Place-Based FACT: Treatment Outcomes and Patients' Experience with Integrated Neighborhood-Based Care.

Locating specialized mental healthcare services in the neighborhood of people with severe mental illnesses (SMI) has been suggested as a way of improving treatment outcomes by increasing patient engagement and integration with the local care landscape. The current mixed methods study aimed to examine patient experience and treatment outcomes in three Flexible Assertive Community Treatment (FACT) teams that relocated to the neighborhood they served, compared to seven teams that continued to provide FACT as usual from a central office. Routine Outcome Measurement (ROM) and care use data were analyzed to compare change in treatment outcomes for patients in place-based FACT (n = 255) and FACT as usual (n = 833). Additionally, retrospective in-depth interviews were conducted with twenty patients about their experience with place-based FACT. Quantitative analysis showed mental health admission days decreased more in place-based than FACT as usual, although this difference was small. Both groups showed improved quality of life, psychosocial functioning, and symptomatic remission rates, and decreased unmet and overall needs for care. There was no change over time in met needs for care, employment, and daily activities. Qualitative analysis showed that patients experienced place-based FACT as more accessible, a better safety net, a more personal approach, better integrated with other forms of care, involving their social network, and embedded in their neighborhood and daily environment. This study showed that location and integration matter to patients, and the long term impact of place-based FACT on treatment outcomes should be explored.

Implementation and evaluation of a multi-level mental health promotion intervention for the workplace (MENTUPP): study protocol for a cluster randomised controlled trial.

BACKGROUND: Well-organised and managed workplaces can be a source of wellbeing. The construction, healthcare and information and communication technology sectors are characterised by work-related stressors (e.g. high workloads, tight deadlines) which are associated with poorer mental health and wellbeing. The MENTUPP intervention is a flexibly delivered, multi-level approach to supporting small- and medium-sized enterprises (SMEs) in creating mentally healthy workplaces. The online intervention is tailored to each sector and designed to support employees and leaders dealing with mental health difficulties (e.g. stress), clinical level anxiety and depression, and combatting mental health-related stigma. This paper presents the protocol for the cluster randomised controlled trial (cRCT) of the MENTUPP intervention in eight European countries and Australia. METHODS: Each intervention country will aim to recruit at least two SMEs in each of the three sectors. The design of the cRCT is based on the experiences of a pilot study and guided by a Theory of Change process that describes how the intervention is assumed to work. SMEs will be randomly assigned to the intervention or control conditions. The aim of the cRCT is to assess whether the MENTUPP intervention is effective in improving mental health and wellbeing (primary outcome) and reducing stigma, depression and suicidal behaviour (secondary outcome) in employees. The study will also involve a process and economic evaluation. CONCLUSIONS: At present, there is no known multi-level, tailored, flexible and accessible workplace-based intervention for the prevention of non-clinical and clinical symptoms of depression, anxiety and burnout, and the promotion of mental wellbeing. The results of this study will provide a comprehensive overview of the implementation and effectiveness of such an intervention in a variety of contexts, languages and cultures leading to the overall goal of delivering an evidence-based intervention for mental health in the workplace. TRIAL REGISTRATION: Please refer to Item 2a and registration ISRCTN14104664. Registered on 12th July 2022.

Adding physical activity to intensive trauma-focused treatment for post-traumatic stress disorder: results of a randomized controlled trial.

Introduction: This randomized controlled trial examined the effectiveness of physical activity added to an intensive trauma-focused treatment (TFT) for post-traumatic stress disorder (PTSD) in comparison to adding non-physical control activities. Methods: A total of 119 patients with PTSD were randomly assigned to a physical activity condition (PA; n = 59) or a non-physical activity control condition (nPA; n = 60). The 8-day intensive TFT programme consisted of daily prolonged exposure, EMDR therapy, and psychoeducation, which was complemented with physical activities versus controlled mixtures of guided (creative) tasks. As a primary outcome, the change in clinician and self-reported PTSD symptoms from pre-to post-treatment and at 6 months follow-up were measured. Results: Intent-to-treat linear mixed-effects models showed no significant differences between the PA and nPA conditions on change in PTSD severity. Clinician and self-reported PTSD symptoms significantly decreased for both conditions, with large effect sizes (e.g., CAPS-5 dpre-post = 2.28). At post-treatment, 80.0% in the PA, and 82.7% in the nPA condition no longer met the diagnostic criteria for PTSD. Regarding the loss of Complex PTSD diagnoses this was 92.5% and 95.0%, respectively. Conclusion: Either with additional physical or non-physical activities, intensive TFT is very effective for the treatment of (Complex) PTSD, as reflected by large effect sizes and loss of diagnostic status in both groups. Clinical trial registration: Trialregister.nl Identifier: Trial NL9120.

Outcome assessment of a complex mental health intervention in the workplace. Results from the MENTUPP pilot study.

OBJECTIVE: Multicomponent interventions are recommendable to achieve the greatest mental health benefits, but are difficult to evaluate due to their complexity. Defining long-term outcomes, arising from a Theory of Change (ToC) and testing them in a pilot phase, is a useful approach to plan a comprehensive and meaningful evaluation later on. This article reports on the pilot results of an outcome evaluation of a complex mental health intervention and examines whether appropriate evaluation measures and indicators have been selected ahead of a clustered randomised control trial (cRCT). METHODS: The MENTUPP pilot is an evidence-based intervention for Small and Medium Enterprises (SMEs) active in three work sectors and nine countries. Based on our ToC, we selected the MENTUPP long-term outcomes, which are reported in this article, are measured with seven validated scales assessing mental wellbeing, burnout, depression, anxiety, stigma towards depression and anxiety, absenteeism and presenteeism. The pilot MENTUPP intervention assessment took place at baseline and at 6 months follow-up. RESULTS: In total, 25 SMEs were recruited in the MENTUPP pilot and 346 participants completed the validated scales at baseline and 96 at follow-up. Three long-term outcomes significantly improved at follow-up (p < 0.05): mental wellbeing, symptoms of anxiety, and personal stigmatising attitudes towards depression and anxiety. CONCLUSIONS: The results of this outcome evaluation suggest that MENTUPP has the potential to strengthen employees' wellbeing and decrease anxiety symptoms and stigmatising attitudes. Additionally, this study demonstrates the utility of conducting pilot workplace interventions to assess whether appropriate measures and indicators have been selected. Based on the results, the intervention and the evaluation strategy have been optimised.

Evidence for the effectiveness of interventions to reduce mental health related stigma in the workplace: a systematic review.

OBJECTIVES: Increasing access to mental health support is a key factor for treating mental disorders, however, important barriers complicate help-seeking, among them, mental health related stigma being most prominent. We aimed to systematically review the current evidence for interventions focusing on reducing stigma related to mental health problems in small and medium enterprises (SMEs). DESIGN: Systematic review with a focus on interventions targeting mental health related stigma in the workplace in accordance with PRISMA guidelines. The methodological quality of included articles was assessed using the Quality Assessment Tool for Quantitative Studies Scale. DATA SOURCES: PubMed, Ovid Medline, PsycINFO, Scopus, and Cochrane databases and Google Scholar were searched from January 2010 until November 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included experimental or quasi-experimental studies about workplace interventions aiming to reduce stigma, where the outcomes were measured in terms of stigmatisation against depression, anxiety and/or other mental health problems. DATA EXTRACTION AND SYNTHESIS: Records were screened by two independent reviewers after inspecting titles and abstracts and a full-text read of the articles to assess whether they meet inclusion criteria. The results were synthesised narratively. RESULTS: We identified 22 intervention studies, 3 with high quality, 13 with moderate quality and 6 with weak quality. Only 2 studies included SMEs, but no study focused on SMEs exclusively . The mode of delivery of the intervention was face to face in 15 studies, online in 4 studies and mixed in 3 studies. We found a significant reduction in stigmatising attitudes in almost all studies (20/22), using 10 different instruments/scales. Effects seemed to be independent of company size. Online interventions were found to be shorter, but seemed to be as effective as face-to-face interventions. CONCLUSIONS: Although we did not find interventions focusing exclusively on SMEs, it is likely that antistigma interventions also will work in smaller workplaces. TRIAL REGISTRATION: PROSPERO: ID: CRD42020191307.

