Adaptação Cultural e Implementação de DBT para Adolescentes com Transtornos Emocionais
Adaptação cultural e implementação de grupo de treinamento de habilidades de terapia comportamental dialética para adolescentes com transtornos emocionais: um estudo de viabilidade e um ensaio clínico randomizado
O objetivo deste estudo é saber se as habilidades da terapia comportamental dialética
A Formação para Adolescentes (DBT-A-ST) atua nos distúrbios emocionais em adolescentes. As principais questões que pretende responder são:
O DBT-A-ST produz melhorias mais rápidas (ou seja, declives mais acentuados), em comparação com o ASG, nas medidas de resultados primários e secundários durante o tratamento e acompanhamento de 3 meses?
O DBT-A-ST produz maiores melhorias, em comparação com o ASG, nas medidas de resultados primários e secundários?
Os participantes irão:
Atribuído aleatoriamente a (a) um DBT-A-ST culturalmente adaptado ou (b) grupo de apoio baseado em atividades (ASG).
Recebeu cinco avaliações antes do início do ensaio (T1), após 4, 8 sessões (T2, T3), na pós-intervenção (T4) e no acompanhamento de 3 meses (T5).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Um ensaio clínico randomizado será conduzido no departamento de psiquiatria infantil e adolescente de um centro médico. Participantes de 12 a 17 anos com transtornos depressivos ou de ansiedade atuais diagnosticados usando o K-SADS-E serão recrutados e alocados aleatoriamente 1:1 para um dos dois braços do estudo: a) grupo DBT-A-ST culturalmente adaptado, b) Grupo de apoio baseado em atividades. Ambas as intervenções são em formato de grupo e incluem 15 sessões semanais, 120 min/cada sessão. Com base no cálculo do poder, será incluída uma amostra alvo de 160 jovens. As avaliações ocorrerão antes do início do ensaio, na 4ª e 8ª sessões de tratamento, no final e no acompanhamento de 3 meses.
Os resultados primários são a gravidade da depressão e da ansiedade, avaliada por avaliadores cegos. Os resultados secundários incluem psicopatologia geral, número de transtornos do DSM-5, qualidade de vida e medidas autorrelatadas. Os mecanismos de tratamento e os processos de implementação também serão examinados.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Hui-Chun Huang, Ph.D
- Número de telefone: 3055 886-2-28094661
- E-mail: aihch@mmh.org.tw
Locais de estudo
-
-
-
Taipei, Taiwan
- Recrutamento
- Mackay Memorial Hospital
-
Contato:
- Dr.Hui-Chun Huang
- Número de telefone: 3055 886 2 28094661
- E-mail: aihch@mmh.org.tw
-
Taipei, Taiwan
- Ativo, não recrutando
- Mackay Memorial Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
Critérios de inclusão:
- 12-17 anos de idade,
- o consentimento informado é fornecido pelo jovem e um dos pais,
- Proficiência na língua mandarim suficiente para preencher o questionário do estudo,
- uma pontuação total do PHQ-9≥ 10 ou do GAD-7 ≥ 10,
- um diagnóstico atual de transtorno depressivo ou de ansiedade em uma entrevista K-SADS-E, incluindo depressão (F32-33); transtorno de humor persistente (F34), transtorno de ansiedade fóbica (F40), outros transtornos de ansiedade (F41) e transtornos de adaptação (F43.2).
Indivíduos com diagnósticos comórbidos de diversos transtornos emocionais também estão inscritos. As comorbidades não serão estratificadas porque isso aumentará significativamente a complexidade do desenho (ou seja, alguns pacientes podem ter múltiplos diagnósticos de comorbidades).
Critérios de exclusão:
- diagnósticos de deficiência intelectual, esquizofrenia, transtorno invasivo do desenvolvimento, anorexia nervosa e transtorno por uso de substâncias nos últimos 3 meses,
- ideação suicida ativa com plano ou histórico de risco de suicídio frequente ou recente nos últimos 3 meses,
- TDAH sem elevações nas áreas de ansiedade, depressão ou problemas de estresse no CBCL,
- mudança recente (últimas 4 semanas) na medicação psiquiátrica ou falta de vontade de manter uma dosagem estável da medicação durante a participação no estudo,
- recebeu cinco ou mais sessões de TCC no passado ou não quis interromper a psicoterapia concomitante,
- qualquer condição mental ou física que exija internação hospitalar,
- condição médica grave.
