after enrolment in IBBIS, spend time to learn 
about the work conditions and employer needs through continuous communication with 
organizations and employers, and provide support after the individual starts working.  
 
3.3.5 INTEGRATION OF IBBIS INTERVENTIONS 
Consistency between goals in treatment and vocational rehabilitation is crucial [22, 30]. Several 
integrational elements ensure coherence in the participants’ process of returning to work and 
recovering from mental health problems  in the integrated IBBIS intervention:  
 
  
 
• 
A minimum of one roundtable meeting with the participant, the Employment Consultant, 
and the Care Manager where a common plan for return to employment and the support 
from the IBBIS team is decided 
• 
Co-location of all team members 
• 
Multidisciplinary supervision of Care Managers and Employment Consultants together to 
enhance a continous focus on the shared goals of each participant 
The integrated services are based on the theoretical framework relational coordination by Jody 
Gittel in which timely and problem-solving communication between different professionals is 
created by focusing on shared goals, shared knowledge and mutual respect (Gittell, 2006). The 
purpose of the common plan for return to employment is to create focus on the ultimate aim of the 
intervention: a good and fast return to work process. The roundtable meeting creates a forum for 
discussion of the plan and gives the professionals a possiblity to learn about the other 
professionals’ skills and an understanding of the intermediate aims that the other professional set, 
in collaboration with the participant on sick leave.  
3.4 
FIDELITY AND QUALITY ASSESSMENT 
Implementation and provision of the interventions will be monitored through fidelity reviews. 
These will be conducted on the basis of registrations by the IBBIS team members, observations and 
interviews with the professionals and participants, and case reviews. Registrations from IBBIS 
professionals include consultations and services, and participant-specific information like the 
progression of symptoms.  
The fidelity reviews have the purpose of benchmarking specific aspects of implementation, e.g. 
adherence to a specific caseload for each professional, on a fidelity scale designed specifically for 
the IBBIS project. The fidelity review will also benchmark qualitative aspects of implementation 
like adherence to a specific process for conducting team meetings. Because of the standardized 
fidelity scale the quality of implementaion can be compared between teams and the progression in 
score can be monitored.  
 

 
31 
 
Furthermore, a process evaluation will evaluate the implementation of selected core elements of 
the interventions and provide in-depth knowledge about how the following complex elements of 
the interventions are implemented 
 
• 
Collaboration with participants in compliance with the described value shared decision-
making  
• 
Integration of services through relational coordination between IBBIS team members 
 
4 STUDY DESIGN 
In the following chapter, the study design of the six studies in the IBBIS-project is presented. 
Several parts form the IBBIS project, and the design of each part of the project is described in this 
chapter. First, the study design of the Mental Health Assessment study is presented, followed by 
the two RCT-studies. Since citizens are screened for eligibility to the RCT-studies in the mental 
health assessment, these studies are linked.  
 
The overall project flow is depicted in the section Trial flow chart. Citizens eligible for the mental 
health assessment study are referred and psychiatrically assessed as a part of this study, and they 
consent to referral and participation in the same procedure. By participating in the mental health 
assessment, subjects are assessed for eligibility for one of the two RCT studies as well. If eligible, 
subjects are prompted for consent to the relevant RCT as the last part of the assessment. 
 
The other studies, The Process evaluation study, The Cost-effectiveness study, and the Predictors 
for return to work study are subsequently described in each chapter section. 
4.1 THE MENTAL HEALTH ASSESSMENT STUDY 
4.1.1 INTRODUCTION 
4.1.1.1 Issues with diagnosing common mental disorders 
According to ICD-10, there is “long-standing and notoriously difficult problems associated with the 
description and classification” of mood [affective] disorders (F30-F39). ICD-10, however, provides 
a detailed description and diagnostic guidelines, seeking to increase reliability across countries and 
clinical settings (World Health Organisation, 1993).  
 
Still, ICD-10 describes the need for categories like various subdivisions of adjustment disorder 
(F43.2) with the purpose “to facilitate the description of disorders manifest by a mixture of 
symptoms for which a simpler and more traditional psychiatric label is not appropriate but which 
nevertheless represent significantly common, severe states of distress and interference with 
functioning”, like the disorders corresponding to inclusion criteria of IBBIS RCT2: distress, 
adjustment disorder and exhaustion disorder (World Health Organisation, 1993). ICD-10 notices 
also that “difficulties in using these categories reliably may be encountered, but it is important to 
test them and - if necessary - improve their definition”. Though written in 1993, there is, to the 
authors’ knowledge, not since developed any significant consensus on how to distinguish these 
disorders, due to lack of a widely accepted definition of distress (van der Klink & van Dijk, 2003). 
 

 
32 
 
4.1.1.2 Consequences of diagnoses 
Uncomplicated and not severe mood and anxiety disorders are as most adjustment disorders 
considered common mental disorders, and they are differential diagnoses to each other. Although 
there are many common features among common mental disorders, there are different treatment 
recommendations, especially regarding treatments that have effect on RTW time. For adjustment 
disorder, problem solving therapy have shown moderate effect, whereas CBT did not (Arends et al., 
2012). Hence, assessment before treatment is crucial. The purpose of the mental health assessment 
is thus both to provide correct treatment of a specific subcategory (e.g. social anxiety) of common 
mental disorders, but also to provide correct treatment for people, who suffers from other 
disorders (e.g. OCD or PTSD), that are not included in the RCT-studies. 
 
4.1.2 AIMS AND OBJECTIVES 
The objectives of this study are  
1) to examine the effect on vocational status following sick leave after 
a. Standard GP assessment and standard vocational rehabilitation intervention 
b. IBBIS mental health assessment as a supplement to standard GP assessment and 
standard vocational rehabilitation intervention and 
2) to gain knowledge about the prevalence of psychiatric disorders among people on sick leave. 
4.1.3 PARTICIPANTS 
4.1.3.1 Inclusion criteria 
• 
Sickness benefit receipient on sick leave for no less than four weeks, and at sick leave at first 
follow-up appointment in municipal job centre. 
• 
on sick leave from job or vacancy, due to a psychiatric disorder diagnosed by the GP, or 
suspected as reason for sick leave, by either the sick leave absentee, or the municipal case 
worker 
• 
attached to a job centre in one of the following municipalities: 
o Copenhagen 
o Gladsaxe 
o Gentofte 
o Lyngby-Tårbæk 
• 
aged 18 or more 
• 
gives consent 
 
4.1.3.2 Exclusion criteria 
• 
Marked with a security note (SOS) in the jobcenter  
4.1.4 ASSESSMENT PROCEDURE 
4.1.4.1 Visitation 
When citizens are referred to the IBBIS project from one of the four referring municipalities, all 
referrals are controlled by a psychiatrist, to see if inclusion criteria are met. This can be done by 
reviewing referral file material, or, if necessary, by a clarifying telephone interview with the citizen. 
 
If the mental health assessment is relevant and the citizen decides to participate, the job centre 
case manager will collect written informed consent that the citizen understands the implications of 

 
33 
 
participating in the mental health assessment and forward information about the citizen to the 
IBBIS team. This first consent implicates that the IBBIS team can share data with: 
• 
GP 
• 
Job centre 
• 
Research team 
The citizen is informed that she or he can bring a relative to an additional information meeting, 
where an IBBIS team member will inform about the assessment and the implications for the citizen 
and that she or he has the opportunity for a 24-hour reflection period before the decision to 
participate has to be made. Furthermore, citizens are informed that the assessment requires 
completion of an online questionnaire (approximately 1 hour) and a face-to-face interview with a 
health care professional from the IBBIS team (approximately 2 hours).  
4.1.4.2 The mental health assessment 
When it is obvious, at reception of referral material that a psychiatric diagnosis is already well 
established, and that current treatment is sufficient (e.g. referral to hospital based mental health 
care is already planned), the citizen is referred back to the jobcentre with this assessment 
information. 
 
If not, the standard procedure is as follows: The baseline interview and mental health assessment 
will take place (at the earliest 4 weeks after the first day of the sick leave). This interview is 
manualised and conducted as follows: 
 
1. The psychiatrist allocates the citizen to an assessor, either a psychiatrist, a MD, a 
psychologist or a care manager trained in assessment. 
2. An assessor assess the citizen through interview including the following elements: 
a. Anamnesis: Report about course of sick leave and symptoms 
b. Mini International Neuropsychiatric Interview (Sheehan et al., 1998), modified for 
IBBIS, and 
c. Standardised Assessment of Personality – Abbreviated Scale (Moran et al., 2003), 
and 
d. ADHD symptom checklist: Adult Self Report Scale, ASRS v1.1 (L. Adler, Kessler, & 
Spencer, 2003) 
e. If dementia is suspected: Mini Mental State Examination (A. Burns, Brayne, & 
Folstein, 1998) 
3. The citizen completes Four-Dimensional Symptom Questionnaire (4DSQ)(Terluin et al., 
2006b) 
4. Organic causation is ruled out by the GP, when the GP in their medical note establishes a 
psychiatric cause of the symptoms 
The main responsibility for the assessment lies with the psychiatrist. Assessment interview can be 
delegated to others, under supervision of a psychiatrist. 
 
If it is assessed that the citizen has anxiety, depression or a stress-related disorder (F40-F41, F32-
33, or F43 in ICD10), the citizens will be offered treatment in the IBBIS RCTs, if the citizen is 
otherwise eligible in all regards. If the citizen consents participate in an IBBIS RCT, the citizen is 
randomized. 
If the citizen consents to an RCT, and is randomized to control group, or if the citizen does not 
consent, the job centre and the GP is informed hereabout, regarding the assessment result 
(diagnosis included, if applicable), and receives recommendation of treatment of the citizen. 

 
34 
 
If the citizen consents to an RCT and is randomized to one of the intervention groups in IBBIS 
(group 2 or 3), the job centre and GP is informed about this as well as about assessment result 
(diagnosis included). For an in-depth presentation of the RCT-groups/design see section 4.2 
4.1.5 DATA ANALYSIS 
4.1.5.1 Study groups 
An intervention cohort will be formed: all citizens who are assessed in the IBBIS team but who 
does not receive IBBIS treatment, due to either being in the control group, or not giving consent to 
participate in an RCT. A control cohort will be formed, consisting of citizens eligible for referral to 
IBBIS assessment but who are not offered the assessment due to limitations in referral capacity. 
These groups will be coupled to an integrated database for labour market research5, which contains 
data regarding demography (e.g., gender, age, marital status, address, place of birth and national 
citizenship), family information, income, work status and more. 
4.1.6 OUTCOMES 
Primary outcome in the IBBIS project lies in the RCT studies, see section 4.2. Hence, in the mental 
health assessment study, all outcomes are classified as other or explorative, as follows: 
4.1.6.1 Other outcomes 
1. Difference between cohorts will be calculated regarding time from baseline to partial return 
to work, part time RTW at 6, 12 and 24 months, calculated as a hazard ratio, using cox 
regression. Likewise, the difference between cohorts will be calculated regarding time from 
baseline to full RTW at 6, 12 and 24 months. 
2. Which diagnoses describes the cohort? (ICD10 diagnoses) 
3. Which sociodemographic factors describes the cohort? (age, gender, previous labour 
market attachment) 
4.1.6.2 Exploratory outcomes 
Furthermore, a descriptive analysis of the assessed citizens (the index cohort) will be performed, of 
the group who received the IBBIS assessment, regarding: 
1. Which treatment has the cohort been offered previous to IBBIS assessment and which 
sociodemographic or personal factors predicts this? (T-test for difference in proportions, 
and RR ratios) 
2. Does the assessor influence the choice of diagnoses? (T-test of assessor differences in 
proportions of inclusions into RCT1 vs. RCT2) 
4.1.7 POWER CALCULATIONS 
4.1.7.1 Sample size and cohort size number ratio 
The size of the intervention cohort is determined by the needs of the RCTs, since referral to the 
assessment study will only persist as long as at least one RCT needs enrolment. We plan to include 
400 participants from the RCT control groups and approximately 400 participants who receive 
assessment but who are not included in an RCT for any reason; and hence 800 subjects will be 
included in the assessment study intervention cohort. 
The number of subjects in the control cohort will also be determined by limiting factors external to 
the project and is hence not controllable. Control cohort including rates is by the relevant 
collaborators esteemed to such that it is not unlikely that the number will reach a similar 800, and 
hence, the ratio between numbers in the two cohorts is 1:1. 
 
                                                        
5 Da.: Integreret Database for Arbejdsmarkedsforskning (IDA) 

 
35 
 
4.1.7.2 Power calculation - Expected time to events 
The time to the event return to work is in the RCT sample size calculations conservatively assumed 
to be 210 days, (see 4.2.6.1 Sample size calculation), and we want to be able to detect a difference in 
mean time to events of 14 days, which requires a sample size of 6199 subjects in each group. Time 
to partial return to work is easier to detect, since it – in its nature – occurs earlier, and is also an 
important event in the process of stable return to work. Expected duration of time to partial return 
to work, is set to 100 days in the control group, on the basis of results from a Cochrane review of 
RTW intervention in common mental disorders (Arends et al., 2012), and regarding this outcome 
we still seek to detect a difference of 14 days, and hence the time to event of the intervention group 
is set to 86 days. 
4.1.7.3 Power calculations for the mental health assessment study 
 
Table 4: Power calculations for the mental health assessment study 
Outcome 
Power 
Comments 
Time to partial RTW at 6, 12 and 
24 months 
6 months: 0,74 
 
12 months: 0,83  
 
24 months: 0,855 
At 12 months: To reach a 
power of 0,9 we need 989 
subjects in each group, which 
do not seem unlikely 
Time from baseline to return to 
work (RTW) at 6, 12 and 24 
months 
6 months: 0,156 
 
12 months: 0,214 
 
24 months: 0,276 
 
 
4.1.8 STATISTICAL ANALYSES  
Controls will be matched individually with cases (the ones who receives IBBIS assessment), 
utilizing propensity score matching, which is a method useful to eliminate baseline differences 
between groups. Match variables are the following: gender, age, previous health care consumption, 
municipality, previous work status and social benefits. Analyses will be conducted using 
conditioned logistic regression and cox-regression. 
4.2  RANDOMIZED CONTROLLED TRIALS 
The effect on return to work from 1) the integrated IBBIS mental health care and IBBIS vocational 
rehabilitation and 2) the IBBIS mental health care intervention alone will be investigated in two 
randomized controlled trials by comparison with standard mental health care and standard 
vocational rehabilitation. The RCT studies are designed as three-armed investigator-initiated 
multi-centre parallel superiority trials: RCT 1 for people with generalized anxiety disorder, panic 
disorder, social phobia or depression, and RCT 2 for people with stress-related disorders. 
 
The design of the two randomised controlled studies are described in peer reviewed articles in 
2017, see (Poulsen, Fisker, Hoff, Hjorthøj, & Eplov, 2017a, 2017c). 
 
RCT 1: The objective of this study is to compare the effects of three different interventions on 
participants with anxiety and depression.  

 
36 
 
 
RCT 2: The objective of this study is to compare the effects of three different interventions on 
participants with stress disorders, specified as exhaustion disorder, adjustment disorder or 
distress.  
 
In each RCT, each participant is randomized into one of these three groups (in the ratio 1:1:1): 
• 
Group 1: Control group, treatment as usual (standard MHC and standard VR) 
• 
Group 2: IBBIS mental health care (and standard VR) 
• 
Group 3: Integrated IBBIS mental health care treatment and vocational 
rehabilitation 
Figure 5: The three groups in RCT1 & RCT2 
 
Figure 5 shows the three arms of each RCT study and the allocated interventions on two 
parameters: mental health care and VR. The trials are randomized and blinded multicentre studies. 
 
The following hypotheses accounts for both RCT1 and RCT2: 
 
A. 
 
 
 
 
 
H0: There is no significant difference in RTW-time at 12 months between participants in group 
3 and group 2.  
 
H1: There is significant difference in RTW-time at 12 months between participants in group 3 
and group 2.  

 
37 
 
 
B 
 
C 
 
 
 
 
 
C 
 
 
 
 
 
 
 
4.2.1 PARTICIPANTS 
Participants are referred to the IBBIS project from one of the four referring municipalities. 
Screening for eligibility for participating in the RCT-studies is performed during the mental health 
assessment.  
 
4.2.1.1 Inclusion criteria 
The following inclusion criteria apply to both RCT- studies: 
• 
Receiver of sickness benefit for minimum four weeks at baseline: either on sick leave from 
work or unemployment at baseline 
• 
Resident of one of following municipalities: Copenhagen City, Gladsaxe Municipality, 
Municipality of Lyngby-Taarbæk, or Gentofte Municipality 
• 
Able to speak and understand Danish and capability of  completing written and oral 
interviews without the use of an interpreter   
• 
18 years or older 
• 
Have given written consent to participate   
 
To be eligible for RCT 1 the participant has to meet the criteria for at least one of the following 
criteria: 
• 
Generalized anxiety disorder (GAD, F41.1), social phobia (F40.1) or panic disorder (F41.0), 
according to ICD-10 evaluated through mental health assessment 
• 
Depression (single episode or recurring unipolar) according to ICD-10 evaluated through 
mental health assessment (F32-F33) 
 
To be eligible for RCT 2 the participant has to meet the criteria for at least one of the following 
criteria: 
• 
Exhaustion disorder according to The Swedish National Board of Health and Welfare 
(NBHW) criteria for exhaustion disorder assessed through the mental health assessment 
(The Swedish National Board of Health and Welfare, 2003) 
• 
Adjustment disorder according to ICD-10 (World Health Organization, 1992) evaluated 
through mental health assessment 
H0: There is no significant difference in RTW-time at 12 months between participants in group 
3 and group 1.  
 
H1: There is significant difference in RTW-time at 12 months between participants in group 3 
and group 1.  
 
H0: There is no significant difference in RTW-time at 12 months between participants in group 
2 and group 1.  
 
H1: There is significant difference in RTW-time at 12 months between participants in group 2 
and group 1.  

 
38 
 
• 
Distress according to 4DSQ (Terluin et al., 2006b) and evaluated through mental health 
assessment 
4.2.1.2 Exclusion criteria 
The citizen cannot participate in either intervention studies if he or she: 
• 
Is pregnant  
• 
Has a high degree of suicidal ideation evaluated through mental health assessment, aided 
by the MINI interview (Sheehan et al., 1998) 
• 
Has dementia evaluated by the MMSE screening instrument (Cole et al., 2006) 
• 
Abuse of alcohol or other drugs to the degree that the participant cannot profit from therapy  
(evaluated at the mental health assessment) 
• 
Is judged to need psychiatric secondary sector care 
• 
Unstable somatic condition that hinders participation in the project   
• 
Participation in the research project Collabri 
• 
Does not accept to abstain from taking part of any psychotherapy or psychotherapy-like 
treatment, outside the IBBIS project, during treatment in an IBBIS intervention group, if 
the participant is randomized to receive the intervention 
• 
Marked with a security note (SOS) in the job centre  
 
 
4.2.2 OUTCOMES AND DATA COLLECTION 
The effects of the interventions in the RCT-studies are measured on primary, secondary and 
exploratory outcomes. Measurements are done at baseline and after 6, 12 and 24 months. Baseline 
questionnaires are completed between the time of referral from job centre and baseline assessment 
interview. 6-, 12- and 24-month follow-up is a combination of self-rated questionnaires and 
register data. The project's primary outcome is based on register data, and there will not be 
obtained interviewer-based follow-up information. Secondary outcomes are measured by both 
register data and questionnaire data. 
 
Data for the RCT studies is collected through four types of sources: 
• 
Case report forms (CRF) from the mental health assessment  
• 
Registration sheets completed by professionals 
• 
Patient reported outcomes answered on-line 
• 
Register data  
 
 
 

 
39 
 
An overview of how the different types of data collection takes place during the study can be seen in  
Table 5: Power calculations for the mental health assessment study. 
 
Table 5: Power calculations for the mental health assessment study 
 
Prior to 
baseline 
t-0 
Baseline t0 
6 month- 
follow-up, 
t1 
12-month 
follow-up, t2 
24-month 
follow-up, t3 
CRF from 
personal 
interview 
 
X 
 
 
 
Registration 
sheets 
 
X 
Continuous registration 
Self-
assessment 
data 
X 
 
X 
X 
X 
Register data 
 
X 
X 
X 
X 
 
 
4.2.2.1 Primary outcome 
The primary outcome of the trial is the time from baseline until stable return to work. Baseline is 
defined as the day the participants are randomized. Stable return to work is defined as a coherent 
period of 4 weeks without receiving sickness benefits. This is similar to studies examining return to 
work after sick leave among people with common mental disorders (Bakker et al., 2007; Brouwers, 
Tiemens, Terluin, & Verhaak, 2006; Suzanne E. Lagerveld, Blonk, Brenninkmeijer, Wijngaards-de 
Meij, & Schaufeli, 2012; Noordik et al., 2013; Rebergen, Bruinvels, Bezemer, van der Beek, & van 
Mechelen, 2009). 
 
It is tested, if participants, receiving a mental health care intervention (group 2), and participants 
receiving both an integrated health care treatment and vocational intervention (group 3) has a 
faster return to work than people receiving treatment as usual (group 1). This is determined at 12 
months follow-up. This is shown in  
Table 6: Primary outcome. 
 
The primary outcome is based on data from the DREAM database. The DREAM database is a 
Danish longitudinal database based on data from the Ministry of Employment, the Ministry of 
Social Welfare and Education and the Ministry of Refugee, Immigration and Integration Affairs. In 
addition, it covers data from The Population Register (CPR) and SKAT (Danish Tax Agency). The 
register includes all persons who have received certain social benefits from mid-1991 onwards. 
DREAM covers approximately 5 million people. 
 
All participants receive sickness benefits at baseline. Participants in the trial are citizens who, prior 
to receiving sickness benefits, have been: 

 
40 
 
 
1. Salaried employees 
2. Self-employed 
3. Receiving unemployment benefits 
4. In flexible jobs (Da.: “flexjob”) 
 
The criterion for ‘stable return to work’ differs between these groups. In group 1 and 2 "stable 
return to work" is defined as obtaining employment for minimum four weeks. This event is 
detected through DREAM data when no benefit code (Da. “ydelseskode”) is specified in the 
DREAM register, but an industry code (Da. “branchekode”) is set, indicating that the participant 
has paid labour.  
 
Participants in group 3 with flexible jobs before sick leave are registered in the DREAM register 
with service code "774 = Flex job”, flexible job with sickness benefits. If this code is set at least one 
week before the transition to sickness benefits, "stable return to work" is defined as either 4 
consecutive weeks with service code "771 = Flex job" or 4 weeks with an industry code as a proxy 
for income (ordinary work)  
 
Table 6: Primary outcome 
 
 
 
 
 
 
 
 
 
4.2.2.2 Secondary outcomes 
There are seven secondary outcomes and data are collected through the DREAM database and self-
rated questionnaires. The secondary outcomes are shown in Secondary outcomes. 
 
Table 7: Secondary outcomes  
Data 
source 
Outcome 
Baseline 
6 
months  
12 
months 
24 months 
DREAM 
data 
Amount in ordinary work 
 
 
X 
 
DREAM 
data 
Time from baseline to return to 
work (RTW) 
 
X 
 
X 
DREAM 
data 
Time from first day of RTW until 
possible recurrent sick leave 
 
 
 
X 
Q
ue
sti
on
Depressive symptoms measured 
by Beck Depression Inventory 
X 
X 
 
 
 
Table 6: Primary outcome 
 
 
Data 
source 
Outcome 
Baseline 6 
months  
12 
months 
24 
months 
Primary 
 
DREAM 
database 
Time from baseline 
to return to work 
(RTW)  
 
 
X 
 
 

 
41 
 
(BDI) (Aaron T Beck, Brown, 
Epstein, & Steer, 1988) 
Anxiety  symptoms measured by 
Beck Anxiety Inventory (BAI) 
(Aaron T. Beck, Steer, & Carbin, 
1988) 
X 
X 
 
 
Stress-symptoms measured by 
Cohen perceived stress scale (PSS) 
(Cohen, Kamarck, & Mermelstein, 
1983) 
X 
X 
 
 
Social and work related function 
measured by WSAS (Mundt, 
Marks, Shear, & Greist, 2002) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
42 
 
 
4.2.2.3 Exploratory outcomes 
 
Exploratory outcomes are described in Table 8: Exploratory outcomes and follow-up time: 
 
