Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder: Study Protocol for a Randomized Controlled Trial.
| Registry | NCT07684872 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 112 (Estimated) |
| Sponsor | Universidad Europea de Valencia (Other) |
| Conditions | Treatment 1:Dialectical Behavior Therapy (DBT), Treatment as Usual |
| Interventions | DBT LIVE, TAU (Behavioral) |
| Dates | start 2027-01-01 (estimated), primary completion 2028-06-01 (estimated), completion 2028-12-31 (estimated), first posted 2026-07-06, last updated 2026-07-06 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Treatment 1:Dialectical Behavior Therapy (DBT) All trials for Treatment as Usual All trials of DBT LIVE All trials of TAU
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DBT LIVE | Experimental | Behavioral: DBT LIVE | Identity disturbance skills based in DBT |
| TAU | Active comparator | Behavioral: TAU | Treatment as usual |
Sex: All, ages: 16 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Valencia | Valencia, Valencia | Spain |