Family Connections for Caregivers of People With Suicidal Behavior: Study Protocol of a Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Burden assessment scale (BAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being a caregiver of one patient with a diagnosis of Suicide Behavior Disorder
- •Understand spoken and written Spanish;
- •Signing the informed consent.
排除标准
- •The presence of a diagnosis of severe mental disorder in the caregivers as: Psychosis, schizophrenia, substance dependence, or high suicide ideation.
研究组 & 干预措施
Family Connections Protocol for Relatives of Patients with SBD.
The intervention lasts three months and includes 12 sessions with a weekly two-hour group format. The FC program is divided into six modules:
Module 1: Up-to-date information and research on suicide (Epidemiology, frequency, Risk factors, protective factors).
Module 2: Psychoeducation on the development of suicide, explanatory theories, available treatments, comorbidity.
Module 3: Emotional regulation skills, skills of acceptance, validation, approach, awareness, and to decrease emotional reactivity.
Module 4: Skills to improve the quality of relationships in family interactions (letting go of guilt and anger, acceptance skills in relationships).
Module 5: Communication skills and effective self-expression. Module 6: Problem management and making safe plans for crisis management.
干预措施: Family Connections Protocol for Relatives of Patients with SBD. (Behavioral)
Treatment as Usual Optimized Protocol (TAU-O).
Family members in this condition will continue to receive their treatment as usual in their care center of reference. In addition, we will optimize the treatment based on the recommendations of the international guidelines for the treatment of suicide. There will be one three-hour session in group format with the following component:
Module 1: Updated information and research on suicide (Epidemiology, frequency, Risk factors, protective factors). Psychoeducation on the development of Suicide, Explanatory theories. Available treatments, and comorbidity.
干预措施: Treatment as Usual Optimized Protocol (TAU-O) (Behavioral)
结局指标
主要结局
Burden assessment scale (BAS)
时间窗: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
This 19-item scale assesses two dimensions of caregiver burden of a loved one's illness (objective and subjective) in the past six months. The items are rated on a 4-point Likert scale (1-4), where higher scores indicate higher levels of illness burden. The psychometric properties of this scale are adequate, with an internal reliability between .89 and .91 and adequate validity.
次要结局
- Family empowerment scale (FES)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- Depression, anxiety, and stress scale (DASS-21)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- Difficulties in emotion regulation scale - Spanish version(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- Quality of life index-Spanish version (QLI-Sp)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- Opinion and Expectations of Treatment Scale (OTSM)(Changes will be assessed from pre-treatment to immediately after the intervention)
- Register of critical incidents with the family member with SBD(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
研究者
Jose H. Marco
Associate Professor of Psychology
University of Valencia