Adattamento culturale e implementazione della DBT per adolescenti con disturbi emotivi
Gruppo di formazione sull'adattamento culturale e l'implementazione di competenze di terapia dialettica comportamentale per adolescenti con disturbi emotivi: uno studio di fattibilità e uno studio randomizzato e controllato
L'obiettivo di questo studio è apprendere le competenze della terapia dialettica comportamentale
Il Training for Adolescents (DBT-A-ST) lavora sui disturbi emotivi negli adolescenti. Le principali domande a cui si propone di rispondere sono:
La DBT-A-ST produce miglioramenti più rapidi (cioè pendenze più ripide), rispetto all’ASG, sulle misure di esito primario e secondario durante il trattamento e il follow-up a 3 mesi?
La DBT-A-ST produce miglioramenti maggiori, rispetto all’ASG, sulle misure di esito primarie e secondarie?
I partecipanti:
Assegnato in modo casuale a (a) un DBT-A-ST culturalmente adattato o (b) un gruppo di supporto basato sulle attività (ASG).
Hanno ricevuto cinque valutazioni prima dell'inizio dello studio (T1), dopo 4, 8 sessioni (T2, T3), dopo l'intervento (T4) e a 3 mesi di follow-up (T5).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Uno studio randomizzato e controllato sarà condotto nel dipartimento di psichiatria infantile e adolescenziale di un centro medico. I partecipanti di età compresa tra 12 e 17 anni con attuali disturbi depressivi o d'ansia diagnosticati utilizzando il K-SADS-E verranno reclutati e assegnati in modo casuale 1: 1 a uno dei due bracci di studio: a) gruppo DBT-A-ST culturalmente adattato, b) Gruppo di supporto basato sulle attività. Entrambi gli interventi sono in formato di gruppo e comprendono 15 sessioni settimanali, 120 minuti/ciascuna sessione. Sulla base del calcolo della potenza, verrà incluso un campione target di 160 giovani. Le valutazioni avverranno prima dell'inizio dello studio, alla 4a e all'8a sessione di trattamento, alla fine, e al follow-up a 3 mesi.
I risultati primari sono la gravità della depressione e dell'ansia, valutata da valutatori ciechi. Gli esiti secondari includono la psicopatologia generale, il numero di disturbi del DSM-5, la qualità della vita e le misure auto-riferite. Verranno inoltre esaminati i meccanismi di trattamento e i processi di attuazione.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Hui-Chun Huang, Ph.D
- Numero di telefono: 3055 886-2-28094661
- Email: aihch@mmh.org.tw
Luoghi di studio
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Taipei, Taiwan
- Reclutamento
- Mackay Memorial Hospital
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Contatto:
- Dr.Hui-Chun Huang
- Numero di telefono: 3055 886 2 28094661
- Email: aihch@mmh.org.tw
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Taipei, Taiwan
- Attivo, non reclutante
- Mackay Memorial Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
Criteri di inclusione:
- 12-17 anni,
- il consenso informato è fornito dal giovane e da uno dei genitori,
- Conoscenza della lingua cinese mandarino sufficiente per completare il questionario di studio,
- un punteggio totale di PHQ-9≥ 10 o GAD-7 ≥ 10,
- una diagnosi attuale di disturbo depressivo o d'ansia da un'intervista K-SADS-E, inclusa la depressione (F32-33); disturbo dell'umore persistente (F34), disturbo d'ansia fobico (F40), altri disturbi d'ansia (F41) e disturbi dell'adattamento (F43.2).
Vengono arruolati anche individui con diagnosi di comorbilità di diversi disturbi emotivi. Le comorbidità non saranno stratificate perché ciò aumenterebbe significativamente la complessità del disegno (vale a dire, alcuni pazienti potrebbero avere diagnosi multiple di comorbilità).
Criteri di esclusione:
- diagnosi di disabilità intellettiva, schizofrenia, disturbo pervasivo dello sviluppo, anoressia nervosa e disturbo da uso di sostanze negli ultimi 3 mesi,
- ideazione suicidaria attiva con un piano o una storia di rischio di suicidio frequente o recente negli ultimi 3 mesi,
- ADHD senza aumenti nelle aree di ansia, depressione o problemi di stress sul CBCL,
- cambiamento recente (nelle ultime 4 settimane) dei farmaci psichiatrici o riluttanza a mantenere un dosaggio stabile di farmaci durante la partecipazione allo studio,
- aveva ricevuto cinque o più sessioni di CBT in passato o non era disposto a interrompere la psicoterapia concomitante,
- qualsiasi condizione mentale o fisica che richieda il ricovero ospedaliero,
- grave condizione medica.
Poiché puntiamo anche a un contesto naturalistico, non escludiamo i pazienti che si sottopongono a modifiche del farmaco durante lo studio se il medico curante lo ritiene necessario o clinicamente importante.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Gruppo DBT-A-ST culturalmente adattato
Il DBT-A-ST adattato culturalmente consiste in 15 sessioni di gruppo settimanali, ciascuna della durata di 120 minuti, inclusa una pausa di 10 minuti. Mantiene gli elementi fondamentali della DBT-A standard, compresi i suoi fondamenti filosofici e le strategie di trattamento. I terapisti si concentrano sull'insegnamento delle abilità DBT attraverso vari metodi come modelli, prove comportamentali strutturate e feedback. Ogni sessione inizia con un esercizio di consapevolezza di gruppo di 40 minuti e una revisione dei compiti, seguiti da 60 minuti dedicati a didattiche e attività esperienziali specifiche per abilità, per concludere con un'assegnazione di compiti a casa di 10 minuti. Due leader del gruppo facilitano le sessioni e i partecipanti monitorano quotidianamente l'utilizzo delle proprie competenze con schede di diario, che vengono riviste settimanalmente. |
Il DBT-A-ST adattato culturalmente consiste in 15 sessioni di gruppo settimanali, ciascuna della durata di 120 minuti, inclusa una pausa di 10 minuti. Mantiene gli elementi fondamentali della DBT-A standard, compresi i suoi fondamenti filosofici e le strategie di trattamento. I terapisti si concentrano sull'insegnamento delle abilità DBT attraverso vari metodi come modelli, prove comportamentali strutturate e feedback. Ogni sessione inizia con un esercizio di consapevolezza di gruppo di 40 minuti e una revisione dei compiti, seguiti da 60 minuti dedicati a didattiche e attività esperienziali specifiche per abilità, per concludere con un'assegnazione di compiti a casa di 10 minuti. Due leader del gruppo facilitano le sessioni e i partecipanti monitorano quotidianamente l'utilizzo delle proprie competenze con schede di diario, che vengono riviste settimanalmente. |
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Comparatore 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.
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Youth Self Report (YSR)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Hamilton Depression Scale-17 item (HAMD-17)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Patient Health Questionnaire-9 item (PHQ-9)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Shen-Ing Liu, Ph.D, Mackay Memorial Hospital
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Inizio studio (Effettivo)
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Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NSTC 113-2314-B-195 -012 -MY3
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