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

NCT04829253 | Unknown

• 1 other identifier: 210330008
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Depression Symptomatology measured through the Patient Health Questionnaire - PHQ-9

  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

  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

  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.

  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.

  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.

Study Arms (2)

b-DBT (Brief Dialectical Behavioral Therapy)

EXPERIMENTAL

3 months of and intensive modified DBT intervention.

Behavioral: Dialectical Behavior Therapy -3-months

s-DBT (standard Brief Dialectical Behavioral Therapy)

ACTIVE COMPARATOR

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

Dialectical Behavior Therapy -3-months BEHAVIORAL

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.

b-DBT (Brief Dialectical Behavioral Therapy)

Dialectical Behavior Therapy -6-months BEHAVIORAL

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.

s-DBT (standard Brief Dialectical Behavioral Therapy)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• University Diego Portales: collaborator

Study Sites (1)

Complejo Asistencial Dr. Sótero del Río

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Alex Behn, PhD

  Millennium Institute for Research in Depression and Personality

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex J Behn, PhD

CONTACT

+56942152484; albehn@uc.cl

Matias Correa, MD

CONTACT

+56995568763; matiascorrearamirez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will not be therapists in the study and will be blind to treatment allocation. The only exception involves assessors in charge of evaluating care usage (e.g. ER visits and inpatient) as they will probably find out the treatment condition. These assessors will not participate in the assessment of primary or other secondary outcome measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: November 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)