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

Primary Purpose

Borderline Personality Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Dialectical Behavior Therapy -3-months
Dialectical Behavior Therapy -6-months
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • Complejo Asistencial Dr. Sótero del Río

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

b-DBT (Brief Dialectical Behavioral Therapy)

s-DBT (standard Brief Dialectical Behavioral Therapy)

Arm Description

3 months of and intensive modified DBT intervention.

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)

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2021
Last Updated
March 31, 2021
Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
University Diego Portales
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1. Study Identification

Unique Protocol Identification Number
NCT04829253
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
University Diego Portales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
b-DBT (Brief Dialectical Behavioral Therapy)
Arm Type
Experimental
Arm Description
3 months of and intensive modified DBT intervention.
Arm Title
s-DBT (standard Brief Dialectical Behavioral Therapy)
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy -3-months
Intervention Description
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
Intervention Name(s)
Dialectical Behavior Therapy -6-months
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Borderline Personality Disorder Symptoms as measured by the Zanarini Rating Scale for Borderline Personality Disorder - ZAN-BPD
Description
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.
Title
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)
Description
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 Outcome Measure Information:
Title
Depression Symptomatology measured through the Patient Health Questionnaire - PHQ-9
Description
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.
Title
Reasons for Living measured though the RFL
Description
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.
Title
Quality of life measured through the World Health Organization Quality of Life brief version; WHOQOL-BREF
Description
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.
Title
Emergency Room Visit measured by the integrated electronic records.
Description
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.
Title
Psychiatric inpatient days measured by the integrated electronic records.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex J Behn, PhD
Phone
+56942152484
Email
albehn@uc.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Matias Correa, MD
Phone
+56995568763
Email
matiascorrearamirez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Behn, PhD
Organizational Affiliation
Millennium Institute for Research in Depression and Personality
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Asistencial Dr. Sótero del Río
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matías Correa, MD
First Name & Middle Initial & Last Name & Degree
Alex J Behn, PhD
First Name & Middle Initial & Last Name & Degree
Matias Correa, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plans to share IPD at this point.

Learn more about this trial

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

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