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Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder.

2 luglio 2026 aggiornato da: Isabel Fernández Felipe, Universidad Europea de Valencia

Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder: Study Protocol for a Randomized Controlled Trial.

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

112

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: TAU
Trattamento come al solito
Comportamentale: TAU
Trattamento come al solito
Sperimentale: DBT LIVE
Identity disturbance skills based in DBT
Comportamentale: DBT LIVE
Identity disturbance skills based on DBT

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015)
Lasso di tempo: 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.
baseline; immediately after the intervention; 6 months
Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004); Spanish validation of Hervás & Jódar (2008).
Lasso di tempo: 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.
baseline; immediately after the intervention; 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-compassion Scale (SCS) (Neff, 2003); Spanish validation of García-Campayo et al. (2014).
Lasso di tempo: 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.
baseline; immediately after the intervention; 6 months
Meaning in Life Questionnaire (MLQ) (Steger et al., 2006); Spanish validation of Marco et al. (2022).
Lasso di tempo: 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.
baseline; immediately after the intervention; 6 months
Suicide Behaviors Questionnaire-Revised (SBQ-R) (Linehan, 1981); Spanish validation of García-Nieto et al. (2013).
Lasso di tempo: 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.
baseline; immediately after the intervention; 6 months
Level of Personal Functioning Scale (LPFS) (Bender et al., 2011); Spanish validation of Schetsche, (2021).
Lasso di tempo: 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.
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).
Lasso di tempo: 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.
baseline; immediately after the intervention; 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Europea de Valencia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

22 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DBTLIVERCT

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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