Меню
Набор скоро начнётся NCT07684872

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

Без фазы С лечением Treatment 1:Dialectical Behavior Therapy (DBT) Treatment as Usual

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: DBT LIVE, TAU.
Кому может быть актуально
Состояния в реестре: Treatment 1:Dialectical Behavior Therapy (DBT), Treatment as Usual. Базовые параметры: от 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое DBT LIVE
    Identity disturbance skills based on DBT
  • Поведенческое TAU
    Treatment as usual

Первичные конечные точки

  • Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015) [Срок оценки: baseline; immediately after the intervention; 6 months]
  • Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004); Spanish validation of Hervás & Jódar (2008). [Срок оценки: baseline; immediately after the intervention; 6 months]
Вторичные конечные точки (5)
  • Self-compassion Scale (SCS) (Neff, 2003); Spanish validation of García-Campayo et al. (2014). [Срок оценки: baseline; immediately after the intervention; 6 months]
  • Meaning in Life Questionnaire (MLQ) (Steger et al., 2006); Spanish validation of Marco et al. (2022). [Срок оценки: baseline; immediately after the intervention; 6 months]
  • Suicide Behaviors Questionnaire-Revised (SBQ-R) (Linehan, 1981); Spanish validation of García-Nieto et al. (2013). [Срок оценки: baseline; immediately after the intervention; 6 months]
  • Level of Personal Functioning Scale (LPFS) (Bender et al., 2011); Spanish validation of Schetsche, (2021). [Срок оценки: 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). [Срок оценки: baseline; immediately after the intervention; 6 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Valencia — Valencia

Идентификаторы

NCT: NCT07684872 · DBTLIVERCT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