Clinical trial NCT06882330: Neural Mechanisms of Dialectical Behavioral Therapy in Patients with Borderline Personality Disorder
Official title: Neural Mechanisms of Dialectical Behavioral Therapy in Patients with Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Dialectical behavior therapy
Borderline personality disorder
Therapy effectiveness
Lead sponsor: Masarykova Univerzita
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
name: Masaryk University
First posted: 2025-03-18
Enrollment: 106
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease of borderline symptoms
timeFrame: 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).
measure: Decrease of self-injury incidents and suicidal attempts
timeFrame: 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:
measure: Decrease in the number of days spent in the hospital
timeFrame: 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.
measure: Ecological momentary assessment of emotional variability
timeFrame: 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.
measure: Increase in reasons for living
timeFrame: 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).
measure: Decrease of impulsivity
timeFrame: 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).
measure: Increase of mindfulness
timeFrame: 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).
measure: Decrease of rejection sensitivity
timeFrame: 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).
measure: Decrease of dissociation symptoms
timeFrame: 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).
measure: Decrease of anxiety
timeFrame: 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).
measure: Decrease of depression ranking
timeFrame: 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).
measure: Increase of emotion regulation
timeFrame: 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).
measure: Changes in fMRI neural activity during "Faces task"
timeFrame: 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.
measure: Changes in fMRI neural activity during fMRI neurofeedback
timeFrame: 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.
measure: Changes in fMRI neural activity during Cyberball task
timeFrame: 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.
measure: Changes in frontal asymmetry during social exclusion measured by EEG
timeFrame: 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.
measure: Changes in ECG during fMRI
timeFrame: 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.
measure: Changes in skin conductance during fMRI
timeFrame: 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.
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: University Hospital Brno and Faculty of Medicine, Masaryk University
Study officials:
affiliation: University Hospital Brno
name: Pavel Theiner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: