NCT05157607

Family Connections for Caregivers of People With Suicidal Behavior

Family Connections for Caregivers of People With Suicidal Behavior: Study Protocol of a Randomized Control Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The aim of our study is to verify the efficacy of the Family Connections intervention for relatives of people diagnosed with suicidal behavior disorder in a randomized control trial with a Spanish participants.

Detailed description

Family members of people who have attempted suicide feel guilty, afraid, hopeless, depression and anxiety. The needs of family members of people with suicide attempts are not adequately addressed in the current treatments for people with suicide attempts. Therefore, it is necessary to help the relatives of people with suicidal behaviors to reduce the discomfort and burden they experience by giving them information and skills to improve their relationship with patients. Family Connections (FC) is a program that has been shown to be effective in reducing burden, depression, and anxiety, and in increasing dominance and validating behaviors in relatives of people with borderline personality disorder. However, there are no Randomized Control Trials that demonstrate the efficacy of FC program in patients with suicide attempts. In a previous study, FC was adapted in an open trial with relatives of people who had attempted suicide. The results of this pilot study suggest that the FC program tailored to relatives of patients with suicide attempts may be effective in improving well-being and reducing the burden of illness in relatives. Our research team adapted FC for relatives of people diagnosed with suicidal behavior disorder (SBD) for delivery in the Spanish population. The FC-SCD program contains 12 two-hour sessions held once a week. The first aim is to verify the efficacy of the FC intervention for relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample of participants from mental health services. 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. The study design consists of a two-arm randomized controlled trial, there will be two conditions: Family Connections (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 INQ, PHQ-9, OASIS, VIRS, LUMP. Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing data, using mixed-effects models with full information and maximum likelihood estimation.

Conditions

• Relatives

Interventions

Type	Name	Description
BEHAVIORAL	Family Connections Protocol for Relatives of Patients with SBD.	Family Connections is a Dialectical Behavioral Therapy. All the modules include practice exercises, video viewing, and homework assignments. In addition, throughout the program, with the aim of increasing social support, the FC-SBD program provides a forum where participants can stay in touch and share common problems and solutions.
BEHAVIORAL	Treatment as Usual Optimized Protocol (TAU-O)	Participants will receive the usual treatment in their mental health service and will also receive a psychoeducation session of approximately 3 hours where the predictive and protective factors of suicidal behavior will be explained.

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2021-12-15
• Last updated: 2022-12-06

Locations

1 site across 1 country: Spain