Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders

NCT06566235 | Recruiting

• 1 other identifier: NSTC 113-2314-B-195 -012 -MY3
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to learn if Dialectical behavior therapy Skills Training for Adolescents (DBT-A-ST) works on emotional disorders in adolescents. The main questions it aims to answer are: Does DBT-A-ST produce faster improvements (i.e., steeper slopes), compared to ASG, on primary and secondary outcome measures during treatment and 3-month follow-up? Does DBT-A-ST produce greater improvements, compared to ASG, on primary and secondary outcome measures? Participants will: Randomly assigned to (a) a culturally adapted DBT-A-ST or (b) activities-based support group (ASG). Received five assessments before the start of the trial (T1), after 4, 8 sessions (T2, T3), at post-intervention (T4), and 3-month follow-up (T5).

Conditions

Emotional Disorders

Keywords

Dialectical Behavior Therapy Skills Training Group; Adolescents; Emotional Disorders

Outcome Measures

Primary Outcomes (4)

• Hamilton Depression Scale-17 item (HAMD-17)

  Hamilton Depression Scale-17 item (HAMD-17) is an outcome measure widely used in clinical. trials, with high score indicating a high degree of depression

  baseline, 5-month and 8-month follow-up

• Hamilton Anxiety Scale (HAM-A)

  Hamilton Anxiety Scale (HAM-A) comprises 14 items with each item being divided into five grades, based on a scale of 0 to 4. A high score indicates a high degree of anxiety.

  baseline, 5-month and 8-month follow-up

• Clinical Global Impressions-Severity (CGI-S)

  Clinical Global Impressions-Severity (CGI-S) is a standardized assessment tool used by clinicians to rate the severity of illness, change over time, and efficacy of medication.

  baseline, 5-month and 8-month follow-up

• Clinical Global Impressions-Improvement (CGI-I)

  Clinical Global Impression-Improvement (CGI-I), is also a 7-point scale that assesses how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

  baseline,5-month and 8-month follow-up

Study Arms (2)

Culturally adapted DBT-A-ST group

EXPERIMENTAL

The culturally adapted DBT-A-ST consists of 15 weekly group sessions, each lasting 120 minutes, including a 10-minute break. It maintains the core elements of standard DBT-A, including its philosophical foundation and treatment strategies. Therapists focus on teaching DBT skills through various methods such as modeling, structured behavioral rehearsals, and feedback. Each session begins with a 40-minute group mindfulness exercise and homework review, followed by 60 minutes dedicated to skill-specific didactics and experiential activities, concluding with a 10-minute homework assignment. Two group leaders facilitate the sessions, and participants track their skill usage daily with diary cards, which are reviewed weekly.

Behavioral: Culturally adapted DBT-A-ST group

Activities-based support group (ASG)

PLACEBO COMPARATOR

ASG, based on principles of client-centered supportive therapy, is widely used by occupational therapists in mental health settings. ASG therapists aim to foster a sense of belongingness, maintain unconditional positive regard, and provide empathy, psychoeducation, and a treatment structure. Two group leaders held the sessions; teaching DBT skills and using cognitive behavioral strategies are prohibited. Each session starts with a review of their experiences over the last week (30 min), a support-building activity (30 min), and ends with an open group discussion about topics participants choose each week (50 min). For homework, participants will be asked to think about issues discussed and to track daily social support on diary cards.

Behavioral: Activities-based support group (ASG)

Interventions

Culturally adapted DBT-A-ST group BEHAVIORAL

The culturally adapted DBT-A-ST consists of 15 weekly group sessions, each lasting 120 minutes, including a 10-minute break. It maintains the core elements of standard DBT-A, including its philosophical foundation and treatment strategies. Therapists focus on teaching DBT skills through various methods such as modeling, structured behavioral rehearsals, and feedback. Each session begins with a 40-minute group mindfulness exercise and homework review, followed by 60 minutes dedicated to skill-specific didactics and experiential activities, concluding with a 10-minute homework assignment. Two group leaders facilitate the sessions, and participants track their skill usage daily with diary cards, which are reviewed weekly.

Culturally adapted DBT-A-ST group

Activities-based support group (ASG) BEHAVIORAL

ASG, based on principles of client-centered supportive therapy, is widely used by occupational therapists in mental health settings. ASG therapists aim to foster a sense of belongingness, maintain unconditional positive regard, provide empathy, psychoeducational and a treatment structure. Two group leaders held the sessions, teaching DBT skills and using cognitive behavioral strategies are prohibited. Each session starts with a review of their experiences over the last week (30 min), a support-building activity (30 min), and ends with an open group discussion about topics participants choose each week (50 min). For homework, participants will be asked to think about issues discussed and to track daily social support on diary cards.

Activities-based support group (ASG)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age,
• informed consent is provided by the youth and one of the parents,
• Mandarin Chinese language proficiency sufficient to complete study questionnaire,
• a total score of either the PHQ-9≥ 10 or the GAD-7 ≥ 10,
• a current diagnosis of depressive or anxiety disorder from a K-SADS-E interview, including depression (F32-33); persistent mood disorder (F34), phobic anxiety disorder (F40), other anxiety disorder (F41), and adjustment disorders (F43.2).
• Individuals with comorbid diagnoses of several emotional disorders are also enrolled. Comorbidities will not be stratified because this will significantly increase the complexity of the design (i.e., some patients may have multiple comorbid diagnoses).

You may not qualify if:

• diagnoses of intellectual disability, schizophrenia, pervasive developmental disorder, anorexia nervosa and substance use disorder in the past 3 months,
• active suicidal ideation with a plan or a history of frequent or recent suicide risk in the past 3 months,
• ADHD without elevations in the areas of anxiety, depression, or stress problems on the CBCL,
• recent (past 4 weeks) change in psychiatric medication or unwillingness to maintain a stable dosage of medication during study participation,
• had received five or more sessions of CBT in the past or unwilling to stop concurrent psychotherapy,
• any mental or physical condition requiring hospital admission,
• severe medical condition.
• As we also aim for a naturalistic setting, we do not exclude patients who undergo medication changes during the trial if the treating clinician judges this to be necessary or clinically important.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (2)

MacKay Memorial Hospital

Taipei, Taiwan

ACTIVE NOT RECRUITING

MacKay Memorial Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Shen-Ing Liu, Ph.D

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Chun Huang, Ph.D

CONTACT

886-2-28094661; aihch@mmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Attending Psychiatrist, Professor

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 22, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)