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

NCT ID: NCT06882330

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-27
• Study Completion Date: 2023-08-15

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.

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dialectical behavior therapy

Intervention Type: BEHAVIORAL

A complex psychotherapy program for patients with borderline personality disorder.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dialectical behavior therapy

A complex psychotherapy program for patients with borderline personality disorder.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

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

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:

• 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:

• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brno University Hospital

OTHER

Sponsor Role: collaborator

Masaryk University

OTHER

Sponsor Role: collaborator

Masarykova Univerzita

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavel Theiner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Brno

Locations

University Hospital Brno and Faculty of Medicine, Masaryk University

Brno, Czech Republic, Czechia

Countries

Czechia

Other Identifiers

NU20-04-00410

Identifier Type: -

Identifier Source: org_study_id