Table 8: Exploratory outcomes and follow-up time 
Data 
source 
Outcome 
 
Follow-up 
Baseline 
6-month 
12-month 
24-
month 
DREAM 
data 
Weeks of work from baseline to current 
follow up 
 
 
 
X 
X 
Questionnaires 
Symptoms of Distress, anxiety, depression 
and somatization by Four-Dimensional 
Symptom Questionnaire (4DSQ) (Terluin et 
al., 2006a) 
X 
X 
X 
X 
Depressive symptoms measured by Beck 
Depression Inventory (BDI)(Aaron T. Beck et 
al., 1988) 
X 
 
X 
X 
Anxiety  symptoms measured by Beck 
Anxiety Inventory (BAI) (Aaron T. Beck et al., 
1988) 
X 
 
X 
X 
Stress-symptoms measured by Cohen 
perceived stress scale (PSS) (Cohen et al., 
1983) 
X 
 
 
X 
 
X 
Social and work related function measured by 
WSAS (Mundt et al., 2002) 
X 
 
X 
X 
Burn-out symptoms by Karolinska 
Exhaustion Scale (KES) (Saboonchi, Perski, & 
Grossi, 2013)  
X 
X 
X 
X 
Health-related quality of life by EQ-5D-5L 
(Brazier, Roberts, Tsuchiya, & Busschbach, 
2004) 
X 
X 
X 
X 
General Quality of life scale ved Flanagans 
QOLS (Burckhardt & Anderson, 2003) 
X 
X 
X 
X 
Self-efficacy concerning symptoms - IPQ 
subscale on personal control (Moss-Morris et 
al., 2002) 
X 
X 
X 
X 
Return to work self-efficacy by  RTW-SE 
(Suzanne E. Lagerveld, Blonk, 
Brenninkmeijer, & Schaufeli, 2010) 
X 
X 
X 
X 
General self-efficacy by General Self-efficacy 
scale (GSS (Schwarzer & Jerusalem, 1995) 
X 
X 
X 
X 
Interview ICD 10 diagnosis, guided by Mini 
International Neuropsychiatric Interview 
(MINI) (1998) 
X 
 
 
 
 
 
 

 
43 
 
 
 
 
 
4.2.2.4 Other outcomes 
Other outcomes are shown inTable 9: Other outcomes. 
 
Table 9: Other outcomes 
 
 
 
 
 
 
 
 
Baseline 
Follow-up 
Data source 
Outcome 
 
6-month 
12-
month 
24-
month 
Interview 
Screening for 
personality disorder 
by SAPAS (Moran et 
al., 2003) 
X 
 
 
 
Questionnaire 
Client satisfaction 
with treatment  
measure: CSQ-8 
(Attkisson & Zwick, 
1982) 
 
X 
 
 
Questionnaire 
Presenteeism by 
Stanford 
Presenteeism Scale 
(SPS) (Koopman et 
al., 2002) 
 
 
X 
X 
Interview 
Screening of ADHD 
symptoms by ASRS 
X 
 
 
 
 
 
4.2.2.5 The questionnaires 
 
A short description of the questionnaires used for all outcomes are presented below.  
 
The Beck Depression Inventory (BDI–II) consists of 21 items to assess the intensity of depression 
in clinical and normal patients. Each item is a list of four statements (0 to 3) arranged in increasing 
severity about a particular symptom of depression (A.T. Beck, Steer, & Brown, 1996). The Beck 
Anxiety Inventory (BAI) is a 21-item general questionnaire for anxiety, measuring symptoms 
during the last week rated on a four-point Likert-scale from 0 to 3 (Osman et al., 2002). The BDI 
and BAI has shown excellent psychometric properties, with internal consistency: α = 0.92 and α = 
0.93 respectively (Osman et al., 2002; Osman, Kopper, Barrios, Gutierrez, & Bagge, 2004). Cohens 
Perceived Stress Scale (PSS) is a global measure of perceived stress. The scale was originally a 14 
item questionnaire, and it has later been moderated to a 10-item questionnaire which shows 
improved and satisfactory psychometric properties (Lee, 2012). The Work and Social Adjustment 
Scale (WSAS) is a simple, reliable, five-item scale which measures functional impairment related to 
an identified problem (Mundt et al., 2002), which is defined in this trial as ‘psychological 
symptoms’. 
 
The Four-Dimensional Symptom Questionnaire (4DSQ) is a 50-item questionnaire designed to 
assess common psychological symptoms in the last week and has a special focus on distinguishing 

 
44 
 
general distress from depression, anxiety, and somatization (Terluin et al., 2006a). The Karolinska 
Exhaustion Scale (KES) 26-item version measures the degree of exhaustion disorder and the four 
inter-related dimensions of exhaustion disorder according to the Swedish National Board of Health 
and Welfare: lack of recovery, cognitive exhaustion, somatic symptoms, and emotional distress 
(Saboonchi et al., 2013; The Swedish National Board of Health and Welfare, 2003). The EQ-5D-5L 
is a measure of health status in five domains: mobility, self-care, usual activities, pain/discomfort 
and anxiety/depression and also includes a Visual Analogue Scale from 0 (worst imaginable health 
status) to 100 (best imaginable health status) (Turner, Campbell, Peters, Wiles, & Hollinghurst, 
2013). Flanagan’s QOLS is a 16-item instrument that measures five conceptual domains of quality 
of life: material and physical well-being, relationships with other people, social, community and 
civic activities, personal development and fulfilment, recreation, and independence (Burckhardt & 
Anderson, 2003). The six-item Personal Control subscale from the revised version of the Illness 
Perception Questionnaire (IPQ-R) is used to evaluate the participant’s self-efficacy regarding 
symptom management (Moss-Morris et al., 2002). Return to work self-efficacy (RTW-SE) is an 11-
item measure for self-efficacy believes regarding return to work where respondents are asked to 
respond to statements about their jobs, imagining that they would start working tomorrow in their 
present emotional state (Suzanne E. Lagerveld et al., 2010) . The General Self-Efficacy Scale is a 10-
item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of 
difficult demands in life (Schwarzer & Jerusalem, 1995). Client Satisfaction Questionnaire (CSQ-8) 
is an eight-item questionnaire which is used to measure the participants’ satisfaction with mental 
health care services and vocational rehabilitation (Attkisson & Zwick, 1982). Presenteeism refers to 
the state where a person attends work while being sick (Johns, 2010) and is used as a proxy 
measure for returning to work while having reduced workability.  
 
A high response rate for the questionnaire data is secured by assertive prompting of the 
participant. Each participant will receive up to six personal contacts through telephone, text, 
formalized e-mail (e-boks meddelelse in Danish) if this is necessary to secure timely answers and if 
it is approved by the participant through written consent.  
 
4.2.3 RANDOMIZATION 
Centralized randomization will take place according to a web-based, computer-generated allocation 
sequence with varying block sizes kept unknown to the assessors. Randomization takes place in a 
ratio of 1:1:1. The Odense Patient Data Explorative Network (OPEN)6 is responsible for the 
randomization; administrative personnel in the IBBIS team perform the online randomization; and 
the IBBIS team leader will assign the participant to interventions and professionals. 
 
We expect that service delivery can vary from municipality to municipality and that the process of 
gaining a new job from unemployment will take a longer time than returning to an existing job. 
Previous research has shown that diagnosis is a possible predictor of return to work (Nielsen et al., 
2011) . Thus, the randomization is stratified according to  
 
i. 
Labor Market status (vacant vs. in job) 
ii. 
Municipality affiliation 
iii. 
Diagnosis: 
o in RCT 1: Anxiety respectively depression 
                                                        
6 
http://www.sdu.dk/en/om_sdu/institutter_centre/klinisk_institut/forskning/forskningsenheder/open/ope
ns_faciliteter/randomize 

 
45 
 
o in RCT 2: Stress –related disorders, respectively exhaustion disorder, adjustment 
disorder and distress  
 
 
4.2.4 BLINDING 
Participants in the trial cannot be blinded to the group allocation. The IBBIS team Care Managers 
and Employment Consultants are also not blinded to the interventions received by the participants. 
Referrers and researchers will be blinded to the allocation sequence and block size. The researchers 
will be blinded to intervention group allocation during data analyses of the primary outcome, as 
well as secondary, and exploratory outcomes at 6 and 12 months. Blinding will be sustained during 
the analysis phase and while drawing the conclusion. 
 
