CClinicalTrials.gg
Status unknownNCT04829253Updated Apr 2, 2021

Effectiveness of a Short and Telematic Version of Cognitive-behavioral Treatment for Borderline Personality Disorder

An interventional study of Dialectical Behavior Therapy -3-months and Dialectical Behavior Therapy -6-months in Borderline Personality Disorder, sponsored by Pontificia Universidad Catolica de Chile. Status unknown at 1 site in Chile. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-02.

Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Standard Dialectical Behavioral Therapy (DBT)is an effective treatment for Borderline Personality Disorder (BPD), particularly for patients with significant behavioral and affective dysregulation, including suicidality. However, DBT in its original format is delivered in 12 months, and even though currently there are shorter versions of the treatment being developed and tested, in the context of public mental health care in Chile a shorter, intensive and lighter version of the treatment is likely needed to help patients seeking help for BPD symptoms. This study will test whether a 3 month, intensive and simplified version of DBT is at least equivalent to standard six months DBT with all its components (skills training, individual therapy, coaching calls, and treatment-team consulting). 120 patients diagnosed with BPD we'll be randomly assigned to receive either the short, intensive 3-month intervention or the longer standard 6-month DBT intervention. Baseline measures will be taken pre-treatment, upon treatment completion, and at a 4-month follow-up. Session-to-session change in BPD symptoms will also be measured throughout the treatments. Primary outcomes for the study are BPD symptoms, frequency, and intensity of suicidal activity. Secondary outcome measures include depression scores, quality of life, and ER visits, and days in inpatient care.

02

Conditions studied

  • Borderline Personality Disorder
03

In context

Personality Disorders

336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.

This study's planned enrollment of 240 is above the median of 75 across 229 interventional studies indexed under Personality Disorders.

Browse Personality Disorders studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • BPD diagnosis according to DSM-IV criteria, evaluated through a SCID-II structured interview.
  • History of suicide attempt or self-harm operationalized as at least two episodes of suicide or self-harm in the last 24 months
  • Provide signed informed consent to participate in the study.
  • Participant has not received more than 8 weeks of DBT in the past 24 months.

Exclusion criteria

Exclusion Criteria:

  • Fulfill diagnostic criteria for psychotic disorders classified in ICD-10 (F20-F29), evaluated through the MINI interview.
  • Diagnosis of Antisocial Personality Disorder evaluated through the SCID-II.
  • Active substance use disorder within the last 3 months, assessed by ASSIST.
  • Harmful use or problem dependence on alcohol assessed through AUDIT.
  • Meet criteria for Bipolar Affective Disorder type I assessed through the MINI Mania module.
  • Significant cognitive impairment assessed through Moca (Moca> 21).
  • Diagnosis recorded in the clinical record of intellectual-cognitive disability.
  • Recording in the clinical record of medical or surgical problems that could imply a probable hospitalization within one year of the start of the study (for example, cancer, coronary heart disease, etc.).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    b-DBT (Brief Dialectical Behavioral Therapy)

    3 months of and intensive modified DBT intervention.

    Behavioral: Dialectical Behavior Therapy -3-months

  • Active comparator
    s-DBT (standard Brief Dialectical Behavioral Therapy)

    6 months of a standard DBT intervention (this is a shorter version of the original 12-month DBT, but includes all four active components delivered over 6 months)

    Behavioral: Dialectical Behavior Therapy -6-months

Interventions

  • BehavioralDialectical Behavior Therapy -3-months

    Modification of affect regulation, behavioral regulation, interpersonal functioning and identity functioning through the use of skills training, phone check-ins, crisis management and individual initial assessment.

  • BehavioralDialectical Behavior Therapy -6-months

    Modification of affect regulation, behavioral regulation, interpersonal functioning and identity functioning through the use of skills training, individual psychotherapy, coaching calls and treatment-team consultation.

06

What researchers measure

Primary outcomes

  1. Change in Borderline Personality Disorder Symptoms as measured by the Zanarini Rating Scale for Borderline Personality Disorder - ZAN-BPD

    We will capture incremental change in affect dysregulation, behavioral dysregulation, interpersonal functioning, and cognitive/self functioning

    Time frame: Administered pre-treatment and then weekly until 3 months or 6 months depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.

  2. Change in the intensity and frequency of suicidal and self-harming activity, measured by a Spanish version of the Suicide Attempt Self-Injury Interview (SASII)

    Assessment recovers detailed information about frequency, topography, severity, social context, intent, precipitating events, concurrent events and outcomes of suicidal and self-harming behavior during a three-month period.

    Time frame: Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.

Secondary outcomes

  1. Depression Symptomatology measured through the Patient Health Questionnaire - PHQ-9

    Self-assessment of DMS-IV symptoms of depression.

    Time frame: Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.

  2. Reasons for Living measured though the RFL

    Self-report scale that measures reasons an individual has to live and thus prevents him/her from potentially engaging in suicidal activity

    Time frame: Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.

  3. Quality of life measured through the World Health Organization Quality of Life brief version; WHOQOL-BREF

    Measures overall satisfaction with life

    Time frame: Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.

  4. Emergency Room Visit measured by the integrated electronic records.

    Indicates number of visits to the ER in a target 3 month period as documented in electronic records

    Time frame: Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.

  5. Psychiatric inpatient days measured by the integrated electronic records.

    Indicates number of days spent in psychiatric inpatient care in a target 3 month period as documented in electronic records

    Time frame: Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.

07

Study locations

1 site
  • Complejo Asistencial Dr. Sótero del Río
    Santiago, Región Metropolitana, Chile
    • Matías Correa, MD · Contact
    • Alex J Behn, PhD · Principal investigator
    • Matias Correa, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No — No plans to share IPD at this point.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04829253
Lead sponsor
Pontificia Universidad Catolica de Chile
Collaborators
University Diego Portales
Responsible party
Sponsor
First posted
Apr 2, 2021
Start date
Nov 2021 (estimated)
Primary completion
Aug 2023 (estimated)
Completion
Nov 2023 (estimated)
Last update
Apr 2, 2021

Study contacts

Alex J Behn, PhD
Contact
albehn@uc.cl
+56942152484
Matias Correa, MD
Contact
matiascorrearamirez@gmail.com
+56995568763
Alex Behn, PhD
principal investigator · Millennium Institute for Research in Depression and Personality

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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