Family Connections vs Treatment at Usual Optimized in the treatment of relatives of people with eating disorders and personality disorders: Study protocol of a randomized control trial

Abstract

Abstract Background Family members of patients with eating disorders (ED) often experience high levels of burden, suffering, grief, and helplessness. If, in addition to ED, the patient has a personality disorder (PD), the psychological distress experienced by family members can be devastating. However, few treatments have been developed for family members of people with ED and PD. Family Connections (FC) is a program that has been shown to be effective in relatives of people with borderline personality disorder. The general objectives of this research project are: (a) to adapt and test the FC intervention protocol designed specifically for family members of patients with ED-PD in the Spanish population (FC: ED-PD); (b) to analyze, in a randomized controlled trial, the efficacy of the FC: ED-PD program versus a control condition consisting of optimized treatment as usual (TAU-O); (c) to analyze the feasibility and acceptability of the intervention protocol; (d) to analyze whether the changes that may occur in family members are related to improvements in the family climate and/or improvements observed in patients; and (e) to analyze the perceptions and opinions of families and patients about the two intervention protocols. Methods The study design consists of a two-arm randomized controlled trial with two conditions: FC: ED-PD or Treatment as usual optimized (TAU-O). Participants will be relatives of patients who meet DSM-5 criteria for ED and PD or dysfunctional personality traits. Participants will be assessed at pre- and post-treatment and one-year follow-up. The intention-to-treat principle will be used when analyzing the data. Discussion These results will also confirm the program’s efficacy and acceptance by family members. Trial registration ClinicalTrials.gov Identifier: NCT05404035. Accepted: May 2022.