ClinicalTrials.gg
CompletedNCT07449104DBT BPDUpdated Mar 6, 2026

The Effectiveness of Dialectical Behavioral Group Psychotherapy Compared to Supportive Individual Psychotherapy In Patients With Borderline Personality Disorder: A Study on Therapeutic Alliance, Depression, Cognitive Function, Impulsivity, Suicide Risk, BDNF Levels, NFkB Levels, SOD Levels

An interventional study of DBT group psychotherapy and Supportive Psychotherapy in Borderline Personality Disorder (BPD), sponsored by Natalia Dewi Wardani, MD. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Natalia Dewi Wardani, MD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Dec 2021, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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."

Read the detailed description

Psychotherapy for Borderline Personality Disorder provided weekly for 13 weeks. Patients have given a logbooks. Researchers monitored patients weekly by telephone and monitor them during outpatient visits in the second, fourth, sixth, eighth, and twelfth weeks. Blood samples were taken before and 13 weeks after treatment. During the study, patients were advised not to consume any medications or herbal remedies outside of those prescribed by the doctor and recorded in the study.

02

Conditions studied

  • Borderline Personality Disorder (BPD)

Keywords

  • Psychotherapy
  • DBT
  • therapeutic alliance
  • depression
  • cognitive function
  • impulsivity
  • suicide risk
  • BDNF
  • NFκB
  • SOD
  • BPD
  • Supportive psychotherapy
03

In context

Borderline Personality Disorder

278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.

This study's enrollment of 66 is close to the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.

Browse Borderline Personality Disorder studies →

Lead sponsor

Natalia Dewi Wardani, MD is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Taking drugs since one week before the study.
  • Based on interviews or medical records, there is no history of post-stroke, epilepsy, or diabetes mellitus.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    DBT group psychotherapy

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

    Behavioral: DBT group psychotherapy

  • Active comparator
    Suportive psychotherapy

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

    Behavioral: Supportive Psychotherapy

Interventions

  • BehavioralDBT group psychotherapy

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

  • BehavioralSupportive Psychotherapy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 13 weeks

  2. 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)

    Time frame: 13 weeks

  3. 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.

    Time frame: 13 weeks

  4. 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.

    Time frame: 13 weeks

  5. 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.

    Time frame: 13 weeks

Secondary outcomes

  1. NFkB Levels in ng/ml

    ratio scale, nanogram/mililiter

    Time frame: 13 weeks

  2. BDNF level in pg/ml

    BDNF level in picogram/mililiter, ratio scale

    Time frame: 13 weeks

  3. SOD levels in ng/ml

    ratio scale, nanogram/mililiter

    Time frame: 13 weeks

07

Study locations

1 site
  • Medical Faculty Diponegoro University
    Semarang, Central Java 50275, Indonesia
08

References and documents

Publications

  • 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. PubMed 31955054 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07449104
Lead sponsor
Natalia Dewi Wardani, MD
Collaborators
Faculty of Medicine University of Diponegoro, Indonesia
Responsible party
Natalia Dewi Wardani, MD (Head of Psychiatry Residency Study Program Medical Faculty, Diponegoro University. Principal Investigator, Universitas Diponegoro) — Sponsor-investigator
First posted
Mar 4, 2026
Start date
Dec 16, 2021
Primary completion
Dec 16, 2022
Completion
Nov 5, 2023
Last update
Mar 6, 2026

Study contacts

M.I. Widiastuti MIW Widiastuti, Prof. dr.PAK(K), Sp.S(K), M.Sc
study chair · Medical Faculty Diponegoro University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion