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Background Despite several guidelines recommend the use of psychoeducational family interventions (PFIs) as add-on in the treatment of patients with bipolar I disorder, their implementation on a large scale remains limited. The aim of the present study is to identify obstacles for the feasibility of PFIs in routine care. Methods This was a multicentre, real-world, controlled, outpatient trial, carried out in 11 randomly recruited Italian mental health centres. Two mental health professionals from each center attended a modular training course on PFI and provided the intervention. Difficulties and benefits experienced by mental health professionals in implementing the intervention were assessed through the Family Intervention Schedule (FIS-R), which was administered six times. Results Sixteen out of the 22 recruited professionals completed the training and administered the PFI to 70 patients with bipolar I disorder and their relatives. The retention rate of families receiving the intervention was 93%. Mental health professionals reported high levels of organizational difficulties, several benefits in their daily clinical work and low levels of intervention-related difficulties. The most important organizational obstacles were related to the need to integrate the intervention with other work responsibilities and to the lack of time to carry out the intervention. These difficulties did not decrease over time. Intervention-related difficulties were rated as less problematic since the first time assessment and tended to improve over time. Limitations Low number of recruited professionals; use of a not previously validated assessment instrument. Conclusions PFIs are feasible in routine care for the treatment of patients with bipolar I disorder and their relatives, and main obstacles are related to the organization/structure of mental health centres, and not to the characteristics of the intervention itself.

Gaia Sampogna,1 Mario Luciano,1 Valeria Del Vecchio,1 Claudio Malangone,1,2 Corrado De Rosa,1 Vincenzo Giallonardo,1 Giuseppina Borriello,1 Benedetta Pocai,1 Micaela Savorani,1 Luca Steardo Jr,1 Debora Lampis,3 Franco Veltro,4 Francesco Bartoli,5 Francesco Bardicchia,6 Anna Maria Moroni,7 Giusy Ciampini,8 Emanuele Orlandi,9 Silvia Ferrari,10 Silvia Biondi,11 Sonia Iapichino,11,12 Enrico Pompili,13 Massimiliano Piselli,14 Alfonso Tortorella,15 Giuseppe Carrà,5,16 Andrea Fiorillo1 1Department of Psychiatry, University of Campania “Luigi Vanvitelli”, Naples, 2Mental Health Centre of Ravello, Mental Health Unit, Ravello, 3Mental Health Centre of Lanusei, Mental Health Unit, Lanusei, 4Mental Health Department of Campobasso, Campobasso, 5Department of Medicine and Surgery, University of Milano Bicocca, Monza, 6Mental Health Centre of Grosseto, Mental Health Unit, Grosseto, 7Niguarda Hospital, Department of Psychiatry, Milan, 8Mental Health Centre of Lanciano, Mental Health Unit, Lanciano, 9Mental Health Centre of Sassuolo, Mental Health Unit, Sassuolo, 10University of Modena and Reggio Emilia, Department of Psychiatry, Reggio Emilia, 11Mental Health Centre of Montecatini, Mental Health Unit, Montecatini, 12Auditor Psychiatrist, for the activities of Clinical Risk Management and safety of treatments, Tuscany Region, 13Mental Health Centre of Rome, Mental Health Unit, Rome, 14Mental Health Centre of Foligno, Mental Health Unit, Foligno, 15Department of Medicine, Section of Psychiatry, University of Perugia, Perugia, Italy; 16Division of Psychiatry, University College of London, London, UK Background: Psychoeducational family intervention (PFI) has been proven to be effective in improving the levels of family burden and patients’ personal functioning in schizophrenia and bipolar disorders (BDs). Less is known about the impact of PFI on relatives’ coping strategies in BD. Methods: A multicenter, controlled, outpatient trial funded by the Italian Ministry of Health and coordinated by the Department of Psychiatry of the University of Campania “Luigi Vanvitelli” has been conducted in patients with bipolar I disorder (BD-I) and their key relatives consecutively recruited in 11 randomly selected Italian community mental health centers. We aim to test the hypothesis that PFI improves problem-oriented coping strategies in relatives of BD-I patients compared to the Treatment As Usual (TAU) group. Results: The final sample was constituted of 123 patients and 139 relatives. At baseline assessment (T0), the vast majority of relatives already adopted problem-oriented coping strategies more frequently than the emotion-focused ones. At the end of the intervention, relatives receiving PFI reported a higher endorsement of adaptive coping strategies, such as “maintenance of social interests” (odds ratio [OR]=0.309, CI=0.04–0.57;p=0.023), “positive communication with the patient” (OR=0.295, CI=0.13–0.46;p=0.001), and “searching for information” (OR=0.443, CI=0.12–0.76;p=0.007), compared to TAU relatives, after controlling for several confounders. As regards the emotion-focused coping strategies, relatives receiving the experimental intervention less frequently reported to adopt “resignation” (OR=-0.380, CI=-0.68 to -0.08; p=0.014) and “coercion” (OR=-0.268, CI=-0.46 to -0.08;p=0.006) strategies, compared to TAU relatives. Conclusion: PFI is effective in improving the adaptive coping strategies of relatives of BD-I patients, but further studies are needed for evaluating the long-term benefits of this intervention. Keywords: coping strategies, family burden, psychoeducation family intervention, bipolar disorder, social functioning

Background This study assessed the efficacy of the Falloon model of psychoeducational family intervention (PFI), originally developed for schizophrenia management and adapted to bipolar I disorder. The efficacy of the intervention was evaluated in terms of improvement of patients׳ social functioning and reduction of family burden. Methods This was a multicentre, real-world, controlled, outpatient trial carried out in 11 randomly recruited Italian mental health centres. Enroled patients and key-relatives were consecutively allocated either to receive PFI and Treatment As Usual (TAU) or to a waiting list receiving TAU alone. The efficacy of the intervention was evaluated in terms of improvement in patients׳ social functioning (primary outcome) and reduction of family burden (secondary outcome). Results Of the 137 recruited families, 70 were allocated to the experimental group and 67 to the control group. At the end of the intervention, significant improvements in patients׳ social functioning and in relatives׳ burden were found in the treated group compared to TAU. This effect of the intervention remained also after controlling for several confounding patient׳s socio-demographic and clinical factors. The experimental intervention had an impact also on other outcome measures, such as patients׳ clinical status and personal burden. Limitations Lack of an active control group. Conclusions The results of this study clearly show that the psychoeducational family intervention according to the Falloon model is effective in improving the social outcome of patients with bipolar I disorder.