Adaptación cultural e implementación de DBT para adolescentes con trastornos emocionales
Adaptación cultural e implementación de un grupo de capacitación en habilidades de terapia dialéctica conductual para adolescentes con trastornos emocionales: un estudio de viabilidad y un ensayo controlado aleatorio
El objetivo de este estudio es saber si las habilidades de la terapia dialéctica conductual
Formación para Adolescentes (DBT-A-ST) trabaja sobre los trastornos emocionales en los adolescentes. Las principales preguntas que pretende responder son:
¿DBT-A-ST produce mejoras más rápidas (es decir, pendientes más pronunciadas), en comparación con ASG, en las medidas de resultado primarias y secundarias durante el tratamiento y el seguimiento a los 3 meses?
¿DBT-A-ST produce mayores mejoras, en comparación con ASG, en las medidas de resultado primarias y secundarias?
Los participantes:
Asignado aleatoriamente a (a) un DBT-A-ST culturalmente adaptado o (b) grupo de apoyo basado en actividades (ASG).
Recibió cinco evaluaciones antes del inicio del ensayo (T1), después de 4, 8 sesiones (T2, T3), en el postintervención (T4) y en el seguimiento a los 3 meses (T5).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Se llevará a cabo un ensayo controlado aleatorio en el departamento de psiquiatría infantil y adolescente de un centro médico. Los participantes de entre 12 y 17 años con trastornos depresivos o de ansiedad actuales diagnosticados mediante el K-SADS-E serán reclutados y asignados aleatoriamente 1:1 a uno de los dos brazos del estudio: a) grupo DBT-A-ST culturalmente adaptado, b) Grupo de apoyo basado en actividades. Ambas intervenciones son en formato grupal e incluyen 15 sesiones semanales de 120 min/cada sesión. Según el cálculo del poder, se incluirá un tamaño de muestra objetivo de 160 jóvenes. Las evaluaciones se realizarán antes de que comience el ensayo, en la cuarta y octava sesiones de tratamiento, al final y en el seguimiento a los 3 meses.
Los resultados primarios son la gravedad de la depresión y la ansiedad, calificadas por evaluadores ciegos. Los resultados secundarios incluyen psicopatología general, número de trastornos del DSM-5, calidad de vida y medidas autoinformadas. También se examinarán los mecanismos de tratamiento y los procesos de implementación.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hui-Chun Huang, Ph.D
- Número de teléfono: 3055 886-2-28094661
- Correo electrónico: aihch@mmh.org.tw
Ubicaciones de estudio
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Taipei, Taiwán
- Reclutamiento
- Mackay Memorial Hospital
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Contacto:
- Dr.Hui-Chun Huang
- Número de teléfono: 3055 886 2 28094661
- Correo electrónico: aihch@mmh.org.tw
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Taipei, Taiwán
- Activo, no reclutando
- Mackay Memorial Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- 12-17 años de edad,
- el consentimiento informado es proporcionado por el joven y uno de los padres,
- Dominio del idioma chino mandarín suficiente para completar el cuestionario de estudio.
- una puntuación total del PHQ-9 ≥ 10 o del GAD-7 ≥ 10,
- un diagnóstico actual de trastorno depresivo o de ansiedad en una entrevista K-SADS-E, incluida la depresión (F32-33); trastorno persistente del estado de ánimo (F34), trastorno de ansiedad fóbica (F40), otros trastornos de ansiedad (F41) y trastornos de adaptación (F43.2).
También se inscriben personas con diagnósticos comórbidos de varios trastornos emocionales. Las comorbilidades no se estratificarán porque esto aumentará significativamente la complejidad del diseño (es decir, algunos pacientes pueden tener múltiples diagnósticos comórbidos).
Criterios de exclusión:
- diagnósticos de discapacidad intelectual, esquizofrenia, trastorno generalizado del desarrollo, anorexia nerviosa y trastorno por uso de sustancias en los últimos 3 meses,
- Ideación suicida activa con un plan o antecedentes de riesgo de suicidio frecuente o reciente en los últimos 3 meses.
- TDAH sin elevaciones en las áreas de ansiedad, depresión o problemas de estrés en el CBCL,
- cambio reciente (últimas 4 semanas) en la medicación psiquiátrica o falta de voluntad para mantener una dosis estable de medicación durante la participación en el estudio,
- había recibido cinco o más sesiones de TCC en el pasado o no estaba dispuesto a suspender la psicoterapia concurrente,
- cualquier condición física o mental que requiera ingreso hospitalario,
- condición médica grave.
Como también aspiramos a un entorno naturalista, no excluimos a los pacientes que se someten a cambios de medicación durante el ensayo si el médico tratante lo considera necesario o clínicamente importante.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo DBT-A-ST culturalmente adaptado
El DBT-A-ST culturalmente adaptado consta de 15 sesiones grupales semanales, cada una de las cuales dura 120 minutos, incluido un descanso de 10 minutos. Mantiene los elementos centrales del estándar DBT-A, incluidos sus fundamentos filosóficos y estrategias de tratamiento. Los terapeutas se centran en enseñar habilidades DBT a través de varios métodos, como modelos, ensayos conductuales estructurados y retroalimentación. Cada sesión comienza con un ejercicio de atención plena en grupo de 40 minutos y una revisión de la tarea, seguido de 60 minutos dedicados a didáctica de habilidades específicas y actividades experienciales, y concluye con una tarea de 10 minutos. Dos líderes de grupo facilitan las sesiones y los participantes realizan un seguimiento diario del uso de sus habilidades con tarjetas de diario, que se revisan semanalmente. |
El DBT-A-ST culturalmente adaptado consta de 15 sesiones grupales semanales, cada una de las cuales dura 120 minutos, incluido un descanso de 10 minutos. Mantiene los elementos centrales del estándar DBT-A, incluidos sus fundamentos filosóficos y estrategias de tratamiento. Los terapeutas se centran en enseñar habilidades DBT a través de varios métodos, como modelos, ensayos conductuales estructurados y retroalimentación. Cada sesión comienza con un ejercicio de atención plena en grupo de 40 minutos y una revisión de la tarea, seguido de 60 minutos dedicados a didáctica de habilidades específicas y actividades experienciales, y concluye con una tarea de 10 minutos. Dos líderes de grupo facilitan las sesiones y los participantes realizan un seguimiento diario del uso de sus habilidades con tarjetas de diario, que se revisan semanalmente. |
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Youth Self Report (YSR)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hamilton Depression Scale-17 item (HAMD-17)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient Health Questionnaire-9 item (PHQ-9)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shen-Ing Liu, Ph.D, Mackay Memorial Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NSTC 113-2314-B-195 -012 -MY3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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