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

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04829253
• Other study ID #: 210330008
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: November 2023

Study information

• Verified date: March 2021
• Source: Pontificia Universidad Catolica de Chile
• Contact: Alex J Behn, PhD
• Phone: +56942152484
• Email: albehn[@]uc.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: November 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

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.
• 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.

Locations

Country	Name	City	State
Chile	Complejo Asistencial Dr. Sótero del Río	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	University Diego Portales

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.