Supporting employees with mental illness and reducing mental illness-related stigma in the workplace: an expert survey.

An expert survey was designed to support the development of a workplace-based multi-country intervention tackling depression, anxiety, and mental illness-related stigma in small- and medium-sized enterprises (SMEs). Academic experts and representatives of SME organisations, specific sector organisations, labour or advocacy groups, and occupational health organisations, were contacted across eight European countries and Australia. The survey comprised closed and open text questions to assess expert opinion about interventions for employees with mental health difficulties, interventions supporting their managers, and anti-stigma interventions. The survey was available in six languages. The online platform Qualtrics was used for data collection. Quantitative data was analysed through descriptive statistics and qualitative data was analysed through thematic analysis. Sixty-five of 146 experts responded, representing a 42% response rate. Results showed only 26.2% of experts agreed that employees could speak openly about mental health issues, and 81.5% of experts indicated a large or medium unmet need for support for employees with mental health issues. Psychoeducational materials, face-to-face workshops and interventions based on cognitive behavioural therapy were ranked most likely to be taken up by employees. Experts rated as most useful for managers' guidelines on how to act if an employee has mental health issues (67.7%). The greatest number of experts indicated workshops of people with lived experience of mental illness (80.0%) and awareness campaigns (78.5%) were most required to tackle stigma. Responses were consistent between experts from different countries and areas of expertise. Experts in this multinational survey assessed that interventions supporting mental health in the workplace and tackling stigma are greatly needed. A multicomponent intervention with a wide range of materials and tools is supported.

Feasibility and outcomes of narrative enhancement and cognitive therapy (NECT) for reducing self-stigma among people with severe mental illness in the Netherlands: A pilot study.

OBJECTIVE: The narrative enhancement and cognitive therapy (NECT) intervention aims to reduce self-stigma among people with severe mental illness. Based on previous studies that showed the intervention's beneficial outcomes, we conducted an uncontrolled pilot study of NECT in the Netherlands to assess both feasibility in delivering NECT and outcomes of the intervention for self-stigma, hope, recovery, and self-concept clarity. METHODS: Feasibility was assessed through uptake and implementation data that included an assessment of enhancing and impeding factors according to surveys with NECT facilitators, and interviews with participants. Outcomes of NECT were studied through scales that assess self-stigma, self-concept clarity, hope, personal recovery, and quality of life. RESULTS: Forty-one participants from five treatment sites participated in the pilot study, among whom 78% were considered "exposed" (i.e., attended at least six sessions). The analysis of enhancing and impeding factors indicated that support from the organization, sense of ownership, expectations of outcomes, and content of the intervention were reported as important in the implementation process. Participants reported decreases in self-stigma and increases in hope during the intervention. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Assessments of feasibility provided valuable insights regarding ways to improve implementation of the intervention (such as increasing facilitators' sense of ownership of the intervention). Outcomes of NECT showed a decrease in self-stigma and improvement of hope among participants in this pilot study, supporting the previously found positive effects of the intervention. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Who benefits from individual placement and support? A meta-analysis.

AIMS: Individual placement and support (IPS) is an evidence-based service model to support people with mental disorders in obtaining and sustaining competitive employment. IPS is increasingly offered to a broad variety of service users. In this meta-analysis we analysed the relative effectiveness of IPS for different subgroups of service users both based on the diagnosis and defined by a range of clinical, functional and personal characteristics. METHODS: We included randomised controlled trials that evaluated IPS for service users diagnosed with any mental disorder. We examined effect sizes for the between-group differences at follow-up for three outcome measures (employment rate, job duration and wages), controlling for methodological confounders (type of control group, follow-up duration and geographic region). Using sensitivity analyses of subgroup differences, we analysed moderating effects of the following diagnostic, clinical, functional and personal characteristics: severe mental illness (SMI), common mental disorders (CMD), schizophrenia spectrum disorders, mood disorders, duration of illness, the severity of symptoms, level of functioning, age, comorbid alcohol and substance use, education level and employment history. RESULTS: IPS is effective in improving employment outcomes compared to the control group in all subgroups, regardless of any methodological confounder. However, IPS was relatively more effective for service users with SMIs, schizophrenia spectrum disorders and a low symptom severity. Although IPS was still effective for people with CMD and with major depressive disorder, it was relatively less effective for these subgroups. IPS was equally effective after both a short and a long follow-up period. However, we found small, but clinically not meaningful, differences in effectiveness of IPS between active and passive control groups. Finally, IPS was relatively less effective in European studies compared to non-European studies, which could be explained by a potential benefits trap in high welfare countries. CONCLUSIONS: IPS is effective for all different subgroups, regardless of diagnostic, clinical, functional and personal characteristics. However, there might be a risk of false-positive subgroup outcomes and results should be handled with caution. Future research should focus on whether, and if so, how the IPS model should be adapted to better meet the vocational needs of people with CMD and higher symptom severity.

Cost Effectiveness and Budget Impact of the Boston University Approach to Psychiatric Rehabilitation for Increasing the Social Participation of Individuals With Severe Mental Illnesses.

Background: The purpose of this study was to investigate the cost-effectiveness and budget impact of the Boston University Approach to Psychiatric Rehabilitation (BPR) compared to an active control condition (ACC) to increase the social participation (in competitive employment, unpaid work, education, and meaningful daily activities) of individuals with severe mental illnesses (SMIs). ACC can be described as treatment as usual but with an active component, namely the explicit assignment of providing support with rehabilitation goals in the area of social participation. Method: In a randomized clinical trial with 188 individuals with SMIs, BPR (n = 98) was compared to ACC (n = 90). Costs were assessed with the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P). Outcome measures for the cost-effectiveness analysis were incremental cost per Quality Adjusted Life Year (QALY) and incremental cost per proportional change in social participation. Budget Impact was investigated using four implementation scenarios and two costing variants. Results: Total costs per participant at 12-month follow-up were € 12,886 in BPR and € 12,012 in ACC, a non-significant difference. There were no differences with regard to social participation or QALYs. Therefore, BPR was not cost-effective compared to ACC. Types of expenditure with the highest costs were in order of magnitude: supported and sheltered housing, inpatient care, outpatient care, and organized activities. Estimated budget impact of wide BPR implementation ranged from cost savings to €190 million, depending on assumptions regarding uptake. There were no differences between the two costing variants meaning that from a health insurer perspective, there would be no additional costs if BPR was implemented on a wider scale in mental health care institutions. Conclusions: This was the first study to investigate BPR cost-effectiveness and budget impact. The results showed that BPR was not cost-effective compared to ACC. When interpreting the results, one must keep in mind that the cost-effectiveness of BPR was investigated in the area of social participation, while BPR was designed to offer support in all rehabilitation areas. Therefore, more studies are needed before definite conclusions can be drawn on the cost-effectiveness of the method as a whole.

Effectiveness of the Boston University Approach to Psychiatric Rehabilitation in Improving Social Participation in People With Severe Mental Illnesses: A Randomized Controlled Trial.

BACKGROUND: People with severe mental illnesses (SMIs) have difficulty participating in society through work or other daily activities. AIMS: To establish the effectiveness with which the Boston University Approach to Psychiatric Rehabilitation (BPR) improves the level of social participation in people with SMIs, in the Netherlands. METHOD: In a randomized controlled trial involving 188 people with SMIs, we compared BPR (n = 98) with an Active Control Condition (ACC, n = 90) (Trial registration ISRCTN88987322). Multilevel modeling was used to study intervention effects over two six-month periods. The primary outcome measure was level of social participation, expressed as having participated in paid or unpaid employment over the past six months, as the total hours spent in paid or unpaid employment, and as the current level of social participation. Secondary outcome measures were clients' views on rehabilitation goal attainment, Quality of Life (QOL), personal recovery, self-efficacy, and psychosocial functioning. RESULTS: During the study, social participation, QOL, and psychosocial functioning improved in patients in both groups. However, BPR was not more effective than ACC on any of the outcomes. Better social participation was predicted by previous work experience and a lower intensity of psychiatric symptoms. CONCLUSIONS: While ACC was as effective as BPR in improving the social participation of individuals with SMIs, much higher percentages of participants in our sample found (paid) work or other meaningful activities than in observational studies without specific support for social participation. This suggests that focused rehabilitation efforts are beneficial, irrespective of the specific methodology used.

Improvements in cardiorespiratory fitness are not significantly associated with post-traumatic stress disorder symptom reduction in intensive treatment.

Background: Physical activity has been found to have positive effects on symptoms of post-traumatic stress disorder (PTSD). However, the importance and role of cardiorespiratory fitness (CRF) in relation to PTSD treatment outcome is not yet clear. Objective: The purpose of the present study was to test the hypothesis that CRF would increase following intensive trauma-focused treatment (TFT) of PTSD augmented with physical activity, and that improved CRF would be associated with a significant decline in PTSD symptoms. Method: One hundred-eight individuals with severe PTSD (72% women; mean age = 40.44, SD = 11.55) were enrolled in an intensive TFT programme of 8 days within 2 consecutive weeks that consisted of daily prolonged exposure (PE), eye movement desensitization and reprocessing (EMDR) therapy and 6 hours of physical activity each day. CRF levels were assessed at baseline and post-treatment with a 6-Minute Walk Test (6MWT) and, in a subsample, with a submaximal ergometer test (PWC75%/kg). Severity of PTSD symptoms was measured with the PTSD Symptom Scale-Self Report (PSS-SR). Results: A significant increase in CRF from pre- to post-treatment and a significant decrease of PTSD-symptoms was found. However, CRF difference scores were not associated with treatment outcome. Conclusions: Although individuals with PTSD may show an increase in CRF following an intensive TFT programme augmented with physical activity and a decrease of PTSD-symptoms, the current findings do not support the notion that treatment outcome is related to CRF.

Antecedentes: Se ha encontrado que la actividad física tiene efectos positivos sobre los síntomas del trastorno de estrés postraumático (TEPT). Sin embargo, la importancia y el papel de la actividad física cardiorrespiratoria (cardiorespiratory fitness, CFR) en relación con el resultado del tratamiento del TEPT aún no está claro.Objetivo: El propósito del presente estudio fue probar la hipótesis de que la CFR mejoraría después del tratamiento intensivo de TEPT centrado-en-el-trauma (TFT) potenciado con actividad física, y que la CFR optimizado se asociaría con una disminución significativa de los síntomas del TEPT.Método: Ciento ocho individuos con TEPT severo (72% mujeres; edad media = 40.44, DE = 11.55) se inscribieron en un programa intensivo de TFT de 8 días dentro de 2 semanas consecutivas que consistió en exposición diaria prolongada (PE), Terapia de Desensibilización y Reprocesamiento por Movimientos Oculares (EMDR) y 6 horas de actividad física cada día. Los niveles de CRF se evaluaron al inicio y después del tratamiento con una prueba de caminata de 6 minutos (6MWT) y, en una submuestra, con una prueba de ergómetro submáxima (PWC75%/kg). La gravedad de los síntomas de TEPT se midió con el Informe de Escala de Síntomas del TEPT (PSS-SR). Resultados: Se encontró un aumento significativo en la CFR desde antes y hasta después del tratamiento y una disminución significativa de los síntomas de TEPT. Sin embargo, las puntuaciones de diferencia de CRF no se asociaron con el resultado del tratamiento.Conclusiones: Aunque las personas con TEPT pueden mostrar un aumento en el CFR después de un programa intensivo de TFT potenciado con actividad física y una disminución de los síntomas de TEPT, los hallazgos actuales no respaldan la noción de que el resultado del tratamiento está relacionado con la CFR.

Identifying social participation subgroups of individuals with severe mental illnesses: a latent class analysis.

