- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07449104
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 (DBT BPD)
March 4, 2026 updated by: Natalia Dewi Wardani, MD
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."
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Central Java
-
Semarang, Central Java, Indonesia, 50275
- Medical Faculty Diponegoro University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DBT group psychotherapy
13 weeks, one session per week.
Each week, 2-hour dialectical therapy group session for 5 patients per group.
|
13 weeks, one session per week.
Each week, one 2-hour dialectical therapy group session for 5 patients in a group.
|
|
Active Comparator: Suportive psychotherapy
13 weeks, one session per week.
Each week, one 30-minute session of individual supportive psychotherapy.
|
13 weeks, one session per week.
Each week, one 30-minute session of individual supportive psychotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
impulsivity with Barrat Impulsiveness Scale (BIS11)
Time Frame: 13 weeks
|
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)
Time Frame: 13 weeks
|
Columbia Suicide Severity Rating Scale (CSSRS) score, interval, Any "Yes" answer to behavior or ideation requires further clinical assessment.
|
13 weeks
|
|
Therapeutic Alliances with California Psychotherapy Alliance Scales (CALPAS)
Time Frame: 13 weeks
|
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)
Time Frame: 13 weeks
|
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)
Time Frame: 13 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NFkB Levels in ng/ml
Time Frame: 13 weeks
|
ratio scale, nanogram/mililiter
|
13 weeks
|
|
BDNF level in pg/ml
Time Frame: 13 weeks
|
BDNF level in picogram/mililiter, ratio scale
|
13 weeks
|
|
SOD levels in ng/ml
Time Frame: 13 weeks
|
ratio scale, nanogram/mililiter
|
13 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: M.I. Widiastuti MIW Widiastuti, Prof. dr.PAK(K), Sp.S(K), M.Sc, Medical Faculty Diponegoro University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2021
Primary Completion (Actual)
December 16, 2022
Study Completion (Actual)
November 5, 2023
Study Registration Dates
First Submitted
February 21, 2026
First Submitted That Met QC Criteria
February 26, 2026
First Posted (Actual)
March 4, 2026
Study Record Updates
Last Update Posted (Actual)
March 6, 2026
Last Update Submitted That Met QC Criteria
March 4, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 976/EC/KEPK-RSDK/2021
- 247/UN7.5.4/HK/2022 (Other Grant/Funding Number: Medical Faculty Diponegoro University Grant 2022)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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