Since results of 6- and 12-month follow-up will be presented before analysis of data from 24 
months follow-up, it is not possible to maintain blinding of researchers during the analyses of data 
from 24 month follow-up. This is certainly a risk of bias, but since the primary outcome at 24 
months are based on register data and self-assessment, results are not likely to be affected.  
 
4.2.5 DATA MANAGEMENT 
All data management in IBBIS is carefully described in an application approved by the Danish Data 
Protection Agency in 2016. This application describes in detail where and how the data are 
managed, stored and secured. Furthermore, it lists all staff members dealing with data, and where 
and how these staff members are affiliated, respectively. The application is structured and honours 
a detailed and comprehensive list of demands, ensuring compliance with all relevant data 
management legislation. 
 
In general, all data management in the IBBIS project complies with the principles that 
1) All electronic data are stored at secured servers at closed networks, 
2) All data transfer between staff members and other approved data managers or managing 
institutions, are carried out using only tunnel encrypted e-mailing and  
3) All physical data material is stored in locked spaces, in locked facilities. 
 
4.2.5.1 Data quality 
Assessors have all received proper training in the included instruments/scales. The psychiatrist will 
observe the case managers’ assessments regularly in order to secure the quality of the assessments. 
All assessment and baseline diagnoses at t0 will be approved by an experienced psychiatrist. 
 
There will be continuous quality assurance of the professionals’ registration sheets by the 
secretariat to ensure that all consultation details with care managers and employment consultants 
(adherence to services), change in treatment steps, initial diagnoses, and reasons for withdrawal 
are registered. All errors regarding randomization, registration or assessment will be recorded in a 
logbook.  
No formal audit has been planned.  

 
46 
 
4.2.5.2 Data monitoring committee and interim analysis 
Since the IBBIS trial is not assumed to be associated with any risk of harm, according to 
investigations of similar interventions, a data monitoring committee will not be appointed, nor will 
any interim analysis be performed.     
 

 
47 
 
4.2.6 STATISTICAL METHODS  
4.2.6.1 Sample size calculation 
The sample size is based on a sample size calculation, using the ‘Power and Sample Size’ calculation 
programme7.  
 
Type I error (α) risk  
In each of the two RCTs we wish to conduct multiple comparisons (between 3 groups), and hence 
significance level must be as follows, due to Bonferroni correction: 
𝛼=
0,05
3 =
1
60 = 0,0167 
 
Type II error (β) risk 
The organizational constellation of the interventions has not yet been trialled, and thus the desired 
power shall be set to: 𝛽= 0,9 
 
If it turns out that we cannot include enough participants, the power could be set to:𝛽= 0,8 
 
Hazard ratio (R) 
The mean difference in time for return to work will be calculated as a hazard ratio. We estimate 
that as sufficient HR is 𝑅= 1,5 
since just 50 % faster return to work time in the intervention groups will convey a relevant 
economic benefit, due to the hence smaller loss of productivity. 
 
Mean time to return to work (M1) 
Number of days from baseline to return to work is conservatively estimated to be 210 days, after an 
observed range from 104 to 210 days, in the control groups in three Dutch RCTs (Suzanne E. 
Lagerveld et al., 2012; Oostrom et al., 2010; Vlasveld et al., 2013), which were comparable to the 
control groups in the IBBIS RCTs. Hence, 𝑀1 = 210 
 
Inclusion time period (A) 
We will include participants through 24 months,𝐴= 730[𝑑𝑎𝑦𝑠] 
Ratio between groups (m) 
• 
Ratio is 1:1:1, and hence m = 1 
Follow-up time (F) 
We will follow participants up for 365 days, in which they will contribute with risk time in the 
survival analysis, hence F = 365 
Result 
In each group, due to the above-mentioned variables, we need 
 
198 participants per group, and with two RCTs both including three groups that 
yields a need for, with power = 0.9 
 
𝑁= 198 
participants
groups
× 3
groups
trial × 2 trials = 1188 participants 
 
If, in case of insufficient inclusion possibilities, power could be lowered to 0,8. In such case we would 
need the following number: 
 
                                                        
7 http://ps-power-and-sample-size-calculation.software.informer.com  

 
48 
 
𝑁= 153 
participants
groups
× 3
groups
trial × 2 trials = 918 participants 
 
4.2.6.2 Power estimations, secondary outcomes 
 
Table 9: Power estimations for secondary outcomes 
 
Binary 
secondary 
outcomes 
Expected 
proportion 
in control 
group 
Expected 
proportion in 
intervention 
group 
α- 
signi-
ficance 
level 
Power 
Test 
References 
Proportion 
achieving more 
than four weeks 
of ordinary job 
0,65 
0,80 
0,0167 
0,838 
2-test 
(Suzanne E. 
Lagerveld et al., 
2012; Oostrom et al., 
2010; Søgaard & 
Bech, 2009; Vlasveld 
et al., 2013) 
Proportion of >4 
weeks sick 
absentees 
among 
participants who 
returned to 
work, after 24 
months 
0,19 
0,09 
0,0167 
0,692 
2-test (Koopmans et al., 
2011) 
 
Table 10: Power estimates for secondary continuous outcomes 
Outcome 
δ 
clinically 
relevant 
difference 
in mean 
σ expected 
standard 
deviation 
α 
 
Power 
Test 
Reference 
Difference in depressive 
symptoms measured by 
Beck Depression 
Inventory (BDI)  
4 
11 
0.0167 
0.893 
t-
test 
(Buszewicz, 
Griffin, 
McMahon, 
Beecham, & 
King, 2010; 
König et al., 
2009; Mann 
et al., 1998; 
Muntingh et 
al., 2009; J 
Proudfoot et 
al., 2003; 
Judith 
Proudfoot et 
al., 2004) 
Difference in anxiety  
symptoms measured by 
Beck Anxiety Inventory 
(BAI)  
4 
12 
0.0167 
0.826 
t-
test 
Difference in stress 
symptoms measured by 
Cohen perceived stress 
scale (PSS)  
5 
8 
0.0167 
1.000 
t-
test 
(Ejeby et al., 
2014; 
Lengacher et 
al., 2009; 

 
49 
 
 
 
In accordance with the CONSORT guidelines, the analysis for all outcomes is analysed according to 
the intention-to-treat principle. 
4.2.6.3 Statistical analysis of primary outcome 
The primary outcome is the time from baseline to return to work, as measured after 12 months 
from baseline, data is obtained from the DREAM register and is therefore expected to be complete. 
The effect of the specific trial interventions, mental health care, and integrated mental health care 
and vocational rehabilitation respectively, will be analysed by cumulated incidence analysis (also 
known as survival analyses, often depicted as Kaplan-Meier curves). Cox regression-analyses will 
be utilized to compare the three groups, and relevant factors will be involved as co-variates. 
4.2.6.4 Statistical analysis of secondary outcomes 
The RCT- studies’ secondary outcome, time from return to work date to subsequent sick leave, will 
be analysed for the group who has returned to work after one year. This will be analysed similarly 
to the primary outcome, through cumulated incidence analysis. 
 
Five of the secondary outcomes are continuous: it is the four instruments BDI, BAI, PSS and WSAS 
and the outcome number of weeks in work. These will be analysed with repeated measurement 
model in mixed model analyses with unstructured variance. The prerequisite for using this 
analysis and the use of multiple imputations is that the data is missing at random or missing 
completely at random unlike non-ignorable non-response. This distinction is important since 
repeated measurement and multiple imputations are both models based on a statistical estimation 
of non-existing answers, and the premises for these estimations must be present for the analysis to 
be valid. 
 
The dichotomous secondary outcome proportion at work will be analysed with logistic regression. 
Here too, multiple multivariate imputations will be used and all co-variate with presumed 
prognostic significance will be used to impute a distribution of missing data. 
 
We will analyse whether the conditions for the use of repeated measurement and multiple 
imputation is present by conducting a drop-out analysis. Significant prognostic characteristics of 
patients that cannot be followed up will be compared with those patients who exhibit adherence to 
the study. Variables showing a difference between participants and non-participants will be 
included as co-variates in the analyses. Data analysis will be based on the intention-to-treat 
principle. Data from all patients will be included corresponding to the group to which they have 
been randomly allocated. 
 
 
 
 
Willert, 
Thulstrup, & 
Bonde, 2011) 
Social and work related 
function measured by 
WSAS 
4 
10 
0.0167 
0.946 
t-
test 
(Phillips et al., 
2014) 

 
50 
 
4.3 COST-EFFECTIVENESS STUDY 
 
The aim of this study is to calculate the cost-effectiveness of the IBBIS interventions in the two 
RCT-studies. The cost-effectiveness study is sent in tender and will be carried out by researchers 
with expertise in this field.  The cost effectiveness study will focus on two outcome measures: 
quality adjusted life years (QALY) and return to work (RTW).  
 
QALY's are a measure used in health economic evaluations across countries and diseases. QALY's 
are calculated by multiplying the survival time with a health-related target. RTW in economic 
evaluations is typically measured in two ways: Number of days for return to work, or number of 
days in work over a 12-month period or longer. In this study, it is most appropriate to use the latter 
goal, as too fast return to work implies a risk of rapid sick leave. Two analyses are performed per 
intervention-arm (in both RCT-studies).  The analysis of the QALY corresponds to the timeline of 
the RCT study, but for the return to work-analysis, a decision on a specific follow-up period will be 
made.  
 
All costs are measured on an individual level and include costs both from the health and labour 
market. Costs are divided into intervention costs, which are costs from the intervention itself (e.g. 
time used for therapy); derived costs, which are costs from hospitalization, medication etc.; lost 
productivity, measured as labour market affiliation and lastly derived municipal costs. 
 
A comparison is based on the incremental cost-effectiveness ratio, ICER, which is a measure of how 
much it costs to obtain an additional QALY. 
 
4.4 PROCESS EVALUATION STUDY 
4.4.1 INTRODUCTION 
The IBBIS interventions are highly complex as they involve a high number of groups and 
organizations, a high number of new skills and behaviours are required by the professionals 
delivering the intervention, a high number of intermediate outcomes (addressing both work status, 
health status, quality of life and functioning), and a high degree of flexibility and tailoring of the 
intervention (Hansen & Tjørnhøj-Thomsen, 2015; G. Moore et al., 2015). 
The aim of the RCTs is to examine whether or not the compounded complex interventions have an 
effect on return to work. The RCTs will provide little knowledge about why the interventions did or 
did not improve return to work compared to standard interventions. Process evaluations are highly 
relevant in order to understand the implementation and functioning of complex interventions 
(Linnan & Steckler, 2004; G. F. Moore et al., 2015a), which has been relevant on similar complex 
return to work-interventions internationally (Arends et al., 2014) and Danish municipalities (Aust 
et al., 2015; Martin, Nielsen, Petersen, Jakobsen, & Rugulies, 2012). Theoretically, implementation 
of interventions can be considered “a social process that is intertwined with the context in which it 
takes place” (Hansen & Tjørnhøj-Thomsen, 2015). Because implementation of an intervention 
differs in different contexts it is valuable to conduct a process evaluation which can qualify the 
generalizability (external validity) of the results from the effect evaluation, by describing the 
conditions under which the intervention worked or did not work (Hansen & Tjørnhøj-Thomsen, 
2015). Thus, the process evaluation can provide important knowledge for a possible 
implementation of the IBBIS interventions in other Danish municipalities.  
 

 
51 
 
Whereas the fidelity reviews will give a cursory description of a broad range of elements in the 
IBBIS intervention, the process evaluation will provide in-depth knowledge about two selected core 
elements of the intervention: 
 
1) Relational coordination between professionals in the cross-disciplinary teams to create 
coherent mental health care and vocational rehabilitation courses for the participant 
2) Person-centred interventions through shared decision making (SDM) between the citizen, 
employment consultant, and the care manager  
4.4.2 METHOD 
The process evaluation is designed to accommodate the guidelines of the British Medical Research 
Council for evaluation of complex interventions (G. F. Moore et al., 2015b) and takes a realist 
evaluation perspective on the integration of knowledge from the RCTs and the process evaluation 
(Bonell, Fletcher, Morton, Lorenc, & Moore, 2012).  
 
Moore and Colleagues suggest that process evaluations are designed to describe the 
implementation of the intervention, the mechanisms by which these interventions are expected to 
produce change for the target group and the contextual factors which influence the implementation 
and mechanisms as just described (G. Moore et al., 2015). These core elements of a process 
evaluation are described in Figure 6. 
 
Figure 6: Core elements in process evaluations according to Moore et al. 
 
 
The evaluation process was initiated with the production of a logic model for the three IBBIS 
interventions after examination of the IBBIS intervention in three steps: 
 
• 
Reading intervention material; 72 manuals, appendix’ and worksheets 
• 
Producing basic logic models about IBBIS interventions and implementation activities 
• 
Consensus on logic models and key uncertainties through workshops with interventions 
designers(G. Moore et al., 2015) 
 

 
52 
 
Only the integrated mental health care and vocational rehabilitation intervention was selected for 
process evaluation and the three above mentioned themes was chosen from this intervention. 
Specific middle range theories where designed for the three core elements of the IBBIS 
intervention. The process evaluation will be performed as three separate studies each with the use 
of multiple research styles (Hansen & Tjørnhøj-Thomsen, 2015).   
 
The roundtable meeting is of central interest as it is the empirical outset for our empirical material. 
The meeting is described in the IBBIS intervention as a starting point for the collaboration between 
professionals and the participant. All three parties are present during the meeting where the joint 
goals regarding treatment and vocational rehabilitation are decided and turned into a joint plan for 
the participants’ return to work process.  
 
From this empirical starting point, the roundtable meeting, the studies investigate the perspectives, 
efforts and context of the sick leave beneficiaries receiving the IBBIS service and the 
multidisciplinary team providing the service, respectively.  The latter has a particular focus on the 
care managers (CM) and the employment consultants (EC), who are the primary service providers. 
In the following section, the methods applied in the two studies are described more specifically and 
related to the three components of the process evaluation – implementation, mechanism of impact 
and context.  
 
We will use 1) observations of roundtable meetings 2) individual interviews with participants, care 
managers, and employments consultants, and 3) focus group discussions (FGD) with care 
managers and employments consultants, and 4) quantitative data from registration sheets 
regarding provision of roundtable meetings for these studies.  
 
Our research questions are divided into sub-questions which are described under each study and 
implementation, mechanisms of impact and contextual factors respectively. 
 
Sub-studies 
1) Implementation  
 
2) Mechanism of impact  3) Contextual factors  
 
1) Shared decision 
making between 
the 
interdisciplinary 
teams and the 
citizens  
 
 
Observations 
(n=24) 
 
Telephone interview 
(n=12) 
 
Follow-up interview 
(n=8) 
 
FGD 
(n = 8 CM) 
(n = 8 BK) 
 
How is SDM practiced 
in the roundtable 
meeting? 
 
 
 
Observations 
Are principles of SDM 
practiced according to 
OPTION scale? 
 
Telephone interview 
(C) 
How have citizens 
experienced their 
partaking in decisions 
in the roundtable 
meeting?  
 
FGD (CM/ES) 
How do team members 
experience the 
possibilities of 
practicing SDM? 
How does the process of 
SDM and the agreed 
decisions made (the 
common plan) impact on 
citizens’ return to work? 
 
Follow-up interviews 
(c) 
How have citizens managed 
to put the common plan 
into practice in their 
everyday lives? 
-challenges 
-success 
-modifications 
How do contextual factors 
influence the common plan 
and how has the common 
plan influenced the 
context? 
 
Follow-up interviews 
(c) 
How have the citizens’ life 
conditions, workplace etc. 
influenced the execution of 
the common plan? 
 
How has the common plan 
influenced life conditions, 
relations, and workplace? 
 
FGD (CM/EC)  
How has contextual factors 
(legal, organising, design) 
influenced the possibilities 
of SDM/ making common 
plans? 
 

 
53 
 
 
(How has working with 
SDM/common plans 
influenced organisational, 
professional context?)  
2) Relational 
coordination 
between 
professionals in 
interdisciplinary 
teams through 
roundtables 
 
Observations of 
roundtables with CM, 
EC, and the 
participant 
(n=12) 
 
Personal interviews 
with CM 
(n=12) 
 
Personal interviews 
with EC 
(n=12) 
 
 
How, when, and how 
often are the 
roundtables conducted 
to create shared goals? 
 
Registration sheets 
How many participants 
have a roundtable? 
When are the 
roundtables conducted? 
How long are the 
meetings? 
How many roundtables 
are conducted for each 
participant? 
 
Observations 
Are the roundtables 
conducted with fidelity 
to the manual and the 
work sheet? 
How are the roundtable 
used to produce shared 
goals? 
How is shared 
knowledge produced or 
used at the roundtable? 
How does the CM and 
EC present respect for 
each or other? 
 
 
Interviews with CM 
and EC 
How do the 
professionals 
experience the 
production of shared 
goals with the 
participants? 
How do the 
professionals 
experience their 
collaboration with the 
other professional at 
the roundtable? 
 
How do the roundtables 
enhance the integration of 
services? 
 
Observations 
What is coordinated? 
What happens if there are 
discrepancies between the 
professionals and/or the 
participants’ wishes and 
recommendations? How 
does alignment take place? 
 
Interviews with CM and 
EC 
How do the CM and EC 
experience the coordination 
of services at the meeting? 
How do the organizational 
context of CMs and ECs 
influence the collaboration 
(and if possible the 
integration of services) ? 
 
Observations 
How is the structure of the 
meeting and the decisions 
negotiated at the 
roundtables? Which 
positions do the CM and EC 
take?  
How is the job center and 
legislation mentioned at the 
roundtable? 
 
 
Interviews with CM and 
EC 
Which external factors 
influence the collaboration 
between CM and EC and 
thus, the respect, shared 
knowledge and shared 
goals? 
 
 

 
54 
 
4.4.3 DISCUSSION 
A critique of the process evaluation is that its findings can be difficult to generalize, because it 
investigates the complexities of local context and relations. However, in our design, we have 
focused on theoretical aspects of the intervention (e.g., shared decision making and relational 
coordination). By focusing on how these theories are put into local practice, we not only provide 
insight into the local circumstances of the IBBIS intervention but contribute to the broader 
theoretical discussion of these theories. The results of the process evaluation will thus both 
contribute to implementation research regarding the empirical field of sick leave beneficiaries 
return to work and contribute to the theoretical field of shared decision making and relational 
coordination, which expands beyond the empirical field. 
4.5 PREDICTORS FOR RETURN TO WORK STUDY 
4.5.1 BACKGROUND 
When sick due to common mental disorders (or other disorders), it is common practice in 
Denmark, that the GP or other healthcare professionals make an estimate of the expected sick leave 
period. Clinicians sometimes stress difficulties in making precise judgments on the length of a sick 
leave period for people with mental disorders, and they wish to have more precise knowledge or 
instruments to predict the length of a sick leave period. 
 
Currently, research points at different factors in different domains that might predict the length of 
a sick leave period. Some studies indicate that illness-related factors like diagnosis or symptom 
severity is a predictor (Dewa et al., 2011; S. E. Lagerveld et al., 2010; Nieuwenhuijsen et al., 2006). 
Psychological factors like return to work expectations seems to be a factor, which can predict the 
length of the sickness period (Brouwer, Reneman, Bültmann, Van Der Klink, & Groothoff, 2010) 
(Pedersen, 2016). The concept of self-efficacy, defined either as a general belief that one's actions 
are responsible for successful outcome (Schwarzer & Jerusalem, 1995),  or specified to certain 
domains, e.g. return to work self-efficacy (Brouwer et al., 2011) or illness perception (Weinman, 
Petrie, Moss-Morris, & Horne, 1996) might be a potential predictive factor to investigate further.  
 
The purpose of the predictors for return to work study is to investigate factors at baseline, which 
can predict return to work. If GPs or clinicians in mental health institutions acquire more 
knowledge about factors that typically do or do not influence the length of a sick leave period 
(caused by common mental disorders), it will likely improve their clinical estimates of a citizen’s 
sick leave period.  
4.5.2 METHODS 
The predictors for return to work study is based on the research question: 
 
‘Which factors at baseline predict return to work to for people on sick leave due to common 
mental disorders?’  
 
The study contains two parts: 
- 
A structured literature review 
- 
An analysis of predictors for return work in the IBBIS sample. 
4.5.2.1 Structured literature review 
The aim of the structured literature review is to search for predictors or prognostic factors for 
return to work in the research literature. This will be done by searching the following databases for 
relevant literature: PubMed, PsycINFO, Cochrane, Cinahl, Embase, ProQuest and Web of Science.  

 
55 
 
4.5.2.1.1 Inclusion criteria & exclusion criteria 
 
Studies included should: 
- 
Have participants with anxiety disorders ranging from F.40-F.41.9 in ICD-10 or 
- 
Have participants with depressive disorders, ranging from F.32.0- F.39.0 in ICD-10 or 
- 
Have participants with stress-related disorders, either F.43.0 or ranging from F.43.2-
F.4329 in ICD-10 or labeled non-diagnostic terms as stress, distress, burn-out or 
exhaustion disorder 
- 
Search for predictors or prognostic factors for return to work, work ability, work function, 
rehabilitation, presenteeism and absenteeism 
Studies will be excluded if: 
 
- 
They are not able to adequately distinguish between results for different diagnosis (e.g. 
unipolar vs. bipolar depression)  
4.5.2.2 Predictors for return to work - in the IBBIS sample 
 
Citizens that are eligible for referral to the IBBIS mental health assessment are asked to complete 
an online questionnaire providing data regarding psychiatric symptoms e.g. depressive symptoms 
according to the BDI(Aaron T Beck et al., 1988) or stress symptoms according to Cohens Perceived 
Stress scale (PSS) (Cohen et al., 1983). Likewise, participants in the IBBIS-project provide other 
self-report and register data within domains like quality of life, self-efficacy or demographic data. 
Thus, data for this study is collected through the data collection for the RCT-studies, providing 
baseline data from 1188 participants. The study will either analyse predictors in the RCT-groups 
(Control group, mental health group, integrated group) by cox regression analysis or do analysis of 
trajectories in the RTW process. This part of the study is yet in the preparation and design phase. 
 
If the results of this study are in line with some other studies pointing to return to work-self-
efficacy as an important predictor for return to work, the study will include a discussion of the 
concept and its implications. 
 
 
 
 
 

 
56 
 
5 ETHICAL CONSIDERATIONS  
A general ethical consideration behind the IBBIS-project is a paradox between a political decision 
to make health care treatment available in a free and equal fashion, for all citizens, and on the other 
hand analyses showing that this is in fact not happening, as previously described. Hence, in order 
to achieve the politically formulated goal in the legislation regulating the health care system in 
Denmark8, steps must be taken. One of the obstacles is seemingly a lack of integration  and timely 
referral between municipal job centre, who is responsible for case handling of sick leave benefit 
recipients, primary care, and regional mental health care centres (OECD, 2013). This project 
investigates an innovative way of organizing the integration of the interventions from the relevant 
sectors. 
 
5.1 COMPETING INTERESTS 
The researchers have no competing interests to declare. 
 
The project is primarily funded by The Danish Agency for Labour Market and Recruitment. The 
agency has had a role in the design of the study (co-responsible for the selection of the target 
population and the design of selected interventions modalities). The funding agency will not take 
part of decisions regarding analysis, interpretation of the data, or publication of results. 
 
5.2 OFFICIAL APPROVAL  
The studies in the IBBIS project will be conducted in compliance with this protocol, the Helsinki 
Declaration in its latest form, good clinical practice guidelines, and national legislation on data 
management. The trial has been evaluated by the Regional Ethics Committees of the Capital 
Region of Denmark (# H-16015724), but the trial was not judged to be a biomedical trial and the 
need for ethical approval was waived. The protocol is registered on www.clinicaltrials.gov (# 
NCT02885519 and # NCT02872051), and any changes in the intervention or design will be 
submitted to the website. The Danish Data Protection Agency has approved the project, and it will 
be conducted in accordance with Danish data protection legislation. 
 
The municipal case workers, who inform the participants, will have received enough information to 
sufficiently inform citizens about the psychiatric assessment study. This is ensured through regular 
briefings and distribution of written information to the involved municipal job centres. Likewise, 
care managers and other assessors, informing about the randomised controlled trials are prepared 
to inform sufficiently about the studies. 
 
5.3 PARTICIPATION 
Every participant in the trial has been informed about the objective of the study and the 
implications of participation by an IBBIS team member and has given oral and written consent to 
participate before enrolment. Potential participants are informed about expected risks and benefits 
from participating in the studies.  
 
 
                                                        
8 https://www.retsinformation.dk/forms/r0710.aspx?id=152710  

 
57 
 
Participants will receive both written and verbal information about the relevant RCT and both oral 
and written consent is mandatory to participate in one of the RCT studies. Essential information on 
the following topics will be provided by the IBBIS health care professional immediately following 
the mental health assessment interview:  
 
• 
Objectives and methods of the project 
• 
Randomization to three interventions as described in figure 5  
• 
Expected duration of the intervention 
• 
Expected number of contacts and duration of these contacts  
• 
Pros and cons of participation 
Participation in the RCT studies is voluntary. Participants will be informed about their rights to 
withdraw from the study at any point and without consequences for their future treatment. If 
withdrawing, participants can decide how much information can be used in the study. Participants 
are informed that there are no expected side effects of the interventions and that he or she can 
withdraw from the study at any time without any consequences for future treatment, vocational 
services or social benefits.  
The participant is informed that she or he can bring a relative to an additional information meeting, 
where an IBBIS team member will inform about the assessment and the implications for the 
participants and that she or he has the opportunity for a 24 hour reflection period before the decision 
to participate has to be made. 
By consenting to participate in one of the RCT studies, the participant also consents to participate in 
related projects, e.g. the cost-effectiveness study and the process evaluation. 
5.3.1 WITHDRAWAL FROM THE RESEARCH STUDIES 
A participant in the IBBIS project can discontinue from the interventions and withdraw consent to 
participate in subsequent questionnaires at all times. A participant who no longer wishes to 
participate in one of the trials can withdraw his/her informed consent at any time without the need 
of further explanation, and this will not have any consequences for the participant’s further 
treatment.  
 
A participant who wants to withdraw from the allocated intervention has the following 
possibilities:  
 
1. The participant will receive the subsequent follow-up questionnaires after the time of 
withdrawal. Data collected before that date will be analyzed.  
2. The participant will NOT receive the subsequent follow-up questionnaires after the time of 
withdrawal, but register data will be collected and analyzed. Data collected before that date 
will be analyzed.  
3. The participant will NOT receive the subsequent follow-up questionnaires after the time of 
withdrawal and register data will NOT be collected and analyzed. Data collected before that 
date will be analyzed. 
4. The participant will NOT receive the subsequent follow-up questionnaires after the time of 
withdrawal and register data will NOT be collected and analyzed. Data collected before that 
date will be deleted. 
 

 
58 
 
5.4 ADVERSE EFFECTS FROM THE IBBIS INTERVENTION 
Interventions similar to the IBBIS interventions have not previously shown increased risk of 
adverse effects. Symptom severity and suicidal ideation are nonetheless monitored by Care 
Managers with psychometric instruments assessing symptoms of depression, anxiety and stress. 
Monitoring of symptoms will take place every second week throughout the mental health care 
intervention to make sure deterioration in the participant’s condition will be accommodated.  
 
Starting work can be stressful for some participants. If return to work takes place during the 
intervention period, participants will be monitored closely by the involved IBBIS team member. 
 
We will assess adverse effects from the IBBIS interventions by analysis of 
 
• 
Symptoms with 4DSQ (Terluin et al., 2006a) at 6, 12 and 24 month follow-up 
• 
Relapse at 24 months follow-up 
• 
Suicidal thoughts, plans or actions assessed using the BDI at 6, 12 and 24 months 
• 
Death (natural, accident, suicide, homicide, violence or unknown): Obtainable at Death 
Register 6, 12 and 24 months after baseline 
• 
Life-threatening conditions for reasons other than suicide 
 
Besides the general ethical considerations there are specific ethical considerations in some studies: 
 
5.5 ETHICAL ISSUES REGARDING THE MENTAL HEALTH 
ASSESSMENT STUDY 
 
The main ethical considerations of the mental health assessment study are the following issues: 
 
1) Time consumption for the individual  
2) Risk of different assessment results  
3) Risk of incorrect assessment results  
 
Reg. 1) 
Most individuals have already received a medical evaluation by their GP and will have to spend an 
hour completing the assessment questionnaires and several hours on the assessment interview 
with the assessor. Some individuals may find this troublesome and perhaps even stressful. Yet, we 
do not consider it to pose any mental health risk. 
 
Reg. 2) 
Some individuals might be assessed differently in the IBBIS mental health evaluation, than how the 
GP assessed them, conveying possible frustration. Yet, we strive to maintain a high level of 
professional standards, by continuous training and supervision of assessors. Furthermore, in this 
training, we emphasize the importance of thoroughly explaining the possible difficulties and 
uncertainties in diagnosing mental health disorders, hopefully entailing an understanding and 
hence acceptance of such assessment result differences. 
 
Reg. 3) 
There is a risk of incorrect diagnosing in all mental health assessment, as well as almost all other 
medical assessments. We do not consider this risk as being higher in the IBBIS mental health 

 
59 
 
assessment than what individuals might otherwise be exposed to.  
 
5.6 ETHICAL ISSUES REGARDING THE PREDICTORS OF RETURN 
TO WORK STUDY 
 
The predictors for return to work study investigates both intrapersonal factors like self-efficacy or 
quality of life, sociodemographic factors like levels of education or work-related factors as possible 
predictors for return to work. There are ethical considerations with regard to the individuals own 
responsibility to be able to return to work, if predictive factors are mainly interpersonal. These 
results could possibly impose an unsound pressure from work place or employment consultants on 
the individual, already having difficulties related to their mental health condition.  
 
 

 
60 
 
6 TRIAL TIMELINE, PLAN FOR PUBLICATION, AND 
DISSEMINATION 
 
The timeline for the preparation, data collection and publication of the IBBIS studies is described 
below. 
 
The Mental Health Assessment study 
 
Preparation and design: January 2016 – February 2018 
Data collection: March 2016 – March 2019 
Analysis and publication: April 2018 – July 2019 
 
RCT 1 and RCT 2  
 
Preparation and design: August 2015 – March 2016 
Data collection: April 2016 – April 2020 
Analysis and publication: May 2018 – October 2020 
 
Results from 6-, 12- and 24-month follow-up will be published in international journals and in two 
Ph.D.-theses. Positive, as well as negative and inconclusive results will be published. 
 
Process Evaluation Study 
 
Preparation and design: August 2016 – February 2017 
Data collection: March 2017 – July 2018 
Analysis and publication: August 2017 – July 2019 
 
Cost-Effectiveness study 
 
Preparation and design: February 2016 – April 2019 
Data collection: April 2016 – April 2020 
Analysis and publication: July 2019 – September 2020 
 
Predictors for return to work study 
Structured literature review: 
Preparation and design: March 2017 – September 2017 
Data collection: October 2017– May 2018 
Analysis and publication: June 2018 – October 2018 
 
Predictors in the IBBIS sample: 
 
Preparation and design: June 2018 – March 2019 
Data collection: April 2016– March 2018 
Analysis and publication: April 2018 – July 2018 
 

 
61 
 
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8 PROTOCOL REVISION HISTORY 
Version 1 was a study protocol in Danish language, finished prior to inclusion, commencing spring 
2016. Two study design articles were published in July 2017(Poulsen et al., 2017a; Poulsen, Fisker, 
Hoff, Hjorthøj, & Eplov, 2017b), referred to as a “Version 2” of the study protocol on the official 
organization’s webpage9. 
Version 3 (~3.0) was an updated version of Version 1 (in English language), finished and published 
in March 2018. 
 
This Version 3.1 is similar to Version 3.0, with only correction of language, links and lay-out, etc., 
published on clinicaltrials.org in July 2019, approx. simultaneously with the detailed Statistical 
Analysis Plan [version 1.0]. 
                                                        
9 https://www.psykiatri-regionh.dk/Kvalitet-og-udvikling/udvikling/ibbis/Sider/IBBIS-forskning.aspx