Relatives Clinical Trial
Official title:
Family Connections for Caregivers of People With Suicidal Behavior: Study Protocol of a Randomized Control Trial.
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05215392 -
A Smartphone Application of "Family Connections" to Relatives of People With Borderline Personality Disorder.
|
N/A | |
Completed |
NCT04037501 -
Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia
|
N/A | |
Recruiting |
NCT04160871 -
"Family Connections": a Program for Relatives of People With Borderline Personality Disorder
|
N/A | |
Completed |
NCT04638608 -
A Complex Intervention Study on a Palliative Rehabilitation Blended Learning Program to Support Relatives and Health Care Providers of People With ALS and Cognitive Impairments in Coping With Challenges
|
N/A | |
Recruiting |
NCT05404035 -
"Family Connections" for Caregivers of People With Eating Disorders and Personality Disorders.
|
N/A | |
Active, not recruiting |
NCT03460483 -
Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care
|
N/A | |
Recruiting |
NCT03296384 -
Influence of Environmental Factors and Schizophrenia
|
N/A | |
Completed |
NCT01060761 -
Involvement of Patients and Relatives in the Course of Cancer Disease
|
N/A | |
Completed |
NCT01213797 -
IMTAP : Impact of the Suicide Attempt on the Nearly Entourage in Term of Traumatic Stress and Medico-economic Impact
|
N/A | |
Not yet recruiting |
NCT06100978 -
Patient-reported Outcome and Patient-reported Experience After Status Epilepticus
|
||
Recruiting |
NCT06242301 -
Is a Collective Person-centered Dialogue Intervention for Hospitalised COPD Patients Feasible?
|
N/A | |
Completed |
NCT03264365 -
The Effectiveness of a Post-ICU Recovery Program on Relatives
|
N/A | |
Not yet recruiting |
NCT03271788 -
Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training
|
N/A | |
Completed |
NCT03635476 -
Survey of Lifelong Food and Nutrition Assistance (LIFANA) in Stroke Patients and Caregivers
|
||
Recruiting |
NCT03137420 -
Psychological Distress in Relatives of Severely Injured Patients
|