NCT06882330

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 28, 2025

Last Update Submit

March 12, 2025

Conditions

Keywords

Dialectical behavior therapyBorderline personality disorderTherapy effectiveness

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.

EXPERIMENTAL

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

BPD-C group - patients undergoing treatment as usual (TAU)

NO INTERVENTION

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).

HC group: healthy controls

NO INTERVENTION

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.

Interventions

A complex psychotherapy program for patients with borderline personality disorder.

BPD-DBT group - patients undergoing DBT program.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

University Hospital Brno and Faculty of Medicine, Masaryk University

Brno, Czech Republic, 62500, Czechia

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Pavel Theiner, Ph.D.

    University Hospital Brno

    PRINCIPAL INVESTIGATOR

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

All IPD in anonymized form will be shared upon reasonable request after approval of principal investigator.

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.

Locations