Thesis

Illness Management and Recovery Implementation and Effects Bert-Jan Roosenschoon

Illness Management and Recovery Implementation and Effects Bert-Jan Roosenschoon

Colophon Most of this study was supported by Parnassia Psychiatric Institute and the Parnassia Academy (The Hague/ Rotterdam), in cooperation with the Epidemiological and Social Psychiatric Research Institute (ESPRi), part of the department of Psychiatry of Erasmus Medical Center Rotterdam. Part of this study was funded by an unconditional educational grant from Janssen-Cilag B.V. The funders had no role in study design, data collection, analysis, and interpretation, the decision to publish, or the preparation of the manuscript. Cover: Olive Trees with yellow sky and sun - Vincent van Gogh, Saint-Rémy, November 1889. The Minneapolis Institute of Arts/ van goghgallery.com. Source/ Photographer: rwGVxwlplhHn6g at Google Cultural Institute Publisher: Parnassia Groep Den Haag ISBN: 978-90-77877-30-2 Printed by: Ipskamp Drukkers B.V. © Bert-Jan Roosenschoon 2024

Illness Management and Recovery Implementation and Effects Eigen Regie en Herstel Implementatie en Effecten Thesis to obtain the degree of Doctor from the Erasmus University Rotterdam by command of the rector magnificus Prof.dr. A.L. Bredenoord and in accordance with the decision of the Doctorate Board. The public defence shall be held on Tuesday sept 3 2024 at 13.00 hrs by Bert-Jan Roosenschoon Geboren te Utrecht

Doctoral Committee: Promotors: Prof. dr. C.L. Mulder Prof. dr. J. van Weeghel Other members: Prof. dr. J.J. van Busschbach Prof. dr. S. Castelein Prof. dr. J.D. Kroon Copromotor: Dr. A.M. Kamperman

Contents Chapter 1 General introduction 7 Chapter 2 lllness Management and Recovery (IMR) in the Netherlands; 33 a naturalistic pilot study to explore the feasibility of a randomized controlled trial Chapter 3 Effectiveness of illness management and recovery (IMR) in 63 the Netherlands: a randomized clinical trial. Study protocol Chapter 4 Determinants of clinical, functional, and personal recovery 85 for people with schizophrenia and other severe mental illnesses: A cross-sectional analysis Chapter 5 Effects of Illness Management and Recovery: a multicenter 107 randomized controlled trial Chapter 6 Fidelity and clinical competence in providing Illness 141 Management and Recovery: an explorative study Chapter 7 Illness (self) management, clinical, and functional recovery 167 as determinants of personal recovery in people with severe mental illnesses: a mediation analysis Chapter 8 General discussion 187 English summary 209 Dutch summary (samenvatting) 223 Portfolio 239 Dankwoord 257 Curriculum Vitae 263

CHAPTER 1 General introduction CHAPTER 1 General Introduction

Chapter 1 8

General introduction 9 Introduction This introductory chapter reviews various aspects and themes related to the main subject of this dissertation. The focus is on the origins of Illness Management and Recovery (IMR). Particularly in the United States, after the deinstitutionalization of large state hospitals, many outpatient care innovations emerged for people with severe and persistent mental illness (SMI) under the heading of community care. An increasing number of these innovative outpatient services were based on two principles: the use of recovery orientation and demonstrated evidence for effectiveness. Long-term care, illness management, rehabilitation, and recovery Epidemiology People are regarded as having SMI if they have a long-term psychiatric disorder that involves serious impairments in social and/or community functioning requiring multidisciplinary professional care to achieve a treatment plan. These impairments are both cause and effect (1). SMI is not diagnosis specific. Most people with SMI (60%) are diagnosed with schizophrenia or other psychotic disorders, 10% have a primary diagnosis of substance addiction, and 30% have another primary diagnosis (1). SMI also includes diagnoses such as bipolar disorder and major depression, and comorbid disorders are often present such as addiction, personality disorder, or pervasive developmental disorder (1). Comorbidity with physical diseases also occurs, including cardiovascular diseases, diabetes, cancer, and obesity (2). These physical diseases may substantially reduce life expectancy (3). In 2017, the prevalence of SMI in the Netherlands was estimated to be 1.7% of the population (~281,000 people). Of these individuals, approximately 210,700 are under care (4). New perspectives for people with SMI People with schizophrenia and other SMIs face major challenges in achieving their personal goals and fully participating in society. Although they have the same aspirations as others, their wishes are more difficult to realize because of recurring symptoms, cognitive impairment, loss of social support, and societal barriers such as stigma (5, 6). For a long time, people with SMI were thought to have little chance for improvement. Many relied on long-term stays in psychiatric hospitals. However, by the 1970s and 1980s, the mental health paradigm changed to deinstitutionalization and community care.

Chapter 1 10 Moreover, during the 1980s and 1990s, the recovery movement arose (7) that originated largely from client advocacy, including some impactful testimonials from experts by experience. The guiding vision then became psychiatric rehabilitation, the goal of which was “to help disabled individuals to develop the emotional, social and intellectual skills needed to live, learn and work in the community with the least amount of professional support” (8). Subsequently, the concept of rehabilitation evolved into recovery. William Anthony defined recovery as “a deeply personal, unique process of changing one’s attitudes, values, feelings, goals, skills, and/or roles. It is a way of living a satisfying, hopeful, and contributing life even with limitations caused by the illness. Recovery involves the development of new meaning and purpose in one’s life as one grows beyond the catastrophic effects of mental illness. Recovery from mental illness involves much more than recovery from the illness itself”(9). Currently, most mental health services aim to support the individual recovery processes of people with SMI (7). Various treatments are currently available for people with SMI. Often, the treatment includes the use of pharmaceuticals, which facilitate the reduction of symptom severity and relapse. In addition, evidence-based psychotherapeutic treatments are available, such as cognitive behavioral therapy (CBT), eye movement desensitization and reprocessing (EMDR), prolonged exposure therapy (PE), and trauma-focused therapies (10). However, applying these treatments with high fidelity is challenging (11). Additionally, effective psychosocial recovery interventions for participants in illness self-management and recovery are needed. The aim of these interventions is to improve the self-management of symptoms, relapses, and stresses in everyday life to develop hope and optimism for the future and facilitate recovery. In recent years, in the Netherlands, various innovative psychosocial interventions have been implemented to support the recovery of people with SMI, such as the Boston Psychiatric Rehabilitation Approach (12), Wellness Recovery Action Plan (WRAP) (13), cognitive adaptation training (CAT) (14), the active recovery triad model (ART) (15), peer-supported open dialogue (POD) (16), and resource groups (17). Drastic deinstitutionalization in the US evoked need for community care Originally, mental health care in most countries consisted primarily of inpatient care in psychiatric hospitals. In the United States, most state hospitals were founded in the mid-19th century, mainly providing custodial care (18). Around 1955, deinstitutionalization began, prompted by new medications and federal policies. Deinstitutionalization in mental health care refers to the process of

General introduction 11 moving away from the use of large, centralized mental institutions toward community-based care for individuals with mental illness (18). In the 1960s and 1970s, the civil rights movement fostered deinstitutionalization. Reports of frequent coercive interventions in hospitals influenced public opinion and led to the closure of psychiatric hospitals. In addition, outpatient treatment and drug therapy were cheaper than hospital care (19). However, deinstitutionalization in the United States occurred too rapidly. Sufficient alternatives to hospitalization were not available. Because many psychiatric patients lacked family ties and experience with independent living, many ended up homeless or in community-based sheltered care such as halfway houses, family care homes, board-and-care homes, nursing homes, or even jail (20, 21). The quality of these homes varied widely (18). Sometimes, there were calls for a new asylum (19). After deinstitutionalization, there was a great need for high-quality outpatient services. In the mid-1970s, in response to this need, the concept of a Community Support System (CSS) emerged. A CSS refers to “a coordinated network of persons, services and provisions organized at a regional level, in which persons with SMI themselves take part and which provides many different means of support in their attempts to take part in the community”(8, 22, 23). Relevant CSS components include rehabilitation services, housing, family and community support, peer support, mental health treatment, and crisis response services (8). For social integration, other important functions of CSS are learning self-management, including coping skills, social skills training, connecting with people at meeting places, practical assistance such as income support, and educating the public to overcome stigma (22). The United States as a trendsetter for innovations in community care It appeared that central government-imposed deinstitutionalization initially led to many challenges in the United States but also in other countries such as the United Kingdom (24) and Italy (25). However, especially in the United States, it encouraged creative innovations to CSSs. In the late 20th century, various care innovation projects emerged to provide adequate community mental health care to people with SMI (26). Inspired by these American models, many innovations were implemented in the Netherlands. Initially, in addition to supportive housing (27, 28), case management played a central role (7, 29-31). For the substitution of psychiatric hospitals, day hospitals were introduced (32-34). To provide relevant daily activities, club-houses (35-38) and supportive employment projects were started (39).

Chapter 1 12 In the Netherlands, there were no plans for the mass discharge of patients or closure of institutions. Initially, there was only a slight and gradual reduction in the number of beds in psychiatric hospitals (40). However, the number of beds has decreased significantly in recent years. Two requirements for innovations in community care: recovery and evidence-based Several well-designed community-based programs have been developed to improve the mental health care system. These proposals for improvement were based on two principles: (1) the use of a recovery paradigm to guide service delivery and (2) the implementation of services that have been shown to be effective in improving patient outcomes (41). These two principles are discussed briefly in this section. (1) What is recovery? In recent years, the concept of recovery has become increasingly important and has generated interest and optimism among various stakeholders, such as service users, providers, and insurance companies (42). Previously, the term rehabilitation was used (8). However, the relationship between consumers and practitioners has been fundamentally redefined. Rehabilitation refers to what clinicians do and recovery refers to what consumers do. Clinicians support consumer recovery on an equal basis (43). Therefore, treatment success in mental health care for people with SMI is increasingly perceived as progress in terms of recovery. However, recovery is a complex and multidimensional concept defined in various ways (44-46). Three types of recovery In the typology used throughout this study, three types of recovery can be differentiated, evolving from the definition of recovery by Anthony. These types of recovery should not be considered mutually exclusive but rather as complementary aspects of recovery (47). The first type is clinical or symptomatic recovery (47-49), meaning the level of psychiatric symptoms at one point in time or the course of symptoms over time. Broadly defined, this also includes the number and duration of relapses (44, 48, 5052). The second type is functional recovery, defined as the degree of vocational and social functioning, such as acting age-appropriately, performing daily living tasks without supervision, engaging in social interactions (53), and independence with regard to housing (46, 50).

General introduction 13 The third type is personal recovery, a term that originated among people with lived experiences of mental illness and highlights the personal nature of the recovery process (54, 55). Sometimes called subjective recovery (56), it includes components such as spirituality, empowerment, actively accepting the illness, finding hope, reestablishing a positive identity, developing meaning in life, overcoming stigma, taking control of one’s own life, and having supporting relationships (48). In short, it concerns the extent of perceived recovery, sense of purpose, and personal agency (56). Various authors use the acronym CHIME to summarize the key elements of personal recovery: connectedness, hope, optimism about the future, identity, meaning in life, and empowerment (57). (2) Evidence-Based Practices Since the beginning of this century, the implementation of services shown to be effective in improving patient outcomes has become more important. Such services are referred to as Evidence-Based Practices (EBPs). An EBP is an intervention whose effectiveness in helping patients achieve positive outcomes has been supported by research. The highest scientific standard of research design is considered the randomized controlled trial (RCT). When multiple randomized controlled trials show that one intervention consistently outperforms others, there is support for calling that intervention an EBP (58). A consensus had emerged in the United States regarding several effective and efficient mental health interventions aimed at supporting people with SMI. These EBPs focused on symptom management, psychosocial functioning, and quality of life (59). However, research had shown that the vast majority of people with SMI did not receive evidence-based care because it was not part of routine mental health services (59). This was also demonstrated separately in people with schizophrenia (59-61). Six EBPs were selected for the National EBP Project In this context, a relevant US national demonstration project, the EBP Project, was developed and executed by the Center for Mental Health Services of the Substance Abuse and Mental Health Services Administration (SAMHSA) in collaboration with other national and local mental health authorities and several mental health research centers (59). This project aimed to develop standardized guidelines and training materials, presented as toolkits, and demonstrate how the toolkits could be used to promote faithful implementation of EBPs and improve outcomes for clients in routine mental health settings. The rationale for this EBP project was that it was not enough to know which interventions were supported by research evidence on outcomes but also to know about barriers and strategies regarding implementation (59).

Chapter 1 14 In 1998, six community-based EBPs for adults with SMI were selected in initial attempts to demonstrate implementation on a broader scale (58). This selection was conducted by a panel of mental health experts guided by a review of the literature. An implementation package was created for each EBP, and a large-scale study was conducted to examine the dissemination success. One of the selected EBPs was Illness Management and Recovery (IMR). IMR is discussed in detail in the following sections. The other five EBPs were (58): (1) Collaborative Psychopharmacology/Medication Management, which deals with systematic, shared medication decision-making that involves patients; (2) Assertive Community Treatment (ACT): a new case management approach, with a low caseload size, outreach care, direct provision of services by ACT practitioners, 24-hour coverage, and a shared caseload; (3) Family Psychoeducation: family intervention programs, usually lasting for at least 6 months, providing psychoeducation information and illness management, social support, and empathy to decrease stress; (4) Individual Placement and Support (IPS): a supported employment model supporting people with SMI to acquire competitive employment, aiming to support someone’s identity and self-esteem and to reduce self-stigma; and (5) Integrated Dual Disorders Treatment (IDDT), in which the same clinicians treat both mental health and substance abuse disorders simultaneously. Treatment includes case management, medication, housing, vocational rehabilitation, family interventions, and motivation-based interventions for addictive behaviors. The six EBPs of the US National EBPs Project have also been implemented to varying extents in the Netherlands. In this country, FACT, the Dutch version of ACT, has been most widely implemented (62). IMR has been implemented at several sites in various regions of the Netherlands (63-65). First, we will present some background information on illness self-management. What is illness (self) management? According to mental health practitioners, people with SMI were previously assumed to be unable to actively participate in directing their own treatment. Therefore, they depended on others to manage their psychiatric illnesses, meet their basic needs, and reach their personal goals. However, inspired by the psychiatric consumer self-advocacy movement (66-68) and the trend toward shared decisionmaking in medical treatment (69), mental health care has begun to engage consumers actively in determining their own outcomes. Illness self-management concerns individuals’ ability to care for themselves and regain control of their lives (70). This includes the ability to perform tasks needed to manage and live successfully with the physical, social, and emotional

General introduction 15 consequences of a serious and persistent condition (71, 72). More specifically, for people with SMI, it includes the ability to reduce their susceptibility to relapses and effectively cope with their symptoms. Having knowledge of mental illness to be able to make informed decisions about treatment together with professionals and the ability to reach out for social support are necessary for this (70, 73). Illness management is also referred to as illness self-management, self-care, or simply selfmanagement (71). Various illness management programs, including IMR, have been developed to support individuals with SMIs in improving the course of their illness (5, 56, 65, 71). These interventions aim to facilitate self-determination and well-being, develop fulfilling and valued workplace roles and social connections, and obtain housing (5, 56, 74-76). These programs include providing psychoeducation and teaching skills for informed decision-making on treatment, providing cognitive-behavioral training to support behavioral-tailored medication adherence, teaching social and coping skills to deal with symptoms or stress, learning to recognize early warning signs, developing a relapse prevention plan, and teaching improvement of social support (56, 71). Moreover, they should include a recovery-oriented component of learning to set and work toward personal goals (71). In clinical practice, illness (self) management programs are provided by both professionals and experts by experience. In a systematic review and meta-analysis, 37 trials on various self-management interventions in psychiatry including 5790 participants were evaluated (71). The criteria for inclusion in this study were providing psychoeducation, relapse prevention, coping skills training, medication management, and supporting progress on personal recovery goals. The proposed typology of the included studies was: 1. Illness management and compliance, 2. Bipolar-specific illness management, 3. Transition to the community from the ward, 4. Coping oriented, and 5. Recovery oriented (71). ‘’Illness management and compliance’’ included IMR; “Transition to community from ward” included different modules from Social & Independent Living Skills (SILS) (77-80), and “Recovery oriented” included WRAP (81), Building Recovery of Individual Dreams and Goals through Education and Support (BRIDGES) (82), and Recovery is Up to You (83). This meta-analysis found that self-management interventions provided benefits in terms of reduction in symptoms and duration of hospitalization and improvement in functioning and quality of life at both the end of treatment and at follow-up. Overall, effect sizes ranged from small to medium. Evidence for the effect of selfmanagement interventions on readmissions was mixed. However, self-

Chapter 1 16 management had a significant effect relative to control on subjective recovery measures, such as hope and empowerment at follow-up and self-rated recovery and self-efficacy at both time points (71). Although this review indicated the relevance of self-management interventions, it only included nine (24%) studies on IMR. The specific contribution of IMR to the various effects found is unknown. Therefore, additional IMR-specific experimental evidence was needed. What is Illness Management and Recovery (IMR)? IMR is a structured psychosocial program that aims to promote illness selfmanagement and recovery in individuals with schizophrenia and other SMIs (56). IMR aims to support consumers with SMI in acquiring the information and skills necessary to cooperate successfully with professionals and significant others in their treatment, to minimize the impact of mental illness on their lives, and to achieve meaningful personal goals. IMR includes a broad set of strategies designed to reduce susceptibility to illness and cope effectively with symptoms. The IMR program was developed based on a review of controlled research on teaching illness self-management strategies to clients with SMI (70). Five empirically supported strategies were identified in this review and incorporated into the program: (1) psychoeducation about mental illness and its treatment; (2) cognitive-behavioral approaches to medication adherence, assisting consumers who chose to use medications in integrating them into their everyday routines; (3) developing a relapse prevention plan; (4) strengthening social support through social skills training, using cognitive behavioral techniques such as reinforcement, modeling, role-play, and practicing skills in real-life situations; and (5) coping skills training for the management of persistent symptoms (56). To motivate clients to learn how to better manage their illness and help them move forward in their lives, IMR begins with an exploration of the meaning of recovery for the client and setting personal recovery goals to work toward in the program (56). The different parts of the IMR program were not new; the newness lay in offering them as an integrated package. The five empirically supported illness self-management strategies (70) are incorporated into the IMR program, which is organized into 11 curriculum topic areas. These topics are taught using a combination of educational, motivational, and cognitive-behavioral teaching strategies in weekly individual or group sessions that require approximately one year to complete. Homework assignments are developed collaboratively with the client. In addition, with clients’ consent, significant others (e.g., family and friends) are encouraged to be involved in helping

General introduction 17 clients learn self-management strategies and pursue their personal goals, which is a major part of IMR. Theoretical foundation of IMR The theoretical foundation of IMR relies on two models, the trans-theoretical and stress-vulnerability models (56, 84, 85). The trans-theoretical model holds that people are more motivated to acquire new behaviors if the types of intervention are adjusted to their current stage of change. This makes it easier for individuals to become aware of their problems, make decisions, and implement and sustain changes (86, 87). In line with the stress-vulnerability model, IMR trainers teach participants the basics of illness (self-) management, enabling them to reduce substance use, improve adherence to medication, increase coping and social support, and become involved in meaningful activities. This may improve illness outcomes such as symptoms, relapse, and hospitalization (short-term goals). Then, through the combination of pursuing personal goals and improving illness selfmanagement, the long-term goal of IMR is to help clients progress toward recovery, including objective (e.g., community functioning, social relationships, work) and subjective (e.g., sense of purpose, hope, confidence) recovery. The working mechanisms underlying IMR have been combined in a hypothetical conceptual framework, indicating that changes over time in illness selfmanagement skills are associated with changes in personal and functional recovery, mediated by changes in clinical recovery (56), see Chapters 3, 4 and 7, and Figure 1. Guidelines for IMR implementation are given in the IMR toolkit (88, 89), a guide to IMR implementation (90), several IMR implementation papers (58, 59, 91, 92), and three IMR fidelity scales: the IMR fidelity scale (93), IMR Treatment Integrity Scale (IT-IS) (94), and IMR General Organizational Index (GOI) (95). For the implementation of IMR in Bavo-Europoort Rotterdam in 2008-2009 (now merged into ANTES), an extensive implementation trajectory was followed after a visit to the United States (96) (see Chapters 2 and 5). This thorough initial implementation process included drafting an implementation plan; holding plenary meetings with all outpatient practitioners and members of the client council; forming a steering, implementation, and training committee; editing translated handouts and workbooks; holding a two-day training for trainers and supervisors; setting up supervision groups; starting six IMR groups; and launching a pilot study (97) (Chapter 2).

Chapter 1 18 FIGURE 1 Conceptual Framework for the Illness Management and Recovery program (56). IMR may be considered a complex and extended intervention. Consequently, providing IMR requires mastery of a variety of advanced clinical skills (98) (see Chapter 6). IMR is currently implemented in various countries, including the United States, the Netherlands, Denmark, Norway, Sweden, Spain, Japan, and Singapore (65). Variants of IMR This study used a translation of the American IMR curriculum, which was slightly adapted to the Dutch situation. The IMR program provides a program structure with room for individual interpretations. In some modules, for example, experts such as a psychiatrist in the medication module are invited, or a particular game or exercise that is not part of the formal IMR curriculum is performed. In the present study, on average, one module requires four meetings. However, the number of sessions per module may vary per group depending on the interests and needs of the participants. Over time, some variants of the IMR have emerged in the Netherlands. For some time, in the day treatment of former Bavo-Europoort, IMR was supplemented with several regular components of group treatment, so called “IMRplus”. Sometimes in the in-patient treatment facilities, only a few IMR modules are given, such as portions of "Practical Facts about Mental Illness", because the length of stay in the hospital is usually limited. Another variant of outpatient care is ‘’Strength’’ or FACT-plus (99). IMR program Goal setting Education about illness Using medications effectively Coping skills training Social skills training Relapse prevention training Alcohol and Drugs Use Coping Skills Meaningful Activities Social Support Program Proximal Outcomes Distal Outcomes Medications Stress Biological Vulnerability - Symptom control -Relapse Subjective recovery: - Perceived recovery - Sense of purpose - Personal agency - - - - - + + - Objective recovery: - Role funcioning - Social functioning

General introduction 19 More recently, another adaptation of the IMR workbooks was made, named "Eigen Regie en Herstel” (ERH) (Self-Direction and Recovery) (63). Finally, at ANTES (formerly Bavo-Europoort), a new version of the ERH curriculum was developed based on more than a decade of IMR experience and is now being used. The modernized ERH program includes 13 modules (100). Moreover, a version of IMR for people with mild intellectual disabilities ('IMR-light') was developed and was translated into Dutch (101, 102). The extent to which variants differ from the original version can be determined using a model fidelity assessment, if desired. The greater the difference, the more new research is required. Research on IMR In September 2018, we conducted a literature search that yielded 65 studies on IMR, including six randomized controlled trials (RCTs) (103-110). These six RCTs yielded inconsistent results. In short (we will return to this in the Discussion, Chapter 8), regarding illness selfmanagement as measured using the client version of the IMR scale (a scale that was also used as the primary outcome in the RCT executed as part of this thesis; see Chapter 5), three RCTs reported positive results for IMR compared with the control group (104, 105, 110), while the remaining three RCTs reported null results (103, 106, 107, 109). Regarding illness management, measured using the clinician version of the IMR scale, four RCTs reported positive results for IMR (103-105), whereas one RCT reported null results (107, 109). Three RCTs reported that IMR had positive effects on reducing psychiatric symptoms (104, 105, 110), whereas three RCTs identified in the literature search reported null results (104, 106, 108, 109). Regarding hospitalization, only one RCT reported positive results (110); the remaining RCTs reported no effect (103-106, 108). Three RCTs reported no effect on personal recovery (105-107, 109) and one RCT reported no effect on employment (104). Two RCTs did not observe any effects of IMR (106, 107, 108, 109). Because of these mixed results, more research was needed on the outcomes of IMR, particularly in the Dutch context. The differences in results between these studies may be related to variations in patient populations, sample sizes, control group characteristics, IMR duration, degree of IMR exposure, and model fidelity (65, 111).

Chapter 1 20 Impact of two implementation aspects: IMR fidelity and IMR completion Adequate dissemination and efficacy of research on EBPs for people with SMI require clear and precise specification of the quality of implementation (112-114). The relevance of fidelity lies in the assumption that “higher fidelity to an EBP predicts better outcomes for clients” (115). Fidelity is defined as the degree of adherence to the standards and principles of a program (112, 114). There are indications of this predictive validity of fidelity for some programs in the National EBPs Project in the United States (93), including ACT (116-120), IPS (121), and prior to our study (65) also for IMR (103, 122). Regarding the quality of implementation of IMR, not only fidelity, but also the level of exposure to IMR of participants (completion) appeared relevant to IMR efficacy (104, 106, 109). Completion refers to the level of IMR attendance (65) (Chapter 5). In addition to the percentage of participants exposed to >50% of the scheduled sessions, the total number of sessions attended appeared to be relevant. A minimum threshold of exposure to IMR may be required for treatment effects to occur (106). Before conducting the main study, we conducted a pilot study to explore the feasibility of a randomized controlled trial (97) (Chapter 2). This pilot study indicated that an RCT was feasible. However, the pilot study showed mixed results regarding the fidelity of the IMR implementation. The implementation of certain aspects of fidelity required further improvement. Moreover, the results indicated a 50% dropout rate from the treatment regimen (97). Based on the results of this pilot study and previous research, our main study explored the impact of fidelity and IMR completion rate on the efficacy of this intervention (Chapter 5). In the pilot study, the limitations of the IMR fidelity scale were revealed. Therefore, we added the IT-IS to the main study. Moreover, the study design was customized to facilitate completion analysis; a priori, we chose to assign more clients to the experimental condition (IMR) than the care as usual (CAU) group (76). In summary, although IMR appeared promising for implementation in the Netherlands, the inconsistent findings of previous studies indicated the need for further research on IMR efficacy and outcomes. The present study focused on two aspects of implementation that may have contributed to inconsistencies in the results of earlier RCTs: model fidelity and IMR completion.

General introduction 21 Research questions This study had four major aims: (1) to explore the effectiveness of IMR; (2) to explore the impact of IMR fidelity and the level of IMR exposure (completion) on IMR efficacy; (3) to comprehensively explore the implementation of the clinical skills of IMR practitioners; and (4) to explore the working mechanisms of IMR based on a conceptual framework. The remainder of this paragraph describes the research questions. The pilot study (Chapter 2) aimed to explore the feasibility of an RCT in the former Bavo-Europoort, a psychiatric institute in Rotterdam (now part of ANTES). To that end, our primary objective in the pilot study was to evaluate support for implementing IMR on a broader scale. Therefore, we examined participant recruitment, client outcomes, and client and clinician satisfaction. The secondary objectives were to evaluate fidelity, trainers’ training, and supervision, and to explore program duration, IMR dropout, and client characteristics related to dropout. Chapter 3 describes the study protocol for the RCT performed as part of this study (Chapter 5). In this multicenter, single-blind RCT, we aimed to compare the effects of IMR plus treatment as usual with treatment as usual alone for outpatients with SMI. We investigated whether IMR leads to better illness self-management, fewer symptoms, fewer relapses (clinical recovery), and better personal and functional recovery. The primary outcome measure was the client version of the IMR Scale, which measures overall illness (self-) management. Secondary outcome measures were the clinician’s version of the IMR scale, measures of illness (self-) management components, and measures of different types of recovery. We also investigated the impact of fidelity and completion on IMR efficacy. Measurements were taken before randomization and at 12 and 18 months after randomization. In Chapter 4, baseline data were used to cross-sectionally analyze the possible associations described in the IMR theoretical model (Figure 1). Our rationale lies in the interrelations among these concepts, as suggested by the IMR conceptual framework. The research questions were as follows: (1) are higher illness management component scores associated with higher clinical recovery scores, (2) are higher clinical recovery scores associated with higher functional and personal recovery scores, and alternatively, (3) are higher illness management scores associated with higher functional and personal recovery scores?

Chapter 1 22 The analyses described in Chapter 5 aimed to comprehensively investigate the effectiveness of IMR, including the impacts of completion and fidelity. Research questions were (1) whether IMR + CAU (IMR offered in group format) leads to better self-reported illness management (primary outcome) and to fewer symptoms and relapses (clinical recovery) than CAU alone, (2) whether IMR + CAU leads to better personal and functional recovery than CAU alone, (3) whether any improvement resulting from IMR + CAU is associated with the fidelity of IMR implementation, and (4) whether a higher IMR completion rate is associated with stronger effects (see above for Chapters 2 and 3). The analyses described in Chapter 6 evaluated whether IMR was implemented following the treatment model or program (model integrity). The objectives were to assess the fidelity and clinician competency in 15 IMR groups to establish the implementation level of all IMR elements and to explore the complementarity of the IT-IS with the standard IMR Fidelity Scale. The analyses described in Chapter 7 explored the working mechanisms of IMR, as described in the IMR conceptual framework, using longitudinal data. The research questions were as follows: what is the association between changes over time in illness self-management skills and changes in personal recovery, and to what degree is this association mediated by changes in clinical and functional recovery? Finally, Chapter 8 summarizes the major findings of this dissertation, followed by an elaboration and reflection on their strengths and limitations, future directions, clinical implications, and conclusions.

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