No-Restraint Committed General Hospital Psychiatric Units (SPDCs) in Italy-A Descriptive Organizational Study.

This study describes and explores the application of no-restraint policies in General Hospital Psychiatric Units (GHPUs) in Italy, a country pioneering in deinstitutionalization and psychiatric reform. The research aims to assess the organizational characteristics and effectiveness of no-restraint practices, contributing to the global discourse on humane psychiatric care. Following a purposive sampling approach, a nationwide descriptive study was conducted involving a detailed online survey distributed to 24 GHPUs actively engaged in or aspiring toward no-restraint practices. The survey, comprising 60 items across seven sections, gathered comprehensive data on the structural, organizational, and operational dimensions of the units, along with the prevalence and management of restraint episodes. Results reveal a significant commitment to no-restraint policies, with 14 GHPUs reporting zero restraint incidents in 2022. Despite variations in infrastructure and staffing, a common thread was the implementation of systematic procedures and risk management training aimed at reducing coercive practices. The study identified a correlation between the use of exclusive garden spaces and an increased incidence of restraints, suggesting nuanced factors influencing restraint practices. The findings underscore the viability and ethical alignment of no-restraint practices within psychiatric care, highlighting the crucial role of organizational protocols and training. This research adds empirical weight to the advocacy for restraint-free environments in mental health settings, signaling a paradigm shift toward more humane and rights-respecting psychiatric care.

Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: results and lessons of an underpowered randomised clinical trial.

BACKGROUND: As lithium treatment might be effective in reducing the risk of deliberate self-harm (DSH) in adult patients with unipolar affective disorders, we designed a pragmatic randomised trial to assess its efficacy in more than 200 patients with treatment-resistant depression. However, we randomised 56 patients only. The aim of this report is therefore twofold: first, to disseminate the results of this underpowered study which may be incorporated into future meta-analytical reviews; second, to analyse some critical aspects of the study which might explain failure to reach the target sample size. METHODS: We carried out a randomised, parallel group, assessor-blinded superiority clinical trial. Adults with a diagnosis of major depression, an episode of DSH in the previous 12 months and inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode were allocated to add lithium to usual care (intervention arm) versus usual care alone (control arm). Suicide completion and acts of DSH during the 12 months of follow-up constituted the composite primary outcome. RESULTS: Of 58 patients screened for inclusion, 29 were allocated to lithium plus usual care and 27 were assigned to usual care without lithium. Six patients in the lithium plus usual care group and seven in the usual care group committed acts of DSH during the follow-up phase. The survival probability did not differ between the two treatment arms (Chi2 = 0.17, p =0.676). With regard to changes in the severity of depressive symptomatology from baseline to endpoint, no significant differences were detected. CONCLUSIONS: The present study failed to achieve the minimum sample size needed to detect a clinically meaningful difference between the two treatment arms. Consequently, the finding that lithium, in addition to usual care, did not exert a positive effect in terms of reduction of DSH after 12 months of follow-up is likely due to the lack of sufficient statistical power to detect a difference, if a difference existed. The dissemination of the results of this underpowered study will inform future meta-analytical reviews on lithium and suicide-related outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00927550.

Involvement of users and relatives in mental health service evaluation.

Although Italian mental health (MH) services are community based, user and relative participation in service evaluation lagged behind until lately. We here review three recent studies involving stakeholder participation in service evaluation: two were quantitative studies, one on 204 users in an MH service in Pistoia (Central Italy) and the other on 2259 relatives, conducted with the National Union of Associations for Mental Health. The third (supported by The Centro per il Controllo delle Malattie, the ministerial Center for Disease Control) was a qualitative study in seven MH services, involving users, relatives, and professionals together, which collected interviews from 136 users, 119 relatives, and 79 professionals. In the quantitative studies, positive evaluations outnumbered negative ones. The qualitative study explored negative aspects in greater depth. Common findings were insufficient information, underinvolvement of users-relatives in planning, no choice of clinician, psychiatrist domination, and limited helpfulness of interventions. With stakeholder participation in service evaluation, the present medical framework will need reshaping.

Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: a protocol for a randomised, independent, pragmatic, multicentre, parallel-group, superiority clinical trial.

BACKGROUND: Data on therapeutic interventions following deliberate self harm (DSH) in patients with treatment-resistant depression (TRD) are very scant and there is no unanimous consensus on the best pharmacological option for these patients. There is some evidence that lithium treatment might be effective in reducing the risk of completed suicide in adult patients with unipolar affective disorders, however no clear cut results have been found so far. The primary aim of the present study is to assess whether adding lithium to standard therapy is an effective treatment strategy to reduce the risk of suicidal behaviour in long term treatment of people with TRD and previous history of DSH. METHODS/DESIGN: We will carry out a randomised, parallel group, assessor-blinded superiority clinical trial. Adults with a diagnosis of major depression, an episode of DSH in the previous 12 months and inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode will be allocated to add lithium to current therapy (intervention arm) or not (control arm). Following randomisation, treatment is to be taken daily for 1 year unless some clear reason to stop develops. Suicide completion and acts of DSH during the 12 months of follow-up will constitute the composite primary outcome. To preserve outcome assessor blindness, an independent adjudicating committee, blind to treatment allocation, will anonymously review all outcome events. DISCUSSION: The results of this study should indicate whether lithium treatment is associated with lower risk of completed suicide and DSH in adult patients with treatment resistant unipolar depression, who recently attempted suicide. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00927550.