Efficacy of "Family Connections", a Program for Relatives of People With Borderline Personality Disorder in Spanish Population: A Study Protocol for a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Burden Assessment Scale (BAS; Reinhard & Horwitz, 1992).
研究概览
简要总结
The aim of this study is to validate an intervention for relatives of people with borderline personality disorder in Spanish population in a randomized control trial.
详细描述
Family members of patients with borderline personality disorder (BPD) often experience high levels of suffering, anxiety, stress, burden and helplessness. The treatment program with the most empirical support is "Family Connections". It is one of the first programs specifically designed to help relatives of patients with BPD. The program is an adaptation of multiple strategies of Dialectical Behavioral Therapy. It consists of 12 sessions with an approximate duration of two hours each. The results of these studies and their subsequent replications showed an improvement in family attitudes and perceived burden. The investigators have translated and adapted the program so that it could be applied to the Spanish population. The aim of the present study is to evaluate the effectiveness of the adaptation of "Family connections" in Spanish population through a controlled clinical trial. The first hypothesis of the study is that "Family Connections" will be more effective (significant reduction in the primary outcome variables), compared with a Treatment As Usual (TAU), in the posttest time and in the follow-ups of 3 and 6 months. In addition, a second hypothesis is that "Family Connections" will be more efficient (fewer abandonments, better opinion on the part of the patients) than TAU.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older.
- •Having a relative with DSM-5 diagnosis of Personality Disorder
- •Understand spoken and written Spanish.
- •Grant informed consent.
排除标准
- •Diagnosis of severe mental disorder.
- •Presence of medical illness that may interfere with psychological treatment.
- •Suicide risk.
结局指标
主要结局
Burden Assessment Scale (BAS; Reinhard & Horwitz, 1992).
时间窗: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
Burden Assessment Scale (BAS) consists of 19 items and it assess the caregivers' objective and subjective burden within the past six months. Items are rated on a 4-point Likert scale ranging from 1(nothing) to 4 (a lot), and higher values indicate stronger burden. Internal reliability of the scale ranged from .89 to .91 and it shows adequated validity (Reinhard, Gubman, Horwitz \& Minsky, 1994).
Family Assessment Device - Global Functioning Scale (FAD-GFS; Epstein, Baldwin & Bishop, 1983).
时间窗: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.
Family Assessment Device - Global Functioning Scale (FAD-GFS) is a self-report questionnaire (Epstein, Baldwin \& Bishop, 1983). It consists of 60 items about family functioning. It is composed of seven subscales: Problem-Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, Behavior Control and General Functioning. Items are rated on a 4-point Likert scale ranging from 1 (totally agree) to 4 (totally disagree), and higher scores indicate unhealthy functioning. Cronbach's alphas ranges from .72 to .83 for the subscales and general functioning is .92 (Miller, Epstein, Bishop \& Keitner, 1985) and test-retest for the FAD scales were adequate (Miller, Epstein, Bishop \& Keitner, 1985).
次要结局
- Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.)
- Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; Hervás & Jódar, 2008).(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.)
- Family Empowerment Scale (FES; Koren, DeChillo & Friesen, 1992).(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.)
- Structured Clinical Interview for DSM-IV Axis II (SCID-II; First, Gibbon, Spitzer, Williams & Benjamin, 1997).(Pre-treatment)
- Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003).(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; Mezzich, Cohen, Ruipérez & Yoon, 1999).(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.)
- Beck Hopelessness Scale (BHS; Beck, Weissman, Lester & Trexler, 1974).(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.)
- Personality Inventory for DSM-5 (PID-5; Krueger, Derringer, Markon, Watson & Skodol, 2012).(Pre-treatment)
- Openness To the Future Scale (OFS; Botella et al., 2018).(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.)