PURPOSE: To investigate factors that influence participation in and needs for work and other daytime activities among individuals with severe mental illnesses (SMI). METHODS: A latent class analysis using routine outcome monitoring data from 1069 patients was conducted to investigate whether subgroups of individuals with SMI can be distinguished based on participation in work or other daytime activities, needs for care in these areas, and the differences between these subgroups. RESULTS: Four subgroups could be distinguished: (1) an inactive group without daytime activities or paid employment and many needs for care in these areas; (2) a moderately active group with some daytime activities, no paid employment, and few needs for care; (3) an active group with more daytime activities, no paid employment, and mainly met needs for care; and (4) a group engaged in paid employment without needs for care in this area. Groups differed significantly from each other in age, duration in MHC, living situation, educational level, having a life partner or not, needs for care regarding social contacts, quality of life, psychosocial functioning, and psychiatric symptoms. Differences were not found for clinical diagnosis or gender. CONCLUSIONS: Among individuals with SMI, different subgroups can be distinguished based on employment situation, daytime activities, and needs for care in these areas. Subgroups differ from each other on patient characteristics and each subgroup poses specific challenges, underlining the need for tailored rehabilitation interventions. Special attention is needed for individuals who are involuntarily inactive, with severe psychiatric symptoms and problems in psychosocial functioning.

The Role of Working Alliance in Attainment of Personal Goals and Improvement in Quality of Life During Psychiatric Rehabilitation.

OBJECTIVE: A key aspect of psychiatric rehabilitation is supporting individuals with serious mental illness in reaching personal goals. This study aimed to investigate whether various aspects of the working alliance predict successful goal attainment and whether goal attainment improves subjective quality of life, independent of the rehabilitation approach used. METHODS: Secondary analyses were conducted of data from a Dutch randomized clinical trial on goal attainment by individuals supported with the Boston University approach to psychiatric rehabilitation (N=80) or a generic approach (N=76). Working alliance was measured with the Working Alliance Inventory (WAI) from the practitioner's perspective. Rehabilitation practitioners had backgrounds in social work, nursing, or vocational rehabilitation. Multiple logistic regression and multiple regression analyses explored effects of working alliance on goal attainment and of goal attainment on subjective quality of life at 24 months. Analyses were controlled for client- and process-related predictors, baseline quality of life, and rehabilitation approach. RESULTS: The WAI goal subscale predicted goal attainment at 24 months. No effect was found for the bond or task subscale. Goal attainment significantly predicted quality of life at 24 months. These effects were independent of the rehabilitation approach used. CONCLUSIONS: A good bond between client and practitioner is not enough to attain successful rehabilitation outcomes. Findings suggest that it is important to discuss clients' wishes and ambitions and form an agreement on goals. Attaining rehabilitation goals directly influenced the subjective quality of life of individuals with serious mental illness, which underscores the importance of investing in these forms of client support.

FiRe: Evaluation of a fidelity measure to promote implementation of evidence-based rehabilitation.

OBJECTIVE: This article describes a measure developed to assess fidelity of working with the Boston University approach to Psychiatric Rehabilitation (BPR) in Dutch mental health care. The instrument is intended to measure and improve BPR adherence and clinician competence on an individual level and within individual rehabilitation processes. METHOD: Rotating pairs of 4 BPR specialists used Fidelity of Rehabilitation (FiRe) to evaluate the fidelity of BPR as applied in 114 rehabilitation processes. The content of these processes was documented by the 27 rehabilitation practitioners who delivered the approach. RESULTS: Interrater reliability (.66) was good as were correlations between the first and second assessments (.74), also increasing over time. FiRe was able to distinguish those delivering the approach at an expert level from nonexperts, expressing concurrent validity. FiRe was also related to practitioner attitude toward rehabilitation, a possibly similar construct. In this study, the average level of BPR adherence according to our fidelity model was low. During the 10.5-month review period, overall FiRe scores improved slightly, but this effect was not significant. However, practitioners reported that feedback based on FiRe helped them to enhance their skills. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: This first version of FiRe is a valid and reliable instrument with which to gain insight into the quality and fidelity of individual practitioners' rehabilitation practices. The instrument used in this study will be further developed in line with study results. More importantly, FiRe raises questions about the definition of good BPR, a topic that should be explored more extensively in future research. (PsycINFO Database Record

Cost effectiveness and budgetary impact of the Boston University approach to Psychiatric Rehabilitation for societal participation in people with severe mental illness: a randomised controlled trial protocol.

BACKGROUND: People with Severe Mental Illness (SMI) frequently experience problems with regard to societal participation (i.e. work, education and daily activities outside the home), and require professional support in this area. The Boston University approach to Psychiatric Rehabilitation (BPR) is a comprehensive methodology that can offer this type of support. To date, several Randomised Controlled Trials (RCT's) investigating the effectiveness of BPR have yielded positive outcomes with regard to societal participation. However, information about the cost-effectiveness and budgetary impact of the methodology, which may be important for broader dissemination of the approach, is lacking. BPR may be more cost effective than Care As Usual (CAU) because an increase in participation and independence may reduce the costs to society. Therefore, the aim of this study is to investigate, from a societal perspective, the cost-effectiveness of BPR for people with SMI who wish to increase their societal participation. In addition, the budget impact of implementing BPR in the Dutch healthcare setting will be assessed by means of a budget impact analysis (BIA) after completion of the trial. METHODS: In a multisite RCT, 225 adults (18-64 years of age) with SMI will be randomly allocated to the experimental (BPR) or the control condition (CAU). Additionally, a pilot study will be conducted with a group of 25 patients with severe and enduring eating disorders. All participants will be offered support aimed at personal rehabilitation goals, and will be monitored over a period of a year. Outcomes will be measured at baseline, and at 6 and 12 months after enrolment. Based on trial results, further analyses will be performed to assess cost-effectiveness and the budgetary impact of implementation scenarios. DISCUSSION: The trial results will provide insight into the cost-effectiveness of BPR in supporting people with SMI who would like to increase their level of societal participation. These results can be used to make decisions about further implementation of the method. Also, assessing budgetary impact will facilitate policymaking. The large sample size, geographic coverage and heterogeneity of the study group will ensure reliable generalisation of the study results. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN88987322. Registered 13 May 2014.

Physical, social and societal functioning of children with congenital adrenal hyperplasia (CAH) and their parents, in a Dutch population.

BACKGROUND: Most research concerning congenital adrenal hyperplasia (CAH) and related conditions caused by primary adrenal insufficiency, such as Addison's or Cushing's disease, has focused on medical aspects rather than on patients' quality of life. Therefore, our objective was to investigate the physical, social and societal functioning of children with CAH and their parents in a Dutch population. METHODS: The study is descriptive and cross-sectional. Self-designed questionnaires, based on questionnaires developed in the Netherlands for different patient groups, were sent to parents of children with CAH between 0 and 18 years old. Participants were recruited through the Dutch patient group for Adrenal Disease (NVACP) and six hospitals in the Netherlands. Three different questionnaires were designed for parents: for children aged 0 - 4, aged 4 - 12 and aged 12 - 18. Additionally, a fourth questionnaire was sent to adolescents with CAH aged 12 - 18. Main outcome measures were experienced burden of the condition, self-management and participation in several areas, such as school and leisure time. RESULTS: A total of 106 parents returned the questionnaire, 12 regarding pre-school children (0-4 years), 63 regarding primary school children (4-12 years), and 32 regarding secondary school children (12-18 years), combined response rate 69.7%. Also, 24 adolescents returned the questionnaire. Children and adolescents with CAH appear to be capable of self-management at a young age. Experienced burden of the condition is low, although children experience several health related problems on a daily basis. Children participate well in school and leisure time. Few children carry a crisis card or emergency injection with them. CONCLUSIONS: Overall, our research shows that, according to their parents, children with CAH experience few negative effects of the condition and that they participate well in several areas such as school and leisure time. However, improvements can be made concerning the measures parents and children must take to prevent an adrenal crisis.