Neural Mechanisms of Dialectical Behavioral Therapy in Patients with Borderline Personality Disorder (NeuroDBT)

This research examines the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD).

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Dialectical behavior therapy

Detailed Description

This project aims to evaluate the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD). The project includes three subject groups: patients with BPD undergoing the DBT program (BPD-DBT), control patients with BPD on the waiting list for the program (BPD-control), and healthy controls (HC). Patients in the BPD-DBT group undergo a 24-week DBT program in an outpatient setting. All participants undergo a test battery comprising of self-report measures, clinical evaluation and fMRI and EEG measurement in the week before the DBT program beginning (T1), after 24 weeks (follow-up, T3), and at 24 weeks after T3 (follow-up, T4). The BPD-DBT group undergoes another assessment at T2 (after 12 weeks) to monitor selected symptoms during the DBT program by a short set of questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Brno, Czech Republic, 62500
    • University Hospital Brno and Faculty of Medicine, Masaryk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

BPD-DBT group:

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

Inclusion Criteria:

• 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

Exclusion Criteria:

• completing a DBT program or attending DBT-based therapy
• neurological disorder
• comorbid affective disorder or schizophrenia-related disorder
• intelligence quotient<70
• contraindications for MRI measurement
• pregnancy
• body mass index under 15

HC group:

Inclusion criteria:

• minimum age 16, informed consent of the patient
• informed consent of patient's legal representative in case of patients under age 18

Exclusion criteria:

• mental health problems
• history of self-injury or/and suicidal attempt
• neurological disorder
• intelligence quotient<70
• contraindications for MRI measurement
• pregnancy
• body mass index under 15

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPD-DBT group - patients undergoing DBT program.; Patients 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.	Behavioral: Dialectical behavior therapy; A complex psychotherapy program for patients with borderline personality disorder.
No Intervention: BPD-C group - patients undergoing treatment as usual (TAU); Patients 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).
No Intervention: HC group: healthy controls; Healthy 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in the number of days spent in the hospital	significant decrease of days spent in the hospital assessed by semi-structured interview -Treatment History Interview	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	EMA assesses respondents' emotions in their natural environment. They complete short questionnaires every hour from 9 AM to 9 PM for two days. First, they rate their ability to identify their current emotion (0-100). Then, they choose an emotion or select "An emotion I cannot name" / "No emotion." Next, they rate its intensity (0-100). Finally, they rate their control over the emotion and how overwhelming it feels (both 0-100).	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	significant increase in reasons for living measured by Brief Reasons for Living Inventory 10	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	significant decrease of impulsivity measured by UPPS-P questionnaire	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	sifnigicant increase of mindfulness measured by Five Facet Mindfulness Questionnaire	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 rejection sensitivity	significant decrease of rejection sensitivity measured by Rejection Sensitivity RS-Adult questionnaire	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 dissociation symptoms	significant decrease of dissociation symptoms measured by Multiscale Dissociation Inventory	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 anxiety	significant decrease of anxiety symptoms measured by Beck Anxiety Inventory	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 depression ranking	significant decrease of depression symptoms measured by Beck Depression Inventory II, and MADRS clinical rating	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 emotion regulation	significant increase of emotion regulation measured by Difficulties in emotion regulation scale, and ecological momentary assessment	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).
Changes in fMRI neural activity during "Faces task"	Significant changes in fMRI neural activity during the "Faces task". During the task, participants view images of faces expressing negative emotions or scrambled versions of the same images as a neutral control. The task is presented in pseudorandomized blocks, with each face displayed for a fixed duration. To maintain attention, participants respond based on the basis of face gender or frame color.	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.
Changes in fMRI neural activity during fMRI neurofeedback	fMRI neurofeedback is used to measure changes in fMRI neural activity. During fMRI neurofeedback, patients try to regulate their emotions according to the direction of the arrows (up or down). They receive feedback on how well they are regulating their emotions through a colour scale.	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.
Changes in fMRI neural activity during Cyberball task	The Cyberball task is used to measure changes in fMRI neural activity. Participants play a virtual ball-tossing game, believing they are interacting with two other players, though the game is pre-programmed. They control a hand on the screen to pass the ball, while the co-players are represented by animated figures with names and photographs to enhance ecological validity. There are three conditions: inclusion, exclusion, and overinclusion.	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.
Changes in frontal asymmetry during social exclusion measured by EEG	EEG is used to assess changes in frontal asymmetry during Cyberball task in fMRI. Frontal asymmetry: EEG alpha power localized in frontal scalp electrodes and differences between left and right hemisphere.	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.
Changes in ECG during fMRI	The Brain Products EEG/ExG system is used to assess heart rate variability. Heart rate variability: Mean R-R interval and standard deviation of R-R intervals evaluated in whole fMRI measurement in standard heart beats removing abnormal beats. R peaks detection performed in one channel recording localized on the chest.	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.
Changes in skin conductance during fMRI	The Brain Products EEG/ExG system is used to assess changes in skin conductance and monitor the participant's emotional state during the experimental measurement.	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.

Collaborators and Investigators

• Sponsor: Masarykova Univerzita
• Collaborators: Brno University Hospital; Masaryk University
• Investigators: Principal Investigator: Pavel Theiner, Ph.D., University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Borderline personality disorder; Dialectical behavior therapy; Therapy effectiveness
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: NU20-04-00410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD in anonymized form will be shared upon reasonable request after approval of principal investigator.
• IPD Sharing Time Frame: One year after publication of the results.
• IPD Sharing Access Criteria: Access requests can be submitted by email to Central contact person: Pavla Horká Linhartová.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No