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

Effectiveness of a Short and Telematic Version of Cognitive-behavioral Treatment for Borderline Personality Disorder: an Open-label, Non-inferiority Randomized Clinical

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Dialectical Behavior Therapy -3-months; Behavioral: Dialectical Behavior Therapy -6-months

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex J Behn, PhD; Phone Number: +56942152484; Email: albehn@uc.cl
• Study Contact Backup: Name: Matias Correa, MD; Phone Number: +56995568763; Email: matiascorrearamirez@gmail.com

Study Locations

• Chile
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile
      • Complejo Asistencial Dr. Sótero del Rio
      • Contact: Matías Correa, MD
      • Principal Investigator: Alex J Behn, PhD
      • Sub-Investigator: Matias Correa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: b-DBT (Brief Dialectical Behavioral Therapy); 3 months of and intensive modified DBT intervention.	Behavioral: Dialectical 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Symptomatology measured through the Patient Health Questionnaire - PHQ-9	Self-assessment of DMS-IV symptoms of depression.	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.
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	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.
Quality of life measured through the World Health Organization Quality of Life brief version; WHOQOL-BREF	Measures overall satisfaction with life	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.
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	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.
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	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.

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: University Diego Portales
• Investigators: Principal Investigator: Alex Behn, PhD, Millennium Institute for Research in Depression and Personality

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 210330008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share IPD at this point.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No