Comparison between mum-baby interaction therapy and interpersonal therapy on women with postpartum depression: a multicentre, randomized, open and controlled clinical trial

Abstract

INTRODUCTION: Postpartum Depression (PPD) is a mental disorder defined as a set of feeling as sadness, guilt, inhibition, handicapped and loss of vital impulse that can appear during pregnancy or puerperia. It affects approximately 10-22% women, but it is an underdiagnosed and undertreated entity. PPD has negative consequences on women and on their children, as they have more risk of behavioural and emotional problems. During pregnancy and puerperia, women are frequently reluctant to take any drugs for depression. Psychotherapies for PPD have shown efficacy in reducing depressive symptoms, above all, the Interpersonal Therapy (IPT). However, it has the limitation that does not improve the link between women and their children, which is an important factor for the healthy development of children. The Mum-Baby Interaction Therapy (MBIT) has its central component on the mother and child relationship, but it does not have enough evidence of efficacy. HYPOTESIS: Women with PPD who completed the MBIT resulted in a non-inferiority outcome in the primary variable of Edinburgh Postnatal Depression Scale (EPDS) and in a better improvement of the mother-infant link evaluated with the Postpartum Bonding Questionnaire (PBQ), when compared to those who completed the IPT. OBJECTIVES: The main aim of this study is to assess the non-inferiority efficacy of the MBIT on women with PPD, in comparison with the IPT, measured with the principal variables of EPDS and PBQ. Secondary objectives are to assess if the following covariables are confounding factors: age, TPAL, unintended pregnancy, single mother, low socioeconomic status, antecedent of gender violence victim, antecedent of a depressive episode, antecedent of an eating disorder, substance abuse, body shape concern, sleeping disturbances and pharmacological treatment for PPD. METHODS: We will perform an open, controlled, randomized and multicentred clinical trial with two intervention groups: MBIT and IPT. Both interventions will be conducted by therapists specialized in each psychotherapy. They will last between 3 and 4 months