情緒障害のある青少年に対する文化適応と DBT の実施
2026年9月3日 更新者：Shen-Ing,Liu、Mackay Memorial Hospital
情緒障害のある青少年のための文化適応と弁証法的行動療法スキルトレーニンググループの実施：実現可能性研究とランダム化比較試験
この研究の目的は、弁証法的行動療法のスキルを学ぶことです。
青少年向けトレーニング (DBT-A-ST) は、青少年の感情障害に取り組んでいます。 回答することを目的とした主な質問は次のとおりです。
DBT-A-ST は、ASG と比較して、治療中および 3 か月の追跡調査中の一次および二次アウトカム測定において、より速い改善 (つまり、より急な傾き) をもたらしますか?
DBT-A-ST は、ASG と比較して、一次および二次結果の測定において大きな改善をもたらしますか?
参加者は次のことを行います:
(a) 文化的に適応した DBT-A-ST または (b) 活動ベースのサポート グループ (ASG) にランダムに割り当てられます。
試験開始前（T1）、4、8セッション後（T2、T3）、介入後（T4）、および3か月の追跡調査（T5）で5回の評価を受けました。
調査の概要
詳細な説明
ランダム化比較試験は医療センターの児童思春期精神科で実施される。 K-SADS-E を使用して診断された、現在うつ病または不安障害を患っている 12 ～ 17 歳の参加者が募集され、次の 2 つの研究群のいずれかに 1:1 でランダムに割り当てられます: a) 文化的に適応した DBT-A-ST グループ、b)活動ベースのサポートグループ。 どちらの介入もグループ形式で、毎週 15 回のセッション (各セッションあたり 120 分) が含まれます。 検出力の計算に基づいて、ターゲット サンプル サイズとして 160 人の若者が含まれます。 評価は治験開始前、4回目と8回目の治療セッション、最終回、そして3か月の追跡調査時に行われます。
主な結果は、盲目評価者によって評価されるうつ病と不安の重症度です。 副次的転帰には、一般的な精神病理、DSM-5 障害の数、生活の質、自己申告の測定値が含まれます。 治療メカニズムと実施プロセスも検討されます。
研究の種類
介入
入学 (推定)
160
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hui-Chun Huang, Ph.D
- 電話番号：3055 886-2-28094661
- メール：aihch@mmh.org.tw
研究場所
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Taipei、台湾
- 募集
- Mackay Memorial Hospital
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コンタクト：
- Dr.Hui-Chun Huang
- 電話番号：3055 886 2 28094661
- メール：aihch@mmh.org.tw
-
Taipei、台湾
- 積極的、募集していない
- Mackay Memorial Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 12～17歳、
- インフォームド・コンセントは青少年と親のいずれかによって提供されます。
- 研究アンケートに回答するのに十分な中国語能力、
- PHQ-9 ≥ 10 または GAD-7 ≥ 10 のいずれかの合計スコア、
- うつ病を含む、K-SADS-E 面接による現在のうつ病または不安障害の診断 (F32-33)。持続性気分障害 (F34)、恐怖性不安障害 (F40)、その他の不安障害 (F41)、および適応障害 (F43.2)。
いくつかの感情障害を併発していると診断された人も登録されています。 併存疾患は層別化されません。これは、設計の複雑さが大幅に増加するためです（つまり、一部の患者は複数の併存診断を有する可能性があります）。
除外基準:
- 過去3か月以内に知的障害、統合失調症、広汎性発達障害、神経性食欲不振症、薬物使用障害と診断された場合、
- 過去 3 か月以内に頻繁または最近の自殺の危険性がある計画または履歴を伴う積極的な自殺念慮、
- CBCLの不安、うつ病、またはストレス問題の領域の上昇がないADHD、
- 最近（過去4週間）精神科治療薬を変更した、または研究参加中に安定した投薬量を維持することを望まない、
- 過去にCBTのセッションを5回以上受けたことがある、または同時の心理療法を中止したくない、
- 入院を必要とする精神的または身体的状態、
- 重篤な病状。
また、私たちは自然主義的な環境を目指しているため、担当臨床医が必要または臨床的に重要であると判断した場合、治験中に投薬変更を受ける患者さんを除外しません。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：文化的に適応した DBT-A-ST グループ
文化的に適応された DBT-A-ST は、毎週 15 回のグループ セッションで構成され、各セッションは 10 分間の休憩を含む 120 分間続きます。 標準的な DBT-A の哲学的基礎や治療戦略などの核となる要素が維持されています。 セラピストは、モデリング、構造化された行動リハーサル、フィードバックなどのさまざまな方法を通じて DBT スキルを教えることに重点を置いています。 各セッションは、40 分間のグループでのマインドフルネス演習と宿題の復習から始まり、その後 60 分間スキル固有の指導と体験活動に専念し、10 分間の宿題で終わります。 2 人のグループ リーダーがセッションを進行し、参加者は日記カードでスキルの使用状況を毎日追跡し、毎週確認します。 |
文化的に適応された DBT-A-ST は、毎週 15 回のグループ セッションで構成され、各セッションは 10 分間の休憩を含む 120 分間続きます。 標準的な DBT-A の哲学的基礎や治療戦略などの核となる要素が維持されています。 セラピストは、モデリング、構造化された行動リハーサル、フィードバックなどのさまざまな方法を通じて DBT スキルを教えることに重点を置いています。 各セッションは、40 分間のグループでのマインドフルネス演習と宿題の復習から始まり、その後 60 分間スキル固有の指導と体験活動に専念し、10 分間の宿題で終わります。 2 人のグループ リーダーがセッションを進行し、参加者は日記カードでスキルの使用状況を毎日追跡し、毎週確認します。 |
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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Youth Self Report (YSR)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hamilton Depression Scale-17 item (HAMD-17)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient Health Questionnaire-9 item (PHQ-9)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Shen-Ing Liu, Ph.D、Mackay Memorial Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年10月24日
一次修了 (推定)
2028年7月31日
研究の完了 (推定)
2028年7月31日
試験登録日
最初に提出
2024年8月10日
QC基準を満たした最初の提出物
2024年8月19日
最初の投稿 (実際)
2024年8月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月8日
QC基準を満たした最後の更新が送信されました
2026年9月3日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。