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NCT Number: NCT06882330

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

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

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Brno and Faculty of Medicine, Masaryk University

Brno, Czech Republic, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialectical behavior therapy

Behavioral

A complex psychotherapy program for patients with borderline personality disorder.

Primary outcomes

  1. Decrease of borderline symptoms

    Time frame: 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).

    significant decrease of symptoms measured by Borderline Symptoms List-23

  2. Decrease of self-injury incidents and suicidal attempts

    Time frame: 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.

    significant decrease of self-injury incidents and suicidal attempts assessed by semi-structured interview Lifetime - Suicide Attempt Self-Injury Count

Secondary outcomes

  1. Decrease in the number of days spent in the hospital

    Time frame: 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.

    significant decrease of days spent in the hospital assessed by semi-structured interview -Treatment History Interview

  2. Ecological momentary assessment of emotional variability

    Time frame: 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.

    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).

  3. Increase in reasons for living

    Time frame: 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).

    significant increase in reasons for living measured by Brief Reasons for Living Inventory 10

  4. Decrease of impulsivity

    Time frame: 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).

    significant decrease of impulsivity measured by UPPS-P questionnaire

  5. Increase of mindfulness

    Time frame: 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).

    sifnigicant increase of mindfulness measured by Five Facet Mindfulness Questionnaire

  6. Decrease of rejection sensitivity

    Time frame: 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).

    significant decrease of rejection sensitivity measured by Rejection Sensitivity RS-Adult questionnaire

  7. Decrease of dissociation symptoms

    Time frame: 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).

    significant decrease of dissociation symptoms measured by Multiscale Dissociation Inventory

  8. Decrease of anxiety

    Time frame: 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).

    significant decrease of anxiety symptoms measured by Beck Anxiety Inventory

  9. Decrease of depression ranking

    Time frame: 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).

    significant decrease of depression symptoms measured by Beck Depression Inventory II, and MADRS clinical rating

  10. Increase of emotion regulation

    Time frame: 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).

    significant increase of emotion regulation measured by Difficulties in emotion regulation scale, and ecological momentary assessment

  11. Changes in fMRI neural activity during "Faces task"

    Time frame: 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.

    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.

  12. Changes in fMRI neural activity during fMRI neurofeedback

    Time frame: 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.

    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.

  13. Changes in fMRI neural activity during Cyberball task

    Time frame: 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.

    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.

  14. Changes in frontal asymmetry during social exclusion measured by EEG

    Time frame: 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.

    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.

  15. Changes in ECG during fMRI

    Time frame: 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.

    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.

  16. Changes in skin conductance during fMRI

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Masarykova Univerzita

Other

Collaborators

  • Brno University Hospital
  • Masaryk University

Registry information

Acronym: NeuroDBT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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