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

NCT ID: NCT05989451

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-10-31

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.

Detailed Description

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. This 3-year intervention trial has a randomized, controlled, two-center, and single-blinded design with two parallel groups. The trial will be conducted in the psychiatry departments of two medical centers, employing identical protocols. Participants will be recruited and randomly allocated 1:1 to one of two study arms. The modified DBT protocol in an individual therapy format consists of 12 weekly individual sessions, each lasting 50 minutes. A minimum of 250 participants will be included based on sample size estimation. Assessments will take place before the start of the trial, at the end of the trial, and at a 3-month follow-up. Primary outcomes will be the severity of depression and anxiety, rated by blind assessors. Secondary outcomes include disorder-specific symptoms, disorder severity, functional impairment, quality of life, and emotion regulation biases. The investigators will also examine the treatment mechanisms and treatment processes.

Conditions

Anxiety Disorder; Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment as Usual (TAU)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Transdiagnostic Adapted DBT plus TAU

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.

Group Type: EXPERIMENTAL

Dialectical behavior therapy (DBT)

Intervention Type: 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.

Interventions

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 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Mandarin Chinese-language proficiency sufficient to complete 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council

FED

Sponsor Role: collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shen-Ing,Liu

Senior Visiting Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shen-Ing Liu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

MacKay Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hui-Chun Huang, Ph.D

Role: CONTACT

aihch@mmh.org.tw

886-2-28094661 ext. 3055

Facility Contacts

Hui-Chun Huang, Ph.D

Role: primary

aihch@mmh.org.tw

886228094661 ext. 3055

References

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.

Reference Type: DERIVED

PMID: 39506661 (View on PubMed)

Other Identifiers

112-2314-B-195 -007 -MY3

Identifier Type: -

Identifier Source: org_study_id