Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05989451
Other study ID # 112-2314-B-195 -007 -MY3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date October 2026

Study information

Verified date February 2024
Source Mackay Memorial Hospital
Contact Hui-Chun Huang, Ph.D
Phone 886-2-28094661
Email aihch@mmh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date October 2026
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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 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.

Locations

Country Name City State
Taiwan MacKay Memorial Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
Mackay Memorial Hospital National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Change of diagnosis of Schedules for Clinical Assessment in Neuropsychiatry (SCAN) Schedules for Clinical Assessment in Neuropsychiatry (SCAN), a semi-structured clinical interview with high reliability, is used to assess Axis I disorders. Diagnoses are assigned a clinical severity rating with a score of 0 (no symptoms attaining clinically significant severity) to 4 (severe interfering or disturbing in daily activity) as the clinical threshold for diagnostic criteria. at baseline, at 20 weeks, at 32 week
Primary 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
Primary 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
Primary 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 Change of total score of Depression, Anxiety, and Stress Scales (DASS-21) DASS-21 is a self-report measure of depression, anxiety and stress. Each seven-item scale has four response options ranging from 0 (do not apply to me at all) to 3 (apply to me much, or most of the time). Higher scores on each scale indicate higher depression, anxiety, and distress. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of Patient Health Questionnaire-9 items (PHQ-9) PHQ-9 is a nine-item self-rated questionnaire to measure the severity of depressive symptoms corresponding to the DSM-V criteria of MDD. Each item of the PHQ-9 requires a response on a 4-point scale, ranging from 0 (never) to 3 (nearly everyday), for a total score ranging from 0 to 27, with higher scores indicating increased likelihood for major depressive disorder. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of Generalized Anxiety Disorder-7 items (GAD-7) GAD-7 is a seven-item self-rated questionnaire to assess the severity of generalized anxiety disorder according to DSM-IV diagnostic criteria. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of Panic Disorder Severity Scale- Self Rating (PDSS-SR) PDSS-SR is a self-reported instrument to rate the overall severity of panic disorder. It consists of 7 items coded on a 5-point ordinal scale (0-4), in which higher scores indicate a more severe panic attack. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of Penn State Worry Questionnaire (PSWQ) PSWQ has been widely used as a self-report measure of worry and GAD in most treatment outcome studies of GAD. It has 16 items and each item is rated on a scale from 1 ('not at all typical of me') to 5 ('very typical of me'). Total score indicate greater levels of pathological worry. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of Short Form Social Interaction Anxiety (SIAS) The Social Interaction Anxiety Scale (SIAS) is companion measures developed for social anxiety. It is among the most commonly used tool for assessing social anxiety and the outcome of psychosocial therapy. Short-form SIAS is the self-report scale with items rated on a 5-point Likert-type scale with values ranging from 0 "Not at all characteristic or true of me" to 4 "Extremely characteristic or true of me". Higher scores indicate more severe social anxiety. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of Short Form Social Phobia Scale (SPS) The Social Phobia Scale (SPS) is companion measures developed for social anxiety. It is among the most commonly used tool for assessing social anxiety and the outcome of psychosocial therapy. Short-form SPS is the self-report scale with items rated on a 5-point Likert-type scale with values ranging from 0 "Not at all characteristic or true of me" to 4 "Extremely characteristic or true of me". Higher scores indicate more severe social anxiety. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of Difficulties in Emotional Regulation Scale (DERS) DERS including 36 items which assess difficulties regulating emotion across six domains, will be used to assess emotional dysregulation. Items are rated on a scale of 1 ("almost never ") to 5 ("almost always"). Higher scores indicate more difficulty in emotion regulation. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of International Positive and Negative Affect Schedule-Short Form (PANAS-SF) The 10-item I-PANAS-SF includes five items measuring positive affect (PA) and five items measuring negative affect (NA). Responses were provided on a 5-point Likert scale ranging from 1 (never) to 5 (always). The higher scores on both PA and NA items indicate the tendency to experience a positive and negative mood. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF) It evaluates overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications. Items are rated on a 5-point scale ('not at all or never' to 'frequently or all the time'), which higher scores indicate better enjoyment and satisfaction with life. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of The Work and Social Adjustment Scale (WSAS) WSAS was developed to measure the functional impairment resulting from a health problem. Each item is rated on a 9-point Likert scale from 0 (no impairment) to 8 (very severe impaired). Total scores range from 0 to 40; scores of <10 indicate a subclinical condition, 10 to 20 significant functional impairment but less severe clinical symptomatology, and =20 moderately severe psychopathology. at baseline, at 20 weeks, at 32 week
Secondary Change of total score of skills subscale (DSS) of the DBT Ways of Coping Checklist (DBT-WCCL) DBT Skills Subscale (DSS; 38 items), which assesses adaptive coping responses. Participants rate how often they have used each strategy in the past month using a 4-point Likert-type scale from 0 (never used) to 3 (regularly used).Higher scores indicate more frequent use of these skills. at baseline, at 20 weeks, at 32 week
See also
  Status Clinical Trial Phase
Completed NCT01316926 - Paxil CR Bioequivalence Study Brazil Phase 1
Recruiting NCT06187454 - Transcranial Direct Current Stimulation for Depression N/A
Completed NCT04469322 - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression N/A
Recruiting NCT05768126 - Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine Phase 4
Completed NCT03219879 - Telephone-administered Relapse Prevention for Depression N/A
Recruiting NCT06038721 - Unified Protocol: Community Connections N/A
Completed NCT03043560 - Study to Treat Major Depressive Disorder With a New Medication Phase 2
Completed NCT04091139 - Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong Phase 2/Phase 3
Completed NCT00069459 - Seasonal Affective Depression (SAD) Study Phase 1
Recruiting NCT05503966 - Combining Antidepressants and Attention Bias Modification in Depression N/A
Recruiting NCT03001245 - Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents N/A
Completed NCT02939560 - TMS for Adults With Autism and Depression N/A
Completed NCT02542891 - European Comparative Effectiveness Research on Internet-based Depression Treatment N/A
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Completed NCT02306551 - Well Being And Resilience: Mechanisms of Transmission of Health and Risk
Withdrawn NCT02238730 - Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy N/A
Completed NCT02224508 - Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks N/A
Completed NCT01597661 - Bupropion & Cardio Birth Defect (Slone) N/A
Completed NCT01407575 - Buprenorphine for Treatment Resistant Depression Phase 3
Completed NCT01093053 - Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations N/A