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.

The development and psychometric evaluation of the Questionnaire Epistemic Trust (QET): A self-report assessment of epistemic trust.

Epistemic trust (ET) refers to the predisposition to trust information as authentic, trustworthy and relevant to the self. Epistemic distrust - resulting from early adversity - may interfere with openness to social learning within the therapeutic encounter, reducing the ability to benefit from treatment. The self-report Questionnaire Epistemic Trust (QET) is a newly developed instrument that aims to assess ET. This study presents the first results on the psychometric properties of the QET in both a community and a clinical sample. Our findings indicate that the QET is composed of four meaningful subscales with good to excellent internal consistency. The QET shows relevant associations with related constructs like personality functioning, symptom distress and quality of life. QET scores clearly distinguish between a clinical and community sample and are associated with the quality of the therapeutic alliance. The QET provides a promising, brief and user-friendly instrument that could be used for a range of clinical and research purposes. Future studies with larger samples are needed to strengthen construct validity and to investigate the value of the QET to predict differential treatment responses or to study mechanisms of change.

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.

Study protocol of a randomized, double-blind, placebo-controlled, multi-center trial to treat antipsychotic-induced weight gain: the Metformin-Lifestyle in antipsychotic users (MELIA) trial.

BACKGROUND: Antipsychotic-induced Weight Gain (AiWG) is a debilitating and common adverse effect of antipsychotics. AiWG negatively impacts life expectancy, quality of life, treatment adherence, likelihood of developing type-2 diabetes and readmission. Treatment of AiWG is currently challenging, and there is no consensus on the optimal management strategy. In this study, we aim to evaluate the use of metformin for the treatment of AiWG by comparing metformin with placebo in those receiving treatment as usual, which includes a lifestyle intervention. METHODS: In this randomized, double-blind, multicenter, placebo-controlled, pragmatic trial with a follow-up of 52 weeks, we aim to include 256 overweight participants (Body Mass Index (BMI) > 25 kg/m2) of at least 16 years of age. Patients are eligible if they have been diagnosed with schizophrenia spectrum disorder and if they have been using an antipsychotic for at least three months. Participants will be randomized with a 1:1 allocation to placebo or metformin, and will be treated for a total of 26 weeks. Metformin will be started at 500 mg b.i.d. and escalated to 1000 mg b.i.d. 2 weeks thereafter (up to a maximum of 2000 mg daily). In addition, all participants will undergo a lifestyle intervention as part of the usual treatment consisting of a combination of an exercise program and dietary consultations. The primary outcome measure is difference in body weight as a continuous trait between the two arms from treatment inception until 26 weeks of treatment, compared to baseline. Secondary outcome measures include: 1) Any element of metabolic syndrome (MetS); 2) Response, defined as ≥5% body weight loss at 26 weeks relative to treatment inception; 3) Quality of life; 4) General mental and physical health; and 5) Cost-effectiveness. Finally, we aim to assess whether genetic liability to BMI and MetS may help estimate the amount of weight reduction following initiation of metformin treatment. DISCUSSION: The pragmatic design of the current trial allows for a comparison of the efficacy and safety of metformin in combination with a lifestyle intervention in the treatment of AiWG, facilitating the development of guidelines on the interventions for this major health problem. TRIAL REGISTRATION: This trial was registered in the Netherlands Trial Register (NTR) at  https://www.trialregister.nl/trial/8440 as NTR NL8840 on March 8, 2020.

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.

Symptomatic and Functional Remission in Young Adults with a Psychotic Disorder in a Rehabilitation Focused Team.

The aim of this study is to assess symptomatic remission (SR) and functional remission (FR) in a rehabilitation focused program for young adults with a psychotic disorder in the Netherlands, and to investigate which individual and mental health care factors are associated with SR and/or FR, by using Routine Outcome Monitoring data and data on met needs and unmet needs for care. Data of 287 young adults were collected. Almost 40% achieved or maintained SR, 34% FR, and 26% achieved or maintained both. In addition to sociodemographic factors, living independently, paid employment, higher levels of compliance with treatment, and better fulfillment of unmet needs for care in relation to psychological distress, company and daytime activities were associated with better outcomes on SR and/or FR. Our findings underscore that to successfully improve and sustain remission in young adults with a psychotic disorder, it is needed to conduct specific research into the relationship between SR and FR.

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.