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

NCT05989451 | Recruiting

• 1 other identifier: 112-2314-B-195 -007 -MY3
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorder; Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• Change of total score of Hamilton Depression Scale-17 item (HAMD-17)

  Hamilton Depression Scale-17 item is an interview-based instrument for rating the overall levels of severity of the symptoms of depression and the response to treatment. Each item is rated from 0 to 4 or 0 to 2; the scores correspond to increases in severity. Total scores range from 0 to 52.

  at baseline, at 20 weeks, at 32 week

• Change of total score of Hamilton Anxiety Scale (HAM-A)

  HAM-A comprises 14 items with each item being divided into five grades, based on a scale of 0 to 4, with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  at baseline, at 20 weeks, at 32 week

• Change of total score of Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)

  CGI-S (severity): the current condition of the patient on a scale of 1-7 (1 being normal, and 7 being among the most severely ill patients). CGI-I (improvement): the degree of improvement, as perceived by the clinician, since the start of treatment of a scale of 1-7, 1 being very much improved, and 7 being very much worse.

  at baseline, at 20 weeks, at 32 week

Secondary Outcomes (12)

• Change of total score of Depression, Anxiety, and Stress Scales (DASS-21)

  at baseline, at 20 weeks, at 32 week

• Change of total score of Patient Health Questionnaire-9 items (PHQ-9)

  at baseline, at 20 weeks, at 32 week

• Change of total score of Generalized Anxiety Disorder-7 items (GAD-7)

  at baseline, at 20 weeks, at 32 week

• Change of total score of Panic Disorder Severity Scale- Self Rating (PDSS-SR)

  at baseline, at 20 weeks, at 32 week

• Change of total score of Penn State Worry Questionnaire (PSWQ)

  at baseline, at 20 weeks, at 32 week

Other Outcomes (1)

• Change of diagnosis of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)

  at baseline, at 20 weeks, at 32 week

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

Treatment-as-usual (TAU) is a naturalistic treatment condition as delivered in current daily practice by psychiatrists in the medical services in Taiwan. TAU typically includes prescription and monitoring of antidepressant and/or anxiolytic medication, psychological treatment (this may include empathic listening and/or supportive counselling, psychoeducation, etc), or a combination of both. Patients in the TAU condition already receiving any of the aforementioned treatments are informed they will continue to receive as usual the services received before enrollment in the study.

Transdiagnostic Adapted DBT plus TAU

EXPERIMENTAL

The modified DBT protocol, developed by the principal investigator and co-investigators, which will be offered in an individual therapy format. It consists of 12 weekly individual sessions, each lasting 50-60 minutes. It is made based on the manual (Linehan 2015), retaining the essence of DBT (Linehan 1993), and remain dialectically focused. Each session focuses on specific skills within that content of modules.

Behavioral: Dialectical behavior therapy (DBT)

Interventions

Dialectical behavior therapy (DBT) BEHAVIORAL

The modified DBT protocol, developed by the principal investigator and co-investigators, will be offered in an individual therapy format. It consists of 12 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.

Transdiagnostic Adapted DBT plus TAU

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mandarin Chinese-language proficiency sufficient to complete study questionnaire
• A current diagnosis of depressive or anxiety disorder as diagnosed from a SCAN interview

You may not qualify if:

• Intellectual disability
• Substance use disorder in the past three months
• Bipolar disorder
• Psychotic disorder
• Organic brain disorder
• Acute suicidality or a history of frequent or recent suicide attempts
• Recent (past six 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 five years or unwilling to stop concurrent psychotherapy for an emotional disorder
• Any mental or physical condition requiring hospital admission
• Another medical condition likely to prevent participation in the study

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• National Science and Technology Council: collaborator

Study Sites (1)

MacKay Memorial Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• Liu SI, Chang CH, Lin CJ, Chen SC, Huang HC, Lin Y, Chang YH, Yeh HM, Lin IC, Wu SI. Modified dialectical behavior therapy-informed transdiagnostic intervention for emotional disorders: protocol for a randomized controlled trial. BMC Psychiatry. 2024 Nov 6;24(1):771. doi: 10.1186/s12888-024-06069-4.

  PMID: 39506661 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

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: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Visiting Staff

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)