Borderline Personality Disorder (BPD)ANDESNCT07875166
Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder
A study testing Enhanced Dialectical Behavior Therapy Skills Training, Dialectical Behavior Therapy and Treatment as Usual (TAU) in people with Borderline Personality Disorder (BPD) and Dialectical Behavior Therapy, run by Hospital Dr Sotero del Rio at 7 sites in Chile.
Trial summary
Dialectical Behavior Therapy (DBT) holds the strongest empirical support for the treatment of Borderline Personality Disorder (BPD). However, in Chile-as in much of Latin America-the availability of DBT falls significantly short of meeting patient demand. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder (BPD), Dialectical Behavior Therapy, Public Health
- What is being tested?
- Enhanced Dialectical Behavior Therapy Skills Training, Dialectical Behavior Therapy and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 7 sitesChile
- Study dates
- 18 Jun 2025to Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet at least four criteria of BPD according to SCID-II
Who cannot join
- Antisocial Personality Disorder
- Substance Use Disorder
- Dialectical Behavior Therapy past 3 months
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Chile7 sites, 7 recruiting
- Recruiting
CECOSAM Padre Las Casas
Padre Las Casas, Araucania
- Recruiting
COSAM Puerto Montt
Port Montt, Los Lagos Region
- Recruiting
COSAM Reloncaví
Port Montt, Los Lagos Region
- Recruiting
COSAM La Pintana
Santiago, Santiago Metropolitan
- Recruiting
Hospital Dr. Sótero del Río
Santiago, Santiago Metropolitan
- Recruiting
CECOSAM Temuco
Temuco, Región Del La Araucanía
- Recruiting
Hospital Provincial del Huasco
Vallenar, Atacama
About this study
Official title: Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder: A Pragmatic, Multicenter, Randomized Non-inferiority Trial
Dialectical Behavior Therapy (DBT) holds the strongest empirical support for the treatment of Borderline Personality Disorder (BPD). However, in Chile-as in much of Latin America-the availability of DBT falls significantly short of meeting patient demand. Despite its demonstrated efficacy, the duration of DBT and its multicomponent structure pose challenges for implementation and dissemination, particularly within public healthcare settings.
This study aims to compare the clinical effectiveness of a 12-week DBT skills training group (12w-DBT-ST) with a quasi-standard 6-month DBT program (24w-DBT) and treatment as usual (TAU) for individuals with BPD in routine public mental health services. The primary hypothesis is that 12w-DBT-ST will be equivalent to the quasi-standard 24w-DBT and superior to TAU in reducing suicidal and self-harming behaviors.
- Conditions
- Borderline Personality Disorder (BPD), Dialectical Behavior Therapy, Public Health, Suicide Behavior, Self Harm
- Being tested
- Enhanced Dialectical Behavior Therapy Skills Training, Dialectical Behavior Therapy, Treatment as Usual (TAU)
- Keywords
- Borderline Personality Disorder, Dialectical Behavior Therapy, Suicide behavior, Nonsuicidal Self-Injury Disorder
- Medical subject headings
- Borderline Personality Disorder, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Dialectical Behavior Therapy Skills TrainingBehavioural
The intervention lasts 13 weeks and includes the following components: 1) Introductory Group for Orientation and Distress Tolerance DBT skills (2 hours per week during the first 4 weeks), Since week 2, weekly DBT skills-training group (2.5 hours; 12 weeks), 3) Weekly "check-in" phone calls throughout the 13 weeks, 4) Phone coaching for emergencies during business hours, 5) Weekly consultation team meeting (60.90 minutes)
Dialectical Behavior TherapyBehavioural
The intervention begins with a "pretreatment" phase consisting of three to four preparatory individual psychotherapy sessions in which the therapeutic goals are defined, commitment is established, and the patient is oriented to the rules and procedures of therapy. Pretreatment is followed by standard Dialectical Behavior Therapy over 24 weeks, comprising: 1) a weekly DBT skills-training group (2.5 hrs.); 2) weekly individual DBT psychotherapy (45 min.); 3) Access to phone coaching during business hours (although standard DBT considers 24/7 access, this study arm involves only office-hour access plus orientation to using National Hotline); 4) weekly consultation team meeting (60 min.).
Treatment as Usual (TAU)Behavioural
It corresponds to the standard treatment currently provided at any community mental health center in Chile, which consists of monthly or fortnightly individual standard psychotherapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Dialectical Behavior Therapy Skills Training | Experimental | Not described Receives: Behavioral: Enhanced Dialectical Behavior Therapy Skills Training |
| Dialectical Behavior Therapy | Active comparator | Not described Receives: Behavioral: Dialectical Behavior Therapy |
| Treatment as usual | Other | Not described Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (18)
General Psychopathology assessed by Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-10)
Global psychological distress assessed weekly with the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-10), self-reported through the study app. Total score range 0-40; higher scores indicate greater distress. The full weekly trajectory will be analysed and reported using mixed-effects growth curve models.
Measured: Weekly from baseline up to 6 months after the start of the allocated intervention
Borderline Symptom assessed by Borderline Symptom List (BSL-23)
Severity of borderline symptoms assessed weekly with the Borderline Symptom List (BSL-23), self-reported through the study app. Mean score range 0-4; higher scores indicate greater symptom severity. The full weekly trajectory will be analysed and reported using mixed-effects growth curve models.
Measured: Weekly from baseline up to 6 months after the start of the allocated intervention
Difficulties in Emotion Regulation Scale (DERS)
Measured: Baseline, 3 months, and 6 months
Dissociative Experiences Scale (DES)
Measured: Baseline, 3 months, and 6 months
Patient Health Questionnaire (PHQ-9)
Measured: Baseline, 3 months, and 6 months
International Trauma Questionnaire (ITQ)
The International Trauma Consortium (ITEM)
Measured: Baseline
Level of Personal Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0)
Measured: Baseline, 3 months, and 6 months
Personality Inventory for DSM-5 - Brief Form (PID-5-BF+)
Measured: Baseline, 3 months, and 6 months
Alcohol, Smoking and Substance Involvement Screening Test v.3.0 (ASSIST v3.0)
Measured: Baseline, 3 months, and 6 months
World Health Organization Disability Assessment Schedule 2.0 - 12-item version (WHODAS12)
Measured: Baseline, 3 months, and 6 months
The Recovering Quality of Life 10-item (ReQoL-10)
Measured: Baseline, 3 months, and 6 months
PROMIS Short Form v2.0 - Social Isolation 4a
Measured: Baseline, 3 months, and 6 months
Client Satisfaction Questionnaire (CSQ-8)
Measured: Baseline, 3 months, and 6 months
Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Measured: Baseline, 3 months, and 6 months
The Structured Clinical Interview for DSM-IV (SCID-II)
Measured: Baseline, and 6 months
Negative Affect assessed by "Positive Affect and Negative Affect Schedule" (PANAS)
Ecological Momentary Assessment (EMA)
Measured: Baseline, 3 months, and 6 months
Interpersonal reactiveness assessed by "Daily Stress Inventory" (DSI)
Ecological Momentary Assessment (EMA)
Measured: Baseline, 3 months, and 6 months
Self-concept assess by "Self-Concept Clarity Scale" (SCCS)
Ecological Momentary Assessment (EMA)
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start18 Jun 2025
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)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
- pragmatic, multicenter, randomized non-inferiority trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Dr Sotero del Rio
- Sponsor type
- University, hospital or other
- Collaborators
- MIDAP Millennium Institute for Research in Depression and Personality, Pontificia Universidad Catolica de Chile, Servicio de Salud Metropolitano Sur Oriente, University of Chile, Universidad de los Andes, Chile, Universidad del Desarrollo
- Responsible party
- Principal investigator, Matias Correa-Ramirez, Hospital Dr Sotero del Rio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875166
- Sponsor's protocol ID
- SA24I0184
- Acronym
- ANDES
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder: A Pragmatic, Multicenter, Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07875166
- Acronym / sponsor ID
- ANDES / SA24I0184
- Conditions
- Borderline Personality Disorder (BPD), Dialectical Behavior Therapy, Public Health, Suicide Behavior, Self Harm
- Keywords
- Borderline Personality Disorder, Dialectical Behavior Therapy, Suicide behavior, Nonsuicidal Self-Injury Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hospital Dr Sotero del RioUniversity, hospital or other
- Collaborators
- MIDAP Millennium Institute for Research in Depression and Personality, Pontificia Universidad Catolica de Chile, Servicio de Salud Metropolitano Sur Oriente, University of Chile, Universidad de los Andes, Chile, Universidad del Desarrollo
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Oct 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.
Dialectical Behavior Therapy (DBT) holds the strongest empirical support for the treatment of Borderline Personality Disorder (BPD). However, in Chile-as in much of Latin America-the availability of DBT falls significantly short of meeting patient demand. Despite its demonstrated efficacy, the duration of DBT and its multicomponent structure pose challenges for implementation and dissemination, particularly within public healthcare settings.
This study aims to compare the clinical effectiveness of a 12-week DBT skills training group (12w-DBT-ST) with a quasi-standard 6-month DBT program (24w-DBT) and treatment as usual (TAU) for individuals with BPD in routine public mental health services. The primary hypothesis is that 12w-DBT-ST will be equivalent to the quasi-standard 24w-DBT and superior to TAU in reducing suicidal and self-harming behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- pragmatic, multicenter, randomized non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Enhanced Dialectical Behavior Therapy Skills Training | Experimental | Behavioral: Enhanced Dialectical Behavior Therapy Skills Training |
| Dialectical Behavior Therapy | Active comparator | Behavioral: Dialectical Behavior Therapy |
| Treatment as usual | Other | Behavioral: Treatment as Usual (TAU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet at least four criteria of BPD according to SCID-II
Key exclusion criteria (3 listed)
- Antisocial Personality Disorder
- Substance Use Disorder
- Dialectical Behavior Therapy past 3 months
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 |
|---|---|---|
| Enhanced Dialectical Behavior Therapy Skills TrainingThe intervention lasts 13 weeks and includes the following components: 1) Introductory Group for Orientation and Distress Tolerance DBT skills (2 hours per week during the first 4 weeks), Since week 2, weekly DBT skills-training group (2.5 hours; 12 weeks), 3) Weekly "check-in" phone calls throughout the 13 weeks, 4) Phone coaching for emergencies during business hours, 5) Weekly consultation team meeting (60.90 minutes) | Behavioural | Enhanced Dialectical Behavior Therapy Skills Training |
| Dialectical Behavior TherapyThe intervention begins with a "pretreatment" phase consisting of three to four preparatory individual psychotherapy sessions in which the therapeutic goals are defined, commitment is established, and the patient is oriented to the rules and procedures of therapy. Pretreatment is followed by standard Dialectical Behavior Therapy over 24 weeks, comprising: 1) a weekly DBT skills-training group (2.5 hrs.); 2) weekly individual DBT psychotherapy (45 min.); 3) Access to phone coaching during business hours (although standard DBT considers 24/7 access, this study arm involves only office-hour access plus orientation to using National Hotline); 4) weekly consultation team meeting (60 min.). | Behavioural | Dialectical Behavior Therapy |
| Treatment as Usual (TAU)It corresponds to the standard treatment currently provided at any community mental health center in Chile, which consists of monthly or fortnightly individual standard psychotherapy sessions. | Behavioural | Treatment as usual |
Primary outcome
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, 3 months, and 6 months
18 secondary outcomes
General Psychopathology assessed by Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-10)
Time frame: Weekly from baseline up to 6 months after the start of the allocated intervention
Borderline Symptom assessed by Borderline Symptom List (BSL-23)
Time frame: Weekly from baseline up to 6 months after the start of the allocated intervention
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline, 3 months, and 6 months
Dissociative Experiences Scale (DES)
Time frame: Baseline, 3 months, and 6 months
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 3 months, and 6 months
International Trauma Questionnaire (ITQ)
Time frame: Baseline
Level of Personal Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0)
Time frame: Baseline, 3 months, and 6 months
Personality Inventory for DSM-5 - Brief Form (PID-5-BF+)
Time frame: Baseline, 3 months, and 6 months
Alcohol, Smoking and Substance Involvement Screening Test v.3.0 (ASSIST v3.0)
Time frame: Baseline, 3 months, and 6 months
World Health Organization Disability Assessment Schedule 2.0 - 12-item version (WHODAS12)
Time frame: Baseline, 3 months, and 6 months
The Recovering Quality of Life 10-item (ReQoL-10)
Time frame: Baseline, 3 months, and 6 months
PROMIS Short Form v2.0 - Social Isolation 4a
Time frame: Baseline, 3 months, and 6 months
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Baseline, 3 months, and 6 months
Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Time frame: Baseline, 3 months, and 6 months
The Structured Clinical Interview for DSM-IV (SCID-II)
Time frame: Baseline, and 6 months
Negative Affect assessed by "Positive Affect and Negative Affect Schedule" (PANAS)
Time frame: Baseline, 3 months, and 6 months
Interpersonal reactiveness assessed by "Daily Stress Inventory" (DSI)
Time frame: Baseline, 3 months, and 6 months
Self-concept assess by "Self-Concept Clarity Scale" (SCCS)
Time frame: Baseline, 3 months, and 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 15 Oct 2026.
Related trials for Borderline Personality Disorder (BPD)
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
RecruitingObservational study
Long Term Follow-up of Mentalization-Based Treatment: Exploring Variability in Outcomes, Long-term Value and Experiences 10+ Year After Receiving MBT Day Hospital or MBT Intensive Outpatient
Borderline Personality Disorder
Recruiting
Cognitive Reappraisal Training for Borderline Personality (BPD)
Borderline Personality Disorder
RecruitingObservational study
Symptom Assessment in Adolescents Placed on Child Welfare
Complex Post-Traumatic Stress Disorder (CPTSD), Borderline Personality Disorder (BPD)
Enrolling by invitation
Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study
Self-Harm, Deliberate, Suicidal Behavior
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Dialectical Behavior Therapy Skills Training, Dialectical Behavior Therapy and Treatment as Usual (TAU) in people with Borderline Personality Disorder (BPD) and Dialectical Behavior Therapy, run by Hospital Dr Sotero del Rio at 7 sites in Chile.
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 1 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Chile. 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 Matías Correa-Ramírez, MSc (+56225762300, matiascorrearamirez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia-Suicide Severity Rating Scale (C-SSRS) (time frame: Baseline, 3 months, and 6 months). 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 15 Oct 2026.