Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder: Study Protocol for a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015)
研究概览
简要总结
The main objective of this project is to adapt and evaluate the LIVE Skill module in the Spanish population. LIVE Skill is a psychological intervention protocol specifically designed to address identity disturbances in individuals with Borderline Personality Disorder (BPD). The project aims to examine its effectiveness in reducing identity disturbances, emotional regulation difficulties, and suicidal behavior, as well as in improving self-compassion, meaning in life, and personality functioning. In addition, the efficiency and feasibility of the program will be assessed by evaluating its acceptability among both patients and professionals, and its dissemination will be promoted to maximize its clinical impact.
The methodology includes a sample of approximately 112 individuals diagnosed with BPD, recruited through the Valencian Association for Personality Disorders (ASVA-TP), who will be allocated into two groups. The project is structured into five studies. First, a qualitative pilot feasibility study will be conducted with approximately 30 participants through focus groups and interviews in order to refine the intervention protocol. The second study will describe the randomized clinical trial protocol, including the interventions and assessment procedures. Subsequently, a randomized controlled trial (RCT) will be carried out, comparing LIVE Skill with treatment as usual (TAU), with assessments conducted at pre-treatment, post-treatment, and six-month follow-up. Following the trial, a qualitative evaluation will be undertaken to identify treatment facilitators and barriers. Finally, the psychometric validation of the questionnaires used in the study will be conducted.
The protocol will collect sociodemographic data and measures of identity, emotional regulation, self-compassion, meaning in life, suicidal ideation and behavior, personality functioning, as well as treatment acceptability and feasibility. Participants will provide informed consent and complete an initial assessment to confirm eligibility according to the inclusion and exclusion criteria.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 16 years old or more.
- •Having the diagnosis of Borderline Personality Disorder.
- •Currently receiving treatment or follow-up care at the recruitment center mentioned above.
- •Signing the informed consent form to participate in the study; in the case of minors, consent must be provided by parents or legal guardians.
排除标准
- •Individuals with severe conditions that may interfere with participation in the research-such as psychosis, schizophrenia, or intellectual disability.
- •Individuals with high substance use who are not in optimal condition to follow the treatment program.
- •Individuals who present an imminent risk of suicide or who are not in adequate psychological condition to participate in the program.
研究组 & 干预措施
TAU
Treatment as usual
干预措施: TAU (Behavioral)
结局指标
主要结局
Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015)
时间窗: baseline; immediately after the intervention; 6 months
It is a 27-item self-report instrument designed to evaluate identity consolidation and clinically significant identity disturbance. The SCIM items were created to assess key components of identity, as well as the presence or absence of disturbances in these areas. These components include: a) the continuity of self-concept and roles across different settings and interpersonal contexts, b) the consistency of personal values and interests, c) self-esteem, d) differentiation between oneself and others, and e) self-cohesion, understood as the feeling of being whole or complete. Participants were asked to rate the extent to which they agreed or disagreed with 27 statements. Responses were provided on a 7-point scale ranging from 1 to 7 (1 = strongly disagree, 2 = disagree, 3 = somewhat disagree, 4 = neither agree nor disagree, 5 = somewhat agree, 6 = agree, and 7 = strongly agree). Subscale scores were computed according to the direction of the construct being measured.
Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004); Spanish validation of Hervás & Jódar (2008).
时间窗: baseline; immediately after the intervention; 6 months
It adapted into Spanish by Hervás \& Jódar (2008), comprises 28 items that assess difficulties in several domains of emotion regulation, including emotional non-acceptance, emotional neglect, everyday interference, emotional confusion, and emotional dyscontrol. Responses are given on a 5-point Likert scale (1 = almost never; 5 = almost always), with higher scores indicating greater difficulties in emotion regulation. The Spanish version demonstrated high internal consistency .93 and acceptable psychometric properties, as well as convergent and incremental validity in both cross-sectional (N = 254) and longitudinal (N = 60) samples. This makes it a suitable and validated instrument for assessing difficulties in emotion regulation in Spanish-speaking adult populations.
次要结局
- Self-compassion Scale (SCS) (Neff, 2003); Spanish validation of García-Campayo et al. (2014).(baseline; immediately after the intervention; 6 months)
- Meaning in Life Questionnaire (MLQ) (Steger et al., 2006); Spanish validation of Marco et al. (2022).(baseline; immediately after the intervention; 6 months)
- Suicide Behaviors Questionnaire-Revised (SBQ-R) (Linehan, 1981); Spanish validation of García-Nieto et al. (2013).(baseline; immediately after the intervention; 6 months)
- Level of Personal Functioning Scale (LPFS) (Bender et al., 2011); Spanish validation of Schetsche, (2021).(baseline; immediately after the intervention; 6 months)
- Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) (Weiner et al., 2017).(baseline; immediately after the intervention; 6 months)
研究者
Isabel Fernández Felipe
Principal Investigator
Universidad Europea de Valencia