Borderline Personality Disorder (BPD)DBT BPDNCT07449104
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
A study testing DBT group psychotherapy and Supportive Psychotherapy in people with Borderline Personality Disorder (BPD), run by Natalia Dewi Wardani, MD at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Borderline Personality Disorder (BPD)
- What is being tested?
- DBT group psychotherapy and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Dec 2021to 5 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Medical Faculty Diponegoro University
Semarang, Central Java, 50275
About this study
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.
- Conditions
- Borderline Personality Disorder (BPD)
- Being tested
- DBT group psychotherapy, Supportive Psychotherapy
- Keywords
- Psychotherapy, DBT, therapeutic alliance, depression, cognitive function, impulsivity, suicide risk, BDNF, NFκB, SOD, BPD, Supportive psychotherapy
- Medical subject headings
- Borderline Personality Disorder, Depression, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT group psychotherapyBehavioural
13 weeks, one session per week. Each week, one 2-hour dialectical therapy group session for 5 patients in a group.
Supportive PsychotherapyBehavioural
13 weeks, one session per week. Each week, one 30-minute session of individual supportive psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| DBT group psychotherapy | Experimental | 13 weeks, one session per week. Each week, 2-hour dialectical therapy group session for 5 patients per group. Receives: Behavioral: DBT group psychotherapy |
| Suportive psychotherapy | Active comparator | 13 weeks, one session per week. Each week, one 30-minute session of individual supportive psychotherapy. Receives: Behavioral: Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 13 weeks
Secondary outcomes (3)
NFkB Levels in ng/ml
ratio scale, nanogram/mililiter
Measured: 13 weeks
BDNF level in pg/ml
BDNF level in picogram/mililiter, ratio scale
Measured: 13 weeks
SOD levels in ng/ml
ratio scale, nanogram/mililiter
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start16 Dec 2021
- Primary completion16 Dec 2022
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality Disorder (BPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization was performed to assign the research sample to either the treatment group (Dialectical Behavior Therapy Group) or the control group (Supportive Individual Psychotherapy).
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natalia Dewi Wardani, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Medicine University of Diponegoro, Indonesia
- Responsible party
- Sponsor-investigator, Natalia Dewi Wardani, MD, Universitas Diponegoro
- Investigators
- M.I. Widiastuti MIW Widiastuti, Prof. dr.PAK(K), Sp.S(K), M.Sc, Study chair, Medical Faculty Diponegoro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449104
- Sponsor's protocol ID
- 976/EC/KEPK-RSDK/2021
- Other IDs
- 247/UN7.5.4/HK/2022
- Acronym
- DBT BPD
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07449104
- Acronym / sponsor ID
- DBT BPD / 976/EC/KEPK-RSDK/2021
- Conditions
- Borderline Personality Disorder (BPD)
- Keywords
- Psychotherapy, DBT, therapeutic alliance, depression, cognitive function, impulsivity, suicide risk, BDNF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Natalia Dewi Wardani, MDUniversity, hospital or other
- Collaborators
- Faculty of Medicine University of Diponegoro, Indonesia
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization was performed to assign the research sample to either the treatment group (Dialectical Behavior Therapy Group) or the control group (Supportive Individual Psychotherapy).
| Arm | Type | Receives |
|---|---|---|
| DBT group psychotherapy | Experimental | Behavioral: DBT group psychotherapy13 weeks, one session per week. Each week, 2-hour dialectical therapy group session for 5 patients per group. |
| Suportive psychotherapy | Active comparator | Behavioral: Supportive Psychotherapy13 weeks, one session per week. Each week, one 30-minute session of individual supportive psychotherapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT group psychotherapy13 weeks, one session per week. Each week, one 2-hour dialectical therapy group session for 5 patients in a group. | Behavioural | DBT group psychotherapy |
| Supportive Psychotherapy13 weeks, one session per week. Each week, one 30-minute session of individual supportive psychotherapy | Behavioural | Suportive psychotherapy |
Primary outcome
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.
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)
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.
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.
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.
3 secondary outcomes
NFkB Levels in ng/ml
Time frame: 13 weeks
BDNF level in pg/ml
Time frame: 13 weeks
SOD levels in ng/ml
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 31955054MacDowell 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.
- ethics committee RSUP dr.Kariadi websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.I. Widiastuti MIW Widiastuti, Prof. dr.PAK(K), Sp.S(K), M.Sc study chair
Medical Faculty Diponegoro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT group psychotherapy and Supportive Psychotherapy in people with Borderline Personality Disorder (BPD), run by Natalia Dewi Wardani, MD at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Alliances with California Psychotherapy Alliance Scales (CALPAS) (time frame: 13 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07449104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.