Clinical trial NCT06566235: Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders
Official title: Cultural Adaptation and Implementation of Dialectical Behavior Therapy Skills Training Group for Adolescents With Emotional Disorders: a Feasibility Study and a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotional Disorders
Keywords: Dialectical Behavior Therapy Skills Training Group
Adolescents
Emotional Disorders
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: A randomized controlled trial will be conducted in a medical center's child adolescent psychiatry department. Participants aged 12-17 years with current depressive or anxiety disorders as diagnosed using the K-SADS-E will be recruited and randomly allocated 1:1 to one of two study arms: a) culturally adapted DBT-A-ST group, b) Activities-based support group. Both interventions are in group format and include 15 weekly sessions, 120 min/each session. Based on power calculation, a target sample size of 160 youths will be included. Assessments will occur before the trial starts, at the 4th and 8th treatment sessions, in the end, and at the 3-month follow-up.

Primary outcomes are the severity of depression and anxiety, rated by blind assessors. Secondary outcomes include general psychopathology, number of DSM-5 disorders, quality of life, and self-reported measures. The treatment mechanisms and implementation processes will also be examined.

Eligibility criteria: Inclusion Criteria:

* 12-17 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hamilton Depression Scale-17 item (HAMD-17)
timeFrame: baseline, 5-month and 8-month follow-up
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: baseline, 5-month and 8-month follow-up
measure: Clinical Global Impressions-Severity (CGI-S)
timeFrame: baseline, 5-month and 8-month follow-up
measure: Clinical Global Impressions-Improvement (CGI-I)
timeFrame: baseline,5-month and 8-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Shen-Ing Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: