Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:47 PM
Study NCT ID:
NCT07449104
Status:
COMPLETED
Last Update Posted:
2026-03-06
First Post:
2026-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization was performed to assign the research sample to either the treatment group (Dialectical Behavior Therapy Group) or the control group (Supportive Individual Psychotherapy).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2023-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-21', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic Alliances with California Psychotherapy Alliance Scales (CALPAS)', 'timeFrame': '13 weeks', 'description': '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.'}, {'measure': 'Depression with GRID Hamilton Depression Rating Scale (GRID HAM-D)', 'timeFrame': '13 weeks', 'description': 'GRID Hamilton Depression Rating Scale (GRID HAM-D) score, interval, higher total scores indicating greater severity of depression.\n\nMinimum Score: 0 (No depression) Maximum Score: 52 (Severe depression)'}, {'measure': 'cognitive function with Montreal Cognitive Assesment versi Indonesia (MoCA-Ina)', 'timeFrame': '13 weeks', 'description': '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.'}, {'measure': 'impulsivity with Barrat Impulsiveness Scale (BIS11)', 'timeFrame': '13 weeks', 'description': 'Barrat Impulsiveness Scale (BIS11) score, interval, Higher scores indicate greater impulsivity, with 30-51 indicating low, 52-71 average, and 72+ high impulsivity.'}, {'measure': 'Suicide Risk with Columbia Suicide Severity Rating Scale (CSSRS)', 'timeFrame': '13 weeks', 'description': 'Columbia Suicide Severity Rating Scale (CSSRS) score, interval, Any "Yes" answer to behavior or ideation requires further clinical assessment.'}], 'secondaryOutcomes': [{'measure': 'NFkB Levels in ng/ml', 'timeFrame': '13 weeks', 'description': 'ratio scale, nanogram/mililiter'}, {'measure': 'BDNF level in pg/ml', 'timeFrame': '13 weeks', 'description': 'BDNF level in picogram/mililiter, ratio scale'}, {'measure': 'SOD levels in ng/ml', 'timeFrame': '13 weeks', 'description': 'ratio scale, nanogram/mililiter'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychotherapy', 'DBT', 'therapeutic alliance', 'depression', 'cognitive function', 'impulsivity', 'suicide risk', 'BDNF', 'NFκB', 'SOD', 'BPD', 'Supportive psychotherapy'], 'conditions': ['Borderline Personality Disorder (BPD)']}, 'referencesModule': {'references': [{'pmid': '31955054', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://digitepp.id/kep-detail/62', 'label': 'ethics committee RSUP dr.Kariadi website'}]}, 'descriptionModule': {'briefSummary': '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."', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-60 years old\n* Diagnosed with Borderline Personality Disorder based on the Structured Clinical Interview for DSM-V Axis II Disorders (SCID-II)\n* Junior high school education or higher\n* Patients willing to participate in the study.\n\nExclusion Criteria:\n\n* Taking immunosuppressive drugs since one week before the study.\n* Based on interviews or medical records, there is no history of post-stroke, epilepsy, or diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT07449104', 'acronym': 'DBT BPD', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Diponegoro'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '976/EC/KEPK-RSDK/2021'}, 'secondaryIdInfos': [{'id': '247/UN7.5.4/HK/2022', 'type': 'OTHER_GRANT', 'domain': 'Medical Faculty Diponegoro University Grant 2022'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DBT group psychotherapy', 'description': '13 weeks, one session per week. Each week, 2-hour dialectical therapy group session for 5 patients per group.', 'interventionNames': ['Behavioral: DBT group psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Suportive psychotherapy', 'description': '13 weeks, one session per week. Each week, one 30-minute session of individual supportive psychotherapy.', 'interventionNames': ['Behavioral: Supportive Psychotherapy']}], 'interventions': [{'name': 'DBT group psychotherapy', 'type': 'BEHAVIORAL', 'description': '13 weeks, one session per week. Each week, one 2-hour dialectical therapy group session for 5 patients in a group.', 'armGroupLabels': ['DBT group psychotherapy']}, {'name': 'Supportive Psychotherapy', 'type': 'BEHAVIORAL', 'description': '13 weeks, one session per week. Each week, one 30-minute session of individual supportive psychotherapy', 'armGroupLabels': ['Suportive psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50275', 'city': 'Semarang', 'state': 'Central Java', 'country': 'Indonesia', 'facility': 'Medical Faculty Diponegoro University', 'geoPoint': {'lat': -6.99306, 'lon': 110.42083}}], 'overallOfficials': [{'name': 'M.I. Widiastuti MIW Widiastuti, Prof. dr.PAK(K), Sp.S(K), M.Sc', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Faculty Diponegoro University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natalia Dewi Wardani, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Faculty of Medicine University of Diponegoro, Indonesia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Psychiatry Residency Study Program Medical Faculty, Diponegoro University. Principal Investigator', 'investigatorFullName': 'Natalia Dewi Wardani, MD', 'investigatorAffiliation': 'Universitas Diponegoro'}}}}