Clinical trial NCT05989451: Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders
Official title: Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders in Two Medical Centers: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorder
Depressive Disorder
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2023-08-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of total score of Hamilton Depression Scale-17 item (HAMD-17)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Hamilton Anxiety Scale (HAM-A)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)
timeFrame: at baseline, at 20 weeks, at 32 week
Secondary outcomes:
measure: Change of total score of Depression, Anxiety, and Stress Scales (DASS-21)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Patient Health Questionnaire-9 items (PHQ-9)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Generalized Anxiety Disorder-7 items (GAD-7)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Panic Disorder Severity Scale- Self Rating (PDSS-SR)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Penn State Worry Questionnaire (PSWQ)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Short Form Social Interaction Anxiety (SIAS)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Short Form Social Phobia Scale (SPS)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Difficulties in Emotional Regulation Scale (DERS)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of International Positive and Negative Affect Schedule-Short Form (PANAS-SF)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of The Work and Social Adjustment Scale (WSAS)
timeFrame: at baseline, at 20 weeks, at 32 week
measure: Change of total score of skills subscale (DSS) of the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: at baseline, at 20 weeks, at 32 week
Other outcomes:
measure: Change of diagnosis of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
timeFrame: at baseline, at 20 weeks, at 32 week
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: