Family connections vs treatment at usual optimized in the treatment of relatives of people with suicidal behavior disorder: study protocol of a randomized control trial

Background Relatives of people diagnosed with suicidal behavior disorder (SBD) feel guilty, afraid, hopeless, depression and anxiety. It is necessary to help the relatives of people with SBD to reduce their discomfort and burden. Family Connections (FC) is a program that has been shown to be effective in reducing burden, depression, and anxiety, and increasing dominance and validating behaviors in relatives of people with borderline personality disorder. However, there are no RCTs that demonstrate the efficacy of the FC program in patients with SBD. Our research team adapted FC for relatives of people with SBD for delivery in the Spanish population (FC-SBD). The FC-SBD program contains 12 two-hour sessions held once a week. The first aim is to verify the efficacy of the FC-SBD intervention for relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample. The second objective is to analyze the feasibility and acceptance of FC-SBD in relatives. The third aim is to analyze whether the changes produced in the psychological variables in the relatives after the intervention are related to changes in the psychological variables of the patients. This paper presents the study protocol. Methods The study design consists of a two-arm randomized controlled trial with two conditions: FC-SBD or Treatment as usual optimized (TAU-O). Participants will be relatives of patients who meet DSM-5 criteria for SBD. The caregivers` primary outcome measures will be the BAS. Secondary outcomes will be DASS-21, FES, DERS, QoL. The patient’s primary outcome measures will be the frequency of critical incidents with the family member with SBD. Secondary measures will be the INQ, PHQ-9, OASIS. Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing the data. Discussion This study will provide results that confirm the efficacy of the FC-SBD in relatives of people with SBD. These results will also confirm its good acceptance by family members and help us to find out whether it is a good program to improve the prevention of suicidal behaviors in the family environment. Trial registration ClinicalTrials.gov ID: NCT05157607 . Registered 15 December 2021.