Valencia
Valencia, 46010, Spain
NCT Number: NCT07684872
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.
Trial opening soon.
Get Notified16 year and older
All sexes
Interventional
Not applicable
Valencia, 46010, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Identity disturbance skills based on DBT
Treatment as usual
Time frame: 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.
Time frame: 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.
Time frame: baseline; immediately after the intervention; 6 months
Adapted into Spanish by García-Campayo et al. (2014), comprises 26 items (long form) designed to assess self-compassion across six components: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Items are rated on a 5-point Likert scale (1 = almost never; 5 = almost always), with higher values indicating greater self-compassion. The Spanish version demonstrated good internal consistency .87 and adequate psychometric properties, including test-retest reliability and construct validity, supporting its use in Spanish-speaking populations. The authors also validated a short form (12 items, SCS-SF), which showed .85 for the total score and acceptable subscale reliability, as well as stability over time and strong correlation with the full version.
Time frame: baseline; immediately after the intervention; 6 months
In its Spanish version by Marco et al. (2022), measures two core dimensions of meaning in life: presence of meaning and search for meaning. The MLQ is composed of 10 items (five per dimension), rated on a 7-point Likert scale (1 = false; 7 = true), with higher scores indicating greater presence or search of meaning. In the Spanish adaptation, two-factor structure (Presence / Search) was confirmed via confirmatory factor analysis, with good internal consistency (Presence .86; Search .87). Test-retest reliability (one-month interval) was moderate (≈ .70 for Presence; ≈ .73 for Search), and the Spanish MLQ showed adequate convergent validity with measures of purpose, well-being, anxiety, and depression. Therefore, the Spanish MLQ is a valid and reliable instrument for assessing meaning in life in adult Spanish samples.
Time frame: baseline; immediately after the intervention; 6 months
It's a brief self-report instrument consisting of 4 items, designed to assess past and current suicidal thoughts and behaviors, as well as the likelihood of future suicide. In the Spanish adaptation, administered to a sample of 325 undergraduates, the SBQ-R showed good internal consistency .81 and temporal stability (test-retest ICC = .88). A confirmatory factor analysis supported the construct's validity of the scale, and criterion-related validity was demonstrated via correlations with other psychological measures. Thus, the Spanish SBQ-R appears to be a reliable and valid tool for identifying individuals - especially among young adults - at elevated risk of suicidal behavior.
Time frame: baseline; immediately after the intervention; 6 months
It was translated and adapted into Spanish by Schetsche (2021). The Spanish LPFS-BF 2.0 retains the conceptual structure of the original, assessing personality functioning along two correlated domains: self-functioning and interpersonal functioning, and allowing for a general functioning score. In the adaptation study (N = 361), confirmatory factor analysis supported a bifactorial structure (self-vs. interpersonal functioning plus a general factor), internal consistency was found to be acceptable, and convergent validity was demonstrated through significant correlations with personality trait measures. Therefore, the Spanish LPFS-BF 2.0 constitutes a valid and reliable instrument for assessing personality functioning in Spanish-speaking populations.
Time frame: baseline; immediately after the intervention; 6 months
It's a brief (4-item) self-report instrument designed to assess key implementation outcomes: perceived acceptability, appropriateness, and feasibility of an intervention or implementation strategy. Each item is rated on a 5-point Likert scale ranging from 1 = "completely disagree" to 5 = "completely agree," and higher scores indicate greater perceived acceptability, appropriateness, or feasibility. Psychometric evaluation demonstrated good internal consistency (α between .85 and .91 in the 4-item forms), structural validity (three-factor confirmatory factor analysis with acceptable fit: CFI ≈ 0.96, RMSEA ≈ 0.08), test-retest reliability (coefficients between .73 and .88 after ~7 weeks), known-groups validity, and sensitivity to change across time. Given their brevity, general wording (not tied to specific contexts), and robust psychometric properties, these measures are suitable for use across diverse settings, stakeholder groups, and intervention types.
Contact information is provided by the study sponsor or research team.
Universidad Europea de Valencia
Other
Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder: Study Protocol for a Randomized Controlled Trial.
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