Neural Mechanisms of Dialectical Behavioral Therapy in Patients with Borderline Personality Disorder
NeuroDBT
1 other identifier
interventional
106
1 country
1
Brief Summary
This research examines the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedFirst Submitted
Initial submission to the registry
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 18, 2025
CompletedMarch 18, 2025
February 1, 2025
3 years
February 28, 2025
March 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Decrease of borderline symptoms
significant decrease of symptoms measured by Borderline Symptoms List-23
From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).
Decrease of self-injury incidents and suicidal attempts
significant decrease of self-injury incidents and suicidal attempts assessed by semi-structured interview Lifetime - Suicide Attempt Self-Injury Count
From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.
Secondary Outcomes (16)
Decrease in the number of days spent in the hospital
From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.
Ecological momentary assessment of emotional variability
From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.
Increase in reasons for living
From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).
Decrease of impulsivity
From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).
Increase of mindfulness
From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).
- +11 more secondary outcomes
Study Arms (3)
BPD-DBT group - patients undergoing DBT program.
EXPERIMENTALPatients with BPD undergoing Dialectical behavioral therapy (DBT) program with all the standard DBT modules (individual therapy 1 hour per week, skill groups 1.5 hours twice per week, phone coaching as needed, and consultation team 1.5 hours per week). The program lasts a total of 24 weeks in total including two 12-week runs of skills training. Four individual pretreatment sessions precede the program before the start of the main program part.
BPD-C group - patients undergoing treatment as usual (TAU)
NO INTERVENTIONPatients with BPD who are on the waiting list and who receive treatment as usual (typically standard individual psychotherapy not specifically focused on BPD treatment and/or psychiatric treatment).
HC group: healthy controls
NO INTERVENTIONHealthy controls matched to the BPD-DBT group for age and education. Participants without mental health problems and/or a history of self-harm or suicidal behavior. This group receives no psychotherapy or psychiatric treatment.
Interventions
A complex psychotherapy program for patients with borderline personality disorder.
Eligibility Criteria
You may qualify if:
- diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
- minimum age 16, informed consent of the patient
- informed consent of patient's legal representative in case of patients under age 18
- more than one self-injury incident and/or suicidal attempt in the past six months
You may not qualify if:
- neurological disorder
- comorbid affective disorder or schizophrenia-related disorder
- intelligence quotient\<70
- contraindications for MRI measurement
- pregnancy
- body mass index under 15
- BPD-C group:
- diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
- minimum age 16, informed consent of the patient
- informed consent of patient's legal representative in case of patients under age 18
- more than one self-injury incident and/or suicidal attempt in the past six months
- completing a DBT program or attending DBT-based therapy
- neurological disorder
- comorbid affective disorder or schizophrenia-related disorder
- intelligence quotient\<70
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Masarykova Univerzitalead
- Brno University Hospitalcollaborator
- Masaryk Universitycollaborator
Study Sites (1)
University Hospital Brno and Faculty of Medicine, Masaryk University
Brno, Czech Republic, 62500, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pavel Theiner, Ph.D.
University Hospital Brno
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2025
First Posted
March 18, 2025
Study Start
August 27, 2020
Primary Completion
August 10, 2023
Study Completion
August 15, 2023
Last Updated
March 18, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- One year after publication of the results.
- Access Criteria
- Access requests can be submitted by email to Central contact person: Pavla Horká Linhartová.
All IPD in anonymized form will be shared upon reasonable request after approval of principal investigator.