Recruiting NCT05989451

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

No phase Interventional Anxiety Disorder Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Dialectical behavior therapy (DBT).
Who it may be relevant to: Registry conditions: Anxiety Disorder, Depressive Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Taiwan
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders in Two Medical Centers: a Randomized Controlled Trial

Overview

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 15 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.

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 outcome measures

Change of total score of Hamilton Depression Scale-17 item (HAMD-17) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of Hamilton Anxiety Scale (HAM-A) [Time frame: 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) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]

Secondary outcome measures (12)

Change of total score of Depression, Anxiety, and Stress Scales (DASS-21) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of Patient Health Questionnaire-9 items (PHQ-9) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of Generalized Anxiety Disorder-7 items (GAD-7) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of Panic Disorder Severity Scale- Self Rating (PDSS-SR) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of Penn State Worry Questionnaire (PSWQ) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of Short Form Social Interaction Anxiety (SIAS) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of Short Form Social Phobia Scale (SPS) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of Difficulties in Emotional Regulation Scale (DERS) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of International Positive and Negative Affect Schedule-Short Form (PANAS-SF) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of The Work and Social Adjustment Scale (WSAS) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Change of total score of skills subscale (DSS) of the DBT Ways of Coping Checklist (DBT-WCCL) [Time frame: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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 was 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Treatment

Study locations

Taiwan · 1 center

MacKay Memorial Hospital — Taipei

Publications

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

Identifiers

NCT: NCT05989451 · 112-2314-B-195 -007 -MY3

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