Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

2. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

112

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Tau
Behandlung wie gewohnt
Verhalten: Tau
Behandlung wie gewohnt
Experimental: DBT LIVE
Identity disturbance skills based in DBT
Verhalten: DBT LIVE
Identity disturbance skills based on DBT

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015)
Zeitfenster: 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).
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-compassion Scale (SCS) (Neff, 2003); Spanish validation of García-Campayo et al. (2014).
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universidad Europea de Valencia

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Januar 2027

Primärer Abschluss (Geschätzt)

1. Juni 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

22. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DBTLIVERCT

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Behandlung wie gewohnt

Klinische Studien zur Tau

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in United Kingdom

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren