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

NCT ID: NCT04829253

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2023-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

b-DBT (Brief Dialectical Behavioral Therapy)

3 months of and intensive modified DBT intervention.

Group Type: EXPERIMENTAL

Dialectical Behavior Therapy -3-months

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

Dialectical Behavior Therapy -6-months

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Diego Portales

OTHER

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Behn, PhD

Role: PRINCIPAL_INVESTIGATOR

Millennium Institute for Research in Depression and Personality

Locations

Complejo Asistencial Dr. Sótero del Río

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Central Contacts

Alex J Behn, PhD

Role: CONTACT

albehn@uc.cl

+56942152484

Matias Correa, MD

Role: CONTACT

matiascorrearamirez@gmail.com

+56995568763

Facility Contacts

Matías Correa, MD

Role: primary

Other Identifiers

210330008

Identifier Type: -

Identifier Source: org_study_id