Como também buscamos um ambiente naturalista, não excluímos pacientes que passam por mudanças de medicação durante o estudo se o médico responsável pelo tratamento julgar que isso é necessário ou clinicamente importante.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Grupo DBT-A-ST culturalmente adaptado
O DBT-A-ST culturalmente adaptado consiste em 15 sessões grupais semanais, cada uma com duração de 120 minutos, incluindo intervalo de 10 minutos. Ele mantém os elementos centrais do DBT-A padrão, incluindo seus fundamentos filosóficos e estratégias de tratamento. Os terapeutas se concentram no ensino de habilidades de DBT por meio de vários métodos, como modelagem, ensaios comportamentais estruturados e feedback. Cada sessão começa com um exercício de mindfulness em grupo de 40 minutos e revisão do dever de casa, seguido por 60 minutos dedicados à didática específica de habilidades e atividades experienciais, concluindo com uma tarefa de casa de 10 minutos. Dois líderes de grupo facilitam as sessões e os participantes monitoram diariamente o uso de suas habilidades com cartões diários, que são revisados semanalmente. |
O DBT-A-ST culturalmente adaptado consiste em 15 sessões grupais semanais, cada uma com duração de 120 minutos, incluindo intervalo de 10 minutos. Ele mantém os elementos centrais do DBT-A padrão, incluindo seus fundamentos filosóficos e estratégias de tratamento. Os terapeutas se concentram no ensino de habilidades de DBT por meio de vários métodos, como modelagem, ensaios comportamentais estruturados e feedback. Cada sessão começa com um exercício de mindfulness em grupo de 40 minutos e revisão do dever de casa, seguido por 60 minutos dedicados à didática específica de habilidades e atividades experienciais, concluindo com uma tarefa de casa de 10 minutos. Dois líderes de grupo facilitam as sessões e os participantes monitoram diariamente o uso de suas habilidades com cartões diários, que são revisados semanalmente. |
|
Comparador de Placebo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Youth Self Report (YSR)
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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
|
|
Child Behavior Checklist about their adolescents (CBCL)
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hamilton Depression Scale-17 item (HAMD-17)
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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).
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
Hamilton Anxiety Scale (HAM-A)
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
Clinical Global Impressions-Severity (CGI-S)
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
Clinical Global Impressions-Improvement (CGI-I)
Prazo: at 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at 15 weeks, and at 3 months after completion of the intervention
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient Health Questionnaire-9 item (PHQ-9)
Prazo: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
|
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).
|
at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
|
|
Generalized Anxiety Disorder Scale-7 item (GAD-7)
Prazo: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
|
|
The number of the DSM-5 diagnoses
Prazo: at baseline, at 15weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 15weeks, and at 3 months after completion of the intervention
|
|
The Strengths and Difficulties Questionnaire (SDQ)
Prazo: Baseline
|
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.
|
Baseline
|
|
10-item Positive and Negative Affect Schedule- Child/Parent (PANAS-C/P)
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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).
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
Perceived Stress Scale (PSS-10)
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
World Health Organization Quality of Life Scale, Brief Version (WHOQOL-BREF)
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
The Adult Self-Report (ASR)
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
Academic Pressure subscale of Inventory of Influencing Factors of Trait Anxiety
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
Chinese Adolescent Life Event Scale checklist
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
The Treatment History Interview (THI)
Prazo: Baseline
|
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.
|
Baseline
|
|
Emotion Regulation Questionnaire, Child and Adolescent Form (ERQ-C/A)
Prazo: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
|
|
The Distress tolerance Scale-Short Form (DTS-SF)
Prazo: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
|
|
DBT skills subscale (DSS) of the DBT Ways of Coping Checklist
Prazo: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
Mindful Attention Awareness Scale-Children
Prazo: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
|
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.
|
at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
|
|
Group Climate Questionnaire-Short Form (GCQ-S)
Prazo: at 4, 8, and 15 weeks
|
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).
|
at 4, 8, and 15 weeks
|
|
Therapy Alliance Scale for Adolescence
Prazo: Completed by adolescents: at 4, 8, and 15 weeks Completed by therapists: at 8 and 15 weeks
|
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.
|
Completed by adolescents: at 4, 8, and 15 weeks Completed by therapists: at 8 and 15 weeks
|
|
Client Satisfaction Questionnaire (CSQ-8)
Prazo: at 15 weeks
|
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.
|
at 15 weeks
|
|
Satisfaction of each session
Prazo: From the first group session to the final (15th) group session, satisfaction for each session was assessed immediately after each session.
|
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.
|
From the first group session to the final (15th) group session, satisfaction for each session was assessed immediately after each session.
|
|
The Adolescent Dialectical Behavior Therapy Group Skills Learning Experience Scale (ADBT-SLES)
Prazo: at 15 weeks
|
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.
|
at 15 weeks
|
|
A short drop-out questionnaire
Prazo: at the time of participant withdrawal during the 15-session group treatment program (up to 15 sessions)
|
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.
|
at the time of participant withdrawal during the 15-session group treatment program (up to 15 sessions)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shen-Ing Liu, Ph.D, Mackay Memorial Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NSTC 113-2314-B-195 -012 -MY3
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .