The Efficacy of Psychoeducational Family Intervention for Individuals With Major Depression: a Randomized Controlled Trial

The present paper is a no-profit, not-funded, national, multicentric, randomized-controlled trial with blinded outcome assessments, carried out in 24 Italian University outpatient units and coordinated by the Department of Mental and Physical Health and Preventive Medicine of the University of Campania Luigi Vanvitelli. In each center, 8 patients (and their families) and 8 controls will be recruited, for a total of 192 families assigned to the experimental group and 192 to the control group (total sample size = 384 families). Families are assessed at the baseline and 6-, 12- and 24-months post-randomization.

The primary aim of this study is to assess the efficacy of PFI in a group of patients with a diagnosis of MDD in terms of: 1) reduction of depressive symptoms; 2) improvement of psychosocial functioning; 3) improvement of social network. Furthermore, the efficacy of PFI will be also evaluated in terms of: 1) reduction of relapses and hospitalization in the 18 months following the end of the intervention; 2) improvement of adherence to pharmacological treatments and of patients' quality of life; 3) reduction of self-stigma; 4) improvement of coping strategies, family burden, and expressed emotion of family members of patients with major depression; 5) improvement of quality of life of family members. Finally, our study will investigate whether the presence of specific temperamental profiles and childhood traumas may mediate the effectiveness of the psychoeducational intervention.

The experimental intervention consists of the psychoeducational family intervention developed by Ian Falloon for the treatment of schizophrenia, which has been adapted to major depression and to the Italian context. The experimental intervention will be administered individually to each recruited family and consists of six phases: 1) engagement of the family unit; 2) individual assessment; 3) family assessment; 4) informative sessions; 5) communication skills sessions; 6) problem-solving skills sessions.

Patients and their relatives will be provided with information on: 1) the clinical characteristics of MDD, including onset and course, symptoms, prognosis, risk and protective factors; 2) available pharmacological and non-pharmacological treatments of MDD, its indications, side effects and strategies to cope with them, treatment duration, risk factors for relapse, and effects related to abrupt cessation of the therapy; 3) early signs of crisis, with the identification of the user's specific signs, completion and use of an ad-hoc form, the usefulness of their recognition for the prevention of episodes. A specific informative session on suicide has been developed, which will be administered only if the patients had a previous suicide attempt or report suicidal ideation during the intervention.

Each meeting is ideally divided into three phases: a first phase dedicated to clarifications and questions regarding the topics previously discussed; a second phase focused on the main topic of the meeting (the so-called "teaching phase"); and a final phase, in which the salient aspects discussed during the meeting are summarized, and "homework" is assigned.