Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder.
2026年7月2日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
112
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Isabel Fernández Felipe
- 電話番号：+34 961 04 38 83
- メール：isabel.fernandez@universidadeuropea.es
研究場所
-
-
Valencia
-
Valencia、Valencia、スペイン、46010
- Valencia
-
コンタクト：
- Isabel Fernández Felipe
- 電話番号：+34 961 04 38 83
- メール：isabel.fernandez@universidadeuropea.es
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：タウ
通常通りの治療
|
通常通りの治療
|
|
実験的：DBT LIVE
Identity disturbance skills based in DBT
|
Identity disturbance skills based on DBT
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015)
時間枠：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).
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-compassion Scale (SCS) (Neff, 2003); Spanish validation of García-Campayo et al. (2014).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2028年6月1日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年6月22日
QC基準を満たした最初の提出物
2026年7月2日
最初の投稿 (実際)
2026年7月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月6日
QC基準を満たした最後の更新が送信されました
2026年7月2日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。