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临床试验/NCT07449104
NCT07449104已完成不适用

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

Natalia Dewi Wardani, MD1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年12月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
impulsivity with Barrat Impulsiveness Scale (BIS11)

研究概览

简要总结

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."

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

DBT group psychotherapy

Experimental

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

干预措施: DBT group psychotherapy (Behavioral)

Suportive psychotherapy

Active Comparator

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

干预措施: Supportive Psychotherapy (Behavioral)

结局指标

主要结局

impulsivity with Barrat Impulsiveness Scale (BIS11)

时间窗: 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)

时间窗: 13 weeks

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

Therapeutic Alliances with California Psychotherapy Alliance Scales (CALPAS)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • NFkB Levels in ng/ml(13 weeks)
  • BDNF level in pg/ml(13 weeks)
  • SOD levels in ng/ml(13 weeks)

研究者

发起方
Natalia Dewi Wardani, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Natalia Dewi Wardani, MD

Head of Psychiatry Residency Study Program Medical Faculty, Diponegoro University. Principal Investigator

Universitas Diponegoro

研究点 (1)

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