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Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders

ClinicalTrials.gov IDNCT05989451

PhaseNA

Enrollment250

SponsorMackay Memorial Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Anxiety Disorder, Depressive Disorder

About this study

Anxiety and depressive disorders, referred to as emotional disorders, have high rates of prevalence, recurrence, and functional impairment. Transdiagnostic psychotherapy targeting shared features of these disorders has recently emerged. Dialectical behavior therapy (DBT) for the transdiagnostic treatment of emotional disorders is a promising approach, as results of preliminary studies for use in a broad range of mental disorders are encouraging. Since there is a lack of research on transdiagnostic psychotherapy in Taiwan, the investigators thus propose this 3-year randomized controlled trial to test the efficacy of a modified DBT for the treatment of transdiagnostic emotional disorders and to further evaluate whether the efficacy of modified DBT differs in the specific emotional disorders. The investigators expect that patients with emotional disorders receiving modified DBT are more likely to improve clinical outcomes, functioning, and quality of life.

Interventions

Behavioral: Dialectical behavior therapy (DBT) — The modified DBT protocol, developed by the principal investigator and co-investigators, will be offered in an individual therapy format. It consists of 15 weekly individual sessions, each lasting 50-60 minutes. It is made based on the manual, retaining the essence of DBT and remaining dialectically focused. Each session focuses on specific skills within the context of modules.

Primary outcomes

Change of total score of Hamilton Depression Scale-17 item (HAMD-17) (Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks))
Change of total score of Hamilton Anxiety Scale (HAM-A) (Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks))
Change of total score of Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I) (Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks))

Eligibility information

Inclusion Criteria: 1. Mandarin Chinese-language proficiency sufficient to complete the study questionnaire 2. A current diagnosis of depressive or anxiety disorder as diagnosed from a SCAN interview Exclusion Criteria: 1. Intellectual disability 2. Substance use disorder in the past three months 3. Bipolar disorder 4. Psychotic disorder 5. Organic brain disorder 6. Acute suicidality or a history of frequent or recent suicide attempts 7. Recent (past six weeks) change in psychiatric medication or unwillingness to maintain a stable dosage of medication during study participation 8. Had received five or more sessions of CBT in the past five years or was unwilling to stop concurrent psychotherapy for an emotional disorder 9. Any mental or physical condition requiring hospital admission 10. Another medical condition likely to prevent participation in the study As we also aim for a naturalistic setting, we do not exclude patients who undergo a medication change during the trial if this is judged necessary or clinically important by the treating clinician. Instead, we include a question about this in the questionnaire to the referring/treating clinician.

Study locations

MacKay Memorial Hospital, Taipei, Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.