Treatment 1:Dialectical Behavior Therapy (DBT)NCT07684872
Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder.
A study testing DBT LIVE and TAU in people with Treatment 1:Dialectical Behavior Therapy (DBT) and Treatment as Usual, run by Universidad Europea de Valencia at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Treatment 1:Dialectical Behavior Therapy (DBT), Treatment as Usual
- What is being tested?
- DBT LIVE and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Valencia
Valencia, Valencia, 46010
Isabel Fernández Felipe, +34 961 04 38 83, isabel.fernandez@universidadeuropea.es
About this study
Official title: 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.
- Being tested
- DBT LIVE, TAU
- Keywords
- DBT, dialectical behavior therapy, skills, identity, LIVE, borderline personality disorder
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT LIVEBehavioural
Identity disturbance skills based on DBT
TAUBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| DBT LIVE | Experimental | Identity disturbance skills based in DBT Receives: Behavioral: DBT LIVE |
| TAU | Active comparator | Treatment as usual Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015)
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.
Measured: baseline; immediately after the intervention; 6 months
Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004); Spanish validation of Hervás & Jódar (2008).
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.
Measured: baseline; immediately after the intervention; 6 months
Secondary outcomes (5)
Self-compassion Scale (SCS) (Neff, 2003); Spanish validation of García-Campayo et al. (2014).
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.
Measured: baseline; immediately after the intervention; 6 months
Meaning in Life Questionnaire (MLQ) (Steger et al., 2006); Spanish validation of Marco et al. (2022).
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.
Measured: baseline; immediately after the intervention; 6 months
Suicide Behaviors Questionnaire-Revised (SBQ-R) (Linehan, 1981); Spanish validation of García-Nieto et al. (2013).
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.
Measured: baseline; immediately after the intervention; 6 months
Level of Personal Functioning Scale (LPFS) (Bender et al., 2011); Spanish validation of Schetsche, (2021).
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.
Measured: 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).
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.
Measured: baseline; immediately after the intervention; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment 1:Dialectical Behavior Therapy (DBT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing two groups (DBT treatment VS TAU)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Fernández Felipe, Universidad Europea de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684872
- Sponsor's protocol ID
- DBTLIVERCT
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder: Study Protocol for a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07684872
- Acronym / sponsor ID
- DBTLIVERCT
- Keywords
- DBT, dialectical behavior therapy, skills, identity, LIVE, borderline personality disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Universidad Europea de ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Comparing two groups (DBT treatment VS TAU)
| Arm | Type | Receives |
|---|---|---|
| DBT LIVE | Experimental | Behavioral: DBT LIVEIdentity disturbance skills based in DBT |
| TAU | Active comparator | Behavioral: TAUTreatment as usual |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT LIVEIdentity disturbance skills based on DBT | Behavioural | DBT LIVE |
| TAUTreatment as usual | Behavioural | TAU |
Primary outcome
Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015)
Time frame: 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.
Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004); Spanish validation of Hervás & Jódar (2008).
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT LIVE and TAU in people with Treatment 1:Dialectical Behavior Therapy (DBT) and Treatment as Usual, run by Universidad Europea de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabel Fernández Felipe (+34 961 04 38 83, isabel.fernandez@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-concept and Identity Measure (SCIM) (Kaufman et al., 2015) (time frame: baseline; immediately after the intervention; 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.