NCT07449104

Brief Summary

In the context of therapy for Borderline Personality Disorder, our department had conduct a study titled "The Effectiveness of Dialectical Behavioral Group Psychotherapy Compared to Supportive Individual Psychotherapy in Patients with Borderline Personality Disorder: A Study of Therapeutic Alliance, Depression, Cognitive Function, Impulsivity, Suicide Risk, BDNF Levels, NFkB Levels, SOD Levels."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

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

December 16, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 21, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

PsychotherapyDBTtherapeutic alliancedepressioncognitive functionimpulsivitysuicide riskBDNFNFκBSODBPDSupportive psychotherapy

Outcome Measures

Primary Outcomes (5)

  • Therapeutic Alliances with California Psychotherapy Alliance Scales (CALPAS)

    California Psychotherapy Alliance Scales (CALPAS) score. A higher CALPAS (California Psychotherapy Alliance Scale) score indicates a stronger, more positive therapeutic alliance between a patient and their therapist. The California Psychotherapy Alliance Scale (CALPAS) uses a 7-point Likert scale for its 24 items, ranging from 1 ("not at all") to 7 ("very much so"). Minimum score 24 and maximum score 168.

    13 weeks

  • Depression with GRID Hamilton Depression Rating Scale (GRID HAM-D)

    GRID Hamilton Depression Rating Scale (GRID HAM-D) score, interval, higher total scores indicating greater severity of depression. Minimum Score: 0 (No depression) Maximum Score: 52 (Severe depression)

    13 weeks

  • cognitive function with Montreal Cognitive Assesment versi Indonesia (MoCA-Ina)

    Montreal Cognitive Assesment Indonesian version (MoCA-Ina) score, interval. A 30-point screening tool validated to detect mild cognitive impairment (MCI) and dementia in Indonesia, with a score of 26 or higher considered normal.

    13 weeks

  • impulsivity with Barrat Impulsiveness Scale (BIS11)

    Barrat Impulsiveness Scale (BIS11) score, interval, Higher scores indicate greater impulsivity, with 30-51 indicating low, 52-71 average, and 72+ high impulsivity.

    13 weeks

  • Suicide Risk with Columbia Suicide Severity Rating Scale (CSSRS)

    Columbia Suicide Severity Rating Scale (CSSRS) score, interval, Any "Yes" answer to behavior or ideation requires further clinical assessment.

    13 weeks

Secondary Outcomes (3)

  • NFkB Levels in ng/ml

    13 weeks

  • BDNF level in pg/ml

    13 weeks

  • SOD levels in ng/ml

    13 weeks

Study Arms (2)

DBT group psychotherapy

EXPERIMENTAL

13 weeks, one session per week. Each week, 2-hour dialectical therapy group session for 5 patients per group.

Behavioral: DBT group psychotherapy

Suportive psychotherapy

ACTIVE COMPARATOR

13 weeks, one session per week. Each week, one 30-minute session of individual supportive psychotherapy.

Behavioral: Supportive Psychotherapy

Interventions

13 weeks, one session per week. Each week, one 2-hour dialectical therapy group session for 5 patients in a group.

DBT group psychotherapy

13 weeks, one session per week. Each week, one 30-minute session of individual supportive psychotherapy

Suportive psychotherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-60 years old
  • Diagnosed with Borderline Personality Disorder based on the Structured Clinical Interview for DSM-V Axis II Disorders (SCID-II)
  • Junior high school education or higher
  • Patients willing to participate in the study.

You may not qualify if:

  • Taking immunosuppressive drugs since one week before the study.
  • Based on interviews or medical records, there is no history of post-stroke, epilepsy, or diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Faculty Diponegoro University

Semarang, Central Java, 50275, Indonesia

Location

Related Publications (1)

  • MacDowell KS, Marsa MD, Buenache E, Villatoro JML, Moreno B, Leza JC, Carrasco JL. Inflammatory and antioxidant pathway dysfunction in borderline personality disorder. Psychiatry Res. 2020 Feb;284:112782. doi: 10.1016/j.psychres.2020.112782. Epub 2020 Jan 11.

    PMID: 31955054BACKGROUND

Related Links

MeSH Terms

Conditions

Borderline Personality DisorderDepressionImpulsive Behavior

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • M.I. Widiastuti MIW Widiastuti, Prof. dr.PAK(K), Sp.S(K), M.Sc

    Medical Faculty Diponegoro University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Each patient was assigned an identification number, and the researcher who drew blood did not know whether the patient was in the treatment group or the control group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization was performed to assign the research sample to either the treatment group (Dialectical Behavior Therapy Group) or the control group (Supportive Individual Psychotherapy).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Psychiatry Residency Study Program Medical Faculty, Diponegoro University. Principal Investigator

Study Record Dates

First Submitted

February 21, 2026

First Posted

March 4, 2026

Study Start

December 16, 2021

Primary Completion

December 16, 2022

Study Completion

November 5, 2023

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The data are not publicly available due to privacy or ethical restrictions. The dataset involves sensitive information from minors regarding mental health, and sharing it publicly would compromise participant confidentiality as per the ethical approval obtained.

Locations