Efficacy of psychoeducational family intervention for bipolar I disorder: A controlled, multicentric, real-world study

Abstract

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.

Introduction

There is a consistent body of evidence that pharmacological treatment alone may not be sufficient to control symptoms and maintain psychosocial functioning of patients with bipolar I disorder (Geddes and Miklowitz, 2013, Prasko et al., 2013, Leclerc et al., 2013). Several psychosocial interventions have been proposed to supplement pharmacotherapy in order to improve the outcome of people suffering from this disorder (Miklowitz and Otto (2007)). Among different approaches (Torrent et al., 2013), psychoeducation has shown the most promising results, in particular by increasing patients׳ knowledge about the disorder (Stafford and Colom, 2013), improving depressive symptoms (Miller et al., 2008, Parikh et al., 2012) but also patients׳ adherence to treatment (Clarkin et al., 1998, Lyman et al., 2014), and reducing relapses and hospitalizations (Miklowitz et al., 2003, Colom et al., 2009), in particular in patients at the onset of the disorder (Reinares et al., 2010, Reinares et al., 2008). Moreover, the review by Rouget and Aubry (2007) had concluded that psychoeducation should become part of routine mental health care for people with bipolar I disorder, as also suggested by some international guidelines (Goodwin, 2009, National Institute for Health and Care Excellence, 2013). On the other hand, a systematic review carried out by the Cochrane Collaboration (Justo et al., 2007) concluded that there was a poor and mixed amount of evidence supporting the effectiveness of family oriented approaches for bipolar disorders, making impossible to draw firm conclusions about their role as additional treatment for these disorders. The results of the systematic review were confirmed by de Barros Pellegrinelli et al. (2013) who reported that psychoeducation is ineffective in preventing mood episodes or improving functioning in bipolar patients. This apparent inconsistency is probably due to the fact that several different approaches are included under the label of “psychoeducation” (Lucksted et al., 2012), with several changes over the years (Colom, 2014, Fiorillo et al., 2013a). These approaches differ as regards: a) the composition of group participants (e.g., single or multiple families, involvement or not of the ill relative, etc.); b) the setting where sessions are provided (e.g., hospital, outpatient unit, family home); c) treatment duration; d) role and expertise of professionals running the intervention; e) information provided (Dixon et al., 2011, McFarlane, 2002, Leff, 2000, Fadden, 1998, Miklowitz and Goldstein, 1997, Solomon et al., 1996).

Psychoeducation has proved to be more effective when relatives are included in the treatment programme. In fact, the family may play a significant role in bipolar disorder, similar to schizophrenia (National Mental Health Project Working Group, 2006a, Magliano et al., 2006b) and major depression (Luciano et al., 2012a), in which living in a dysfunctional family is associated with more frequent relapses and hospitalizations, lack of compliance, and a worse social functioning (Carrà et al., 2012, Fiorillo et al., 2013a, Viana et al., 2013). Moreover, in bipolar disorders, high levels of family burden can have a detrimental effect not only on patients׳ long-term outcome, but also on caregivers׳ quality of life and well-being (Ogilvie et al., 2005, Steele et al., 2010, Pompili et al., 2014). In particular, relatives of patients with bipolar disorders often report family financial difficulties, impairment in marital and parenting role, and restriction in social and leisure activities (Heru and Ryan, 2002, the STEP-BD Family Experience Collaborative Study Group, 2007, Ganguly et al., 2010, Beentjes et al., 2012).

To our knowledge, no study has evaluated the impact of PFI on social and family outcome of patients with bipolar I disorder treated in ordinary mental health care settings. In fact, the vast majority of available PFI trials have been carried out in tertiary settings, adopting strict selection criteria and methodologies (Miklowitz and Scott, 2009, Fiorillo et al., 2013a).

The study presented herein, funded by the Italian Ministry of Health and coordinated by the Department of Psychiatry of the University of Naples SUN, has been carried out in 11 Italian community mental health centres, with the aim to assess the efficacy of the Falloon psychoeducational intervention (1985) adapted to bipolar I disorder as add-on therapy to Treatment As Usual (TAU) compared to TAU alone.

The primary outcome of the study was the improvement in patients׳ social functioning, assessed in terms of reduction in global score on the Disability Assessment Scale (DAS). The secondary study outcome was the reduction of family burden, assessed by the objective and subjective burden subscales of the Family Problem Questionnaire (FPQ).