정서장애 청소년의 문화적 적응과 DBT 시행
2026년 9월 3일 업데이트: Shen-Ing,Liu, Mackay Memorial Hospital
정서 장애 청소년을 위한 변증법적 행동 치료 기술 훈련 그룹의 문화적 적응 및 구현: 타당성 조사 및 무작위 대조 시험
이 연구의 목표는 변증법적 행동치료 기술이 무엇인지 배우는 것입니다.
청소년을 위한 훈련(DBT-A-ST)은 청소년의 정서 장애에 대해 연구합니다. 답변하려는 주요 질문은 다음과 같습니다.
DBT-A-ST는 ASG에 비해 치료 및 3개월 추적 기간 동안 1차 및 2차 결과 측정에서 더 빠른 개선(즉, 더 가파른 기울기)을 제공합니까?
DBT-A-ST는 ASG에 비해 1차 및 2차 결과 측정에서 더 큰 개선을 제공합니까?
참가자는 다음을 수행합니다.
(a) 문화적으로 적응된 DBT-A-ST 또는 (b) 활동 기반 지원 그룹(ASG)에 무작위로 할당됩니다.
시험 시작 전(T1), 4, 8 세션 후(T2, T3), 중재 후(T4) 및 3개월 후속 조치(T5)에서 5번의 평가를 받았습니다.
연구 개요
상세 설명
무작위 대조 시험은 의료 센터의 아동 청소년 정신과에서 실시됩니다. K-SADS-E를 사용하여 진단된 현재 우울증 또는 불안 장애가 있는 12~17세 참가자를 모집하여 두 연구 부문 중 하나에 1:1로 무작위로 할당합니다. a) 문화적으로 적응된 DBT-A-ST 그룹, b) 활동 기반 지원 그룹. 두 중재 모두 그룹 형식이며 매주 15개의 세션, 각 세션당 120분으로 구성됩니다. 검정력 계산에 따르면 대상 표본 크기에는 청소년 160명이 포함됩니다. 평가는 임상시험 시작 전, 4차 및 8차 치료 세션, 마지막 치료 세션, 3개월 추적 관찰 시에 이루어집니다.
주요 결과는 블라인드 평가자가 평가한 우울증 및 불안의 심각도입니다. 이차 결과에는 일반적인 정신병리학, DSM-5 장애의 수, 삶의 질, 자가 보고 측정이 포함됩니다. 치료 메커니즘과 구현 프로세스도 검토됩니다.
연구 유형
중재적
등록 (추정된)
160
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Hui-Chun Huang, Ph.D
- 전화번호: 3055 886-2-28094661
- 이메일: aihch@mmh.org.tw
연구 장소
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Taipei, 대만
- 모병
- MacKay Memorial Hospital
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연락하다:
- Dr.Hui-Chun Huang
- 전화번호: 3055 886 2 28094661
- 이메일: aihch@mmh.org.tw
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Taipei, 대만
- 모집하지 않고 적극적으로
- MacKay Memorial Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 12~17세,
- 청소년과 부모 중 한 명이 사전 동의를 제공한 경우,
- 연구 설문지를 작성하기에 충분한 중국어 실력,
- PHQ-9≥ 10 또는 GAD-7 ≥ 10의 총점,
- 우울증을 포함한 K-SADS-E 인터뷰에서 현재 우울증 또는 불안 장애 진단을 받은 경우(F32-33) 지속성 기분 장애(F34), 공포성 불안 장애(F40), 기타 불안 장애(F41) 및 조정 장애(F43.2).
여러 정서 장애의 동반 진단을 받은 개인도 등록됩니다. 동반질환은 계층화되지 않습니다. 이는 설계의 복잡성을 크게 증가시키기 때문입니다(즉, 일부 환자는 여러 동반질환 진단을 받을 수 있습니다).
제외 기준:
- 지난 3개월 이내에 지적 장애, 정신분열증, 전반적 발달 장애, 신경성 식욕부진 및 약물 사용 장애 진단을 받은 경우,
- 지난 3개월 동안 빈번하거나 최근 자살 위험이 있는 계획 또는 이력이 있는 적극적인 자살 생각,
- CBCL의 불안, 우울증 또는 스트레스 문제 영역의 상승이 없는 ADHD,
- 최근(지난 4주) 정신과 약물의 변경 또는 연구 참여 중 약물의 안정적인 복용량을 유지하려는 의지가 없음,
- 과거에 5회 이상의 CBT 세션을 받았거나 동시 심리 치료를 중단할 의사가 없는 경우
- 병원 입원이 필요한 정신적 또는 신체적 상태,
- 심각한 건강 상태.
또한 자연주의적인 환경을 목표로 하기 때문에 치료 임상의가 이것이 필요하거나 임상적으로 중요하다고 판단하는 경우 임상 시험 중에 약물 변경을 받는 환자를 제외하지 않습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 문화적으로 적응된 DBT-A-ST 그룹
문화적으로 적응된 DBT-A-ST는 15개의 주간 그룹 세션으로 구성되며 각 세션은 10분 휴식을 포함하여 120분 동안 지속됩니다. 철학적 기초와 치료 전략을 포함하여 표준 DBT-A의 핵심 요소를 유지합니다. 치료사는 모델링, 구조화된 행동 리허설 및 피드백과 같은 다양한 방법을 통해 DBT 기술을 가르치는 데 중점을 둡니다. 각 세션은 40분간의 그룹 마음챙김 연습과 숙제 검토로 시작하고, 이어서 기술별 교훈과 체험 활동에 60분간 전념하고 10분간의 숙제로 마무리됩니다. 두 명의 그룹 리더가 세션을 진행하고 참가자는 매주 검토되는 일기 카드를 사용하여 매일 기술 사용을 추적합니다. |
문화적으로 적응된 DBT-A-ST는 15개의 주간 그룹 세션으로 구성되며 각 세션은 10분 휴식을 포함하여 120분 동안 지속됩니다. 철학적 기초와 치료 전략을 포함하여 표준 DBT-A의 핵심 요소를 유지합니다. 치료사는 모델링, 구조화된 행동 리허설 및 피드백과 같은 다양한 방법을 통해 DBT 기술을 가르치는 데 중점을 둡니다. 각 세션은 40분간의 그룹 마음챙김 연습과 숙제 검토로 시작하고, 이어서 기술별 교훈과 체험 활동에 60분간 전념하고 10분간의 숙제로 마무리됩니다. 두 명의 그룹 리더가 세션을 진행하고 참가자는 매주 검토되는 일기 카드를 사용하여 매일 기술 사용을 추적합니다. |
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위약 비교기: Satir-based group (SBG)
SBG, grounded in Satir's Iceberg Theory, aims to enhance self-awareness and communication by exploring participants' deeper emotions and beliefs.
Sessions include emotional sharing, communication skills training, and role-play exercises.
The program spans 15 weekly sessions (2 hours each): 12 for adolescents and 3 involving both adolescents and their parents.
Activities focus on practicing communication stances, reflection, and group discussion to foster personal growth and improved relationships.
The inclusion of parents is designed to help teens build supportive, resilient connections.
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SBG, grounded in Satir's Iceberg Theory, aims to enhance self-awareness and communication by exploring participants' deeper emotions and beliefs.
Sessions include emotional sharing, communication skills training, and role-play exercises.
The program spans 15 weekly sessions (2 hours each): 12 for adolescents and 3 involving both adolescents and their parents.
Activities focus on practicing communication stances, reflection, and group discussion to foster personal growth and improved relationships.
The inclusion of parents is designed to help teens build supportive, resilient connections.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Youth Self Report (YSR)
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Youth Self Report (YSR) is a self-reported measure assessing emotional and behavioral problems in adolescents. Each item is rated on a 3-point scale (0 = not true, 1 = sometimes true, 2 = mostly or completely true). The scale includes internalizing problems (withdrawal, anxiety/depression, and somatic complaints) and externalizing problems (rule-breaking and aggressive behaviors). Raw scores are converted to standardized T-scores based on normative data, with higher scores indicating more severe emotional and behavioral problems. T scores range approximately from 50 to 100, with scores above 70 indicating the clinical range. |
at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Child Behavior Checklist about their adolescents (CBCL)
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Child Behavior Checklist (CBCL) is used to assess behavioral and emotional problems in children and adolescents. Each item is rated on a 3-point Likert scale (0-2). Raw scores are converted to standardized T-scores based on age- and gender-specific norms, with higher scores indicating more severe behavioral and emotional problems. T scores of ≤59 indicate nonclinical symptoms, scores of 60-64 suggest a risk for problem behaviors, and scores ≥65 indicate clinically significant symptoms. |
at baseline, at 15 weeks, and at 3 months after completion of the intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Hamilton Depression Scale-17 item (HAMD-17)
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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HDRS-17 is a clinician-rated measure of depressive symptoms that consists of 17 items rated using a semi-structured interview.
Eight of the 17 HDRS-17 items are rated on a 5-point scale (0=absent; 1=doubtful or mild; 2=mild to moderate; 3=moderate to severe; 4=very severe), while the remaining 9 items are rated on a 3-point scale (0=absent; 1=doubtful or mild; 2=clearly present), yielding a minimum total score of 0 (least severe) and a maximum score of 52 (most severe).
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Hamilton Anxiety Scale (HAM-A)
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Hamilton Anxiety Scale (HAM-A) comprises 14 items.
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 indicates mild to moderate severity, and 25-30 indicates moderate to severe severity.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Clinical Global Impressions-Severity (CGI-S)
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Clinical Global Impressions-Severity (CGI-S) is a standardized assessment tool used by clinicians to rate illness severity, monitor changes over time, and evaluate medication efficacy.
It is rated on a seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Clinical Global Impressions-Improvement (CGI-I)
기간: at 15 weeks, and at 3 months after completion of the intervention
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The Clinical Global Impression-Improvement (CGI-I) is a 7-point scale that measures the extent to which the patient's illness has improved or worsened relative to baseline at the start of treatment.
It is rated on a scale from 1 to 7: 1 = very much improved since the beginning of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline (the start of treatment); 5 = minimally worse; 6 = much worse; 7 = very much worse since the start of treatment.
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at 15 weeks, and at 3 months after completion of the intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient Health Questionnaire-9 item (PHQ-9)
기간: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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It consists of nine items evaluating the presence of the nine DSM-5 criteria of major depression in the past 2 weeks.
Each item is scored 0-3.
Total scores indicate: 0-4 (None/Minimal), 5-9 (Mild), 10-14 (Moderate), 15-19 (Moderately Severe), and 20-27 (Severe).
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at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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Generalized Anxiety Disorder Scale-7 item (GAD-7)
기간: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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It is a self-report 7-item scale to measure the severity of anxiety and has been validated in Chinese adolescent populations.
The total scores of the GAD-7 range from 0 to 21, with the higher scores indicating higher severity of anxiety disorders.
For the cutoff points of the GAD-7 scores, in general, the scores of 5, 10, and 15 match categorization of none/normal (0-4), mild anxiety (5-9), moderate anxiety (10-14), and severe anxiety (15-21), respectively.
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at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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The number of the DSM-5 diagnoses
기간: at baseline, at 15weeks, and at 3 months after completion of the intervention
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The number of DSM-5 diagnoses is assessed using the Mandarin version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children - Epidemiologic version (K-SADS-E), modified to align with DSM-5 criteria.
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at baseline, at 15weeks, and at 3 months after completion of the intervention
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The Strengths and Difficulties Questionnaire (SDQ)
기간: Baseline
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It aims to evaluate emotional and behavioral challenges in children and adolescents, covering four problem areas: emotional symptoms, conduct issues, hyperactivity/inattention, and peer relationship difficulties.
All items are rated on a three-point scale (0=not true, 1=somewhat true, and 2=certainly true).
Five positively worded items from different SDQ difficulty scales are reverse-coded.
High scores on the difficulties scales indicate a high degree of difficulty; a high score on the prosocial scale indicates a high degree of prosocial behavior.
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Baseline
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10-item Positive and Negative Affect Schedule- Child/Parent (PANAS-C/P)
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The 10-item Positive and Negative Affect Schedule for Children/Parents (PANAS-C/P) is used to assess positive and negative emotional states in youth, based on self-report or parent-report of recent emotional experiences.
The measure yields two subscale scores: Positive Affect (range 10-50; higher scores indicate greater positive affect) and Negative Affect (range 10-50; lower scores indicate less negative affect).
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Perceived Stress Scale (PSS-10)
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Perceived Stress Scale (PSS) is a self-reported measure used to assess the degree to which individuals appraise situations in their lives as stressful.
Each item is rated on a 5-point Likert scale (0 = never to 4 = very often).
Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Scores of 0-13 indicate low stress, 14-26 indicate moderate stress, and 27-40 indicate high perceived stress.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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World Health Organization Quality of Life Scale, Brief Version (WHOQOL-BREF)
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The WHOQOL-BREF assesses quality of life across physical, psychological, social, and environmental domains.
Each item is rated on a 1-5 scale.
Domain scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
Interpretation is based on comparisons across domains, changes over time, and reference to population norms; lower scores (e.g., below the 30th percentile) may indicate areas requiring clinical attention.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Adult Self-Report (ASR)
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Adult Self-Report is a self-report instrument assessing behavioral, emotional, and social functioning over the past 6 months.
Items are rated on a 3-point scale (0 = not true, 1 = somewhat true, 2 = very true).
A Total Problems score is calculated by summing all problem items, with higher scores indicating greater overall difficulties.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Academic Pressure subscale of Inventory of Influencing Factors of Trait Anxiety
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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It includes 10 items that describe daily events related to students' academic pressure.
Each item is rated on a 5-point Likert scale ranging from 1 = never to 5 = always.
The items are averaged to calculate scale scores; the higher the average score, the higher the level of self-reported academic pressure.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Chinese Adolescent Life Event Scale checklist
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Stressful Life Events Scale assesses the occurrence of stressful life events.
In this study, only eight items related to controllable negative events are included.
Each item is rated as 0 = no, 1 = yes, and a Total Score is calculated by summing all items, ranging from 0 to 8, with higher scores indicating a greater number of stressful life events.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Treatment History Interview (THI)
기간: Baseline
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The Treatment History Questionnaire assesses the types and amounts of previous medical and psychological treatments received.
Items include self-reported hospital admissions, days in hospital, emergency department visits, medications, and outpatient psychosocial treatments.
Each item is rated 0 = no, 1 = yes, and a Total Score is calculated by summing all items, with higher scores indicating greater use of treatment resources.
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Baseline
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Emotion Regulation Questionnaire, Child and Adolescent Form (ERQ-C/A)
기간: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
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The Emotion Regulation Questionnaire for Children and Adolescents is a 10-item self-report measure assessing emotion regulation strategies, including cognitive reappraisal and emotion suppression.
Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree).
Subscale scores range from 6-30 for cognitive reappraisal and 4-20 for emotion suppression.
Higher scores indicate greater emotion dysregulation.
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at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
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The Distress tolerance Scale-Short Form (DTS-SF)
기간: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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The DTS-SF is a modification of the DTS and contains the highest-loading item from each subscale, forming a single DT factor.
As with the DTS, items are rated on a 5-point Likert scale (1 = strongly agree, 5 = strongly disagree), with lower scores indicating poorer ability to withstand and tolerate distress.
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at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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DBT skills subscale (DSS) of the DBT Ways of Coping Checklist
기간: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Dialectical Behavior Therapy Skills Use Scale is a 38-item self-report measure assessing the frequency of DBT skills use over the past month.
Participants rate how often they used specific skills when facing stressors on a 4-point scale (0 = never to 3 = regularly).
A Total Score (range: 0-114) is calculated by summing item scores, with higher scores indicating more frequent use of DBT skills.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Mindful Attention Awareness Scale-Children
기간: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
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The Mindful Attention Awareness Scale is a 15-item self-report measure assessing mindfulness across cognitive, emotional, physical, interpersonal, and general domains.
Items are rated on a 6-point scale (1 = almost always to 6 = almost never), reverse-scored, and averaged to yield a total score.
Higher scores indicate greater mindfulness.
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at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
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Group Climate Questionnaire-Short Form (GCQ-S)
기간: at 4, 8, and 15 weeks
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It is a 12-item self-report instrument used to measure youths' perceptions of the atmosphere in therapy groups.
It contains 12 items rated on a 7-point Likert scale, indicating the extent of agreement, ranging from "not at all" (0) to "extremely" (6).
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at 4, 8, and 15 weeks
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Therapy Alliance Scale for Adolescence
기간: Completed by adolescents: at 4, 8, and 15 weeks Completed by therapists: at 8 and 15 weeks
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It is widely used to measure therapeutic alliance in research with adolescent populations.
The higher the score, the better the therapeutic alliance.
Items are rated on a 4-point Likert scale ranging from 1 (Strongly Disagree) to 4 (Strongly Agree) and summed to create a single Total score with a maximum of 48.
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Completed by adolescents: at 4, 8, and 15 weeks Completed by therapists: at 8 and 15 weeks
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Client Satisfaction Questionnaire (CSQ-8)
기간: at 15 weeks
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It consists of eight questions (quality of service, kind of service, whether needs were met, likelihood to recommend to a friend, amount of help received, handling of problems, overall satisfaction, and likelihood to return), each rated on a 4-point Likert scale (1-4).
Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
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at 15 weeks
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Satisfaction of each session
기간: From the first group session to the final (15th) group session, satisfaction for each session was assessed immediately after each session.
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This 4-item, content-specific scale is completed by patients after each session using a 5-point Likert scale (1 = very unsatisfied to 5 = excellent).
Total scores range from 4 to 20, with higher scores indicating better session evaluation.
It is designed to facilitate collaborative adjustments to therapy, including the therapeutic alliance, session content, and relevance.
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From the first group session to the final (15th) group session, satisfaction for each session was assessed immediately after each session.
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The Adolescent Dialectical Behavior Therapy Group Skills Learning Experience Scale (ADBT-SLES)
기간: at 15 weeks
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The ADBT-SLES is a 12-item questionnaire assessing adolescents' perceived helpfulness of DBT group skills, rated on a 5-point Likert scale (1 = not helpful at all, 5 = extremely helpful).
It also includes four open-ended questions exploring participants' learning experiences in the group.
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at 15 weeks
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A short drop-out questionnaire
기간: at the time of participant withdrawal during the 15-session group treatment program (up to 15 sessions)
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It contains 6 questions (i.e., reason for drop-out, date of drop-out, number of sessions attended, person who initiated the stop of treatment) to gather information about drop-outs, which is filled in by adolescents.
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at the time of participant withdrawal during the 15-session group treatment program (up to 15 sessions)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Shen-Ing Liu, Ph.D, MacKay Memorial Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 10월 24일
기본 완료 (추정된)
2028년 7월 31일
연구 완료 (추정된)
2028년 7월 31일
연구 등록 날짜
최초 제출
2024년 8월 10일
QC 기준을 충족하는 최초 제출
2024년 8월 19일
처음 게시됨 (실제)
2024년 8월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 3일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NSTC 113-2314-B-195 -012 -MY3
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .