Abstract Background: Approximately one-third of all patients with schizophrenia are treatment resistant. Worldwide, undertreatment with clozapine and other effective treatment options exist for people with treatment-resistant schizophrenia (TRS). In this respect, it appears that regular health care models do not optimally fit this patient group. The Collaborative Care (CC) model has proven to be effective for patients with severe mental illness, both in primary care and in specialized mental health care facilities. The key principles of the CC model are that both patients and informal caregivers are part of the treatment team, that a structured treatment plan is put in place with planned evaluations by the team, and that the treatment approach is multidisciplinary in nature and uses evidence-based interventions. We developed a tailored CC program for patients with TRS. Objective: In this paper, we provide an overview of the research design for a potential study that seeks to gain insight into both the process of implementation and the preliminary effects of the CC program for patients with TRS. Moreover, we aim to gain insight into the experiences of professionals, patients, and informal caregivers with the program. Methods: This study will be underpinned by a multiple case study design (N=20) that uses a mixed methods approach. These case studies will focus on an Early Psychosis Intervention Team and 2 Flexible Assertive Community treatment teams in the Netherlands. Data will be collected from patient records as well as through questionnaires, individual interviews, and focus groups. Patient recruitment commenced from October 2020. Results: Recruitment of participants commenced from October 2020, with the aim of enrolling 20 patients over 2 years. Data collection will be completed by the end of 2023, and the results will be published once all data are available for reporting. Conclusions: The research design, framed within the process of developing and testing innovative interventions, is discussed in line with the aims of the study. The limitations in clinical practice and specific consequences of this study are explained.
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Abstract 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 16years 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 2000mg 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.
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Background: There is still limited evidence on the effectiveness and implementation of smoking cessation interventions for people with severe mental illness (SMI) in Dutch outpatient psychiatric settings. The present study aimed to establish expert consensus on the core components and strategies to optimise practical implementation of a smoking cessation intervention for people treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands. Design: A modified Delphi method was applied to reach consensus on three core components (behavioural counselling, pharmacological treatment and peer support) of the intervention. The Delphi panel comprised five experts with different professional backgrounds. We proposed a first intervention concept. The panel critically examined the evolving concept in three iterative rounds of 90 min each. Responses were recorded, transcribed verbatim and thematically analysed. Results: Overall, results yielded that behavioural counselling should focus on preparation for smoking cessation, guidance, relapse prevention and normalisation. Pharmacological treatment consisting of nicotine replacement therapy (NRT), Varenicline or Bupropion, under supervision of a psychiatrist, was recommended. The panel agreed on integrating peer support as a regular part of the intervention, thus fostering emotional and practical support among patients. Treatment of a co-morbid cannabis use disorder needs to be integrated into the intervention if indicated. Regarding implementation, staff’s motivation to support smoking cessation was considered essential. For each ambulatory team, two mental health care professionals will have a central role in delivering the intervention. Conclusions: This study provides insight into expert consensus on the core components of a smoking cessation intervention for people with SMI. The results of this study were used for the development of a comprehensive smoking cessation program.
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