Clinical trial NCT04829253: Effectiveness of a Short and Telematic Version of Cognitive-behavioral Treatment for Borderline Personality Disorder
Official title: Effectiveness of a Short and Telematic Version of Cognitive-behavioral Treatment for Borderline Personality Disorder: an Open-label, Non-inferiority Randomized Clinical
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: University Diego Portales
First posted: 2021-04-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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.).

Primary outcomes:
measure: Change in Borderline Personality Disorder Symptoms as measured by the Zanarini Rating Scale for Borderline Personality Disorder - ZAN-BPD
timeFrame: 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.
measure: 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)
timeFrame: 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:
measure: Depression Symptomatology measured through the Patient Health Questionnaire - PHQ-9
timeFrame: 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.
measure: Reasons for Living measured though the RFL
timeFrame: 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.
measure: Quality of life measured through the World Health Organization Quality of Life brief version; WHOQOL-BREF
timeFrame: 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.
measure: Emergency Room Visit measured by the integrated electronic records.
timeFrame: 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.
measure: Psychiatric inpatient days measured by the integrated electronic records.
timeFrame: 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.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Complejo Asistencial Dr. Sótero del Río
state: Región Metropolitana
Study officials:
affiliation: Millennium Institute for Research in Depression and Personality
name: Alex Behn, PhD
role: PRINCIPAL_INVESTIGATOR
References: