Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DBT LIVE, TAU.
- Who it may be relevant to
- Registry conditions: Treatment 1:Dialectical Behavior Therapy (DBT), Treatment as Usual. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder: Study Protocol for a Randomized Controlled Trial.
Overview
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.
Interventions
- Behavioral DBT LIVE
Identity disturbance skills based on DBT - Behavioral TAU
Treatment as usual
Primary outcome measures
- Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015) [Time frame: baseline; immediately after the intervention; 6 months]
- Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004); Spanish validation of Hervás & Jódar (2008). [Time frame: baseline; immediately after the intervention; 6 months]
Secondary outcome measures (5)
- Self-compassion Scale (SCS) (Neff, 2003); Spanish validation of García-Campayo et al. (2014). [Time frame: baseline; immediately after the intervention; 6 months]
- Meaning in Life Questionnaire (MLQ) (Steger et al., 2006); Spanish validation of Marco et al. (2022). [Time frame: baseline; immediately after the intervention; 6 months]
- Suicide Behaviors Questionnaire-Revised (SBQ-R) (Linehan, 1981); Spanish validation of García-Nieto et al. (2013). [Time frame: baseline; immediately after the intervention; 6 months]
- Level of Personal Functioning Scale (LPFS) (Bender et al., 2011); Spanish validation of Schetsche, (2021). [Time frame: 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). [Time frame: baseline; immediately after the intervention; 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Valencia — Valencia
Identifiers
NCT: NCT07684872 · DBTLIVERCT