About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mandarin Chinese-language proficiency sufficient to complete the study questionnaire
A current diagnosis of depressive or anxiety disorder as diagnosed from a SCAN interview
Disqualifiers
Intellectual disability
Substance use disorder in the past three months
Bipolar disorder
Psychotic disorder
Trial design
Parallel
Treatments tested in this trial
Dialectical behavior therapy (DBT)
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
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.
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), with higher scores indicating a more severe panic attack.
Other outcomes
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.
List of threatening experiences (LTE)
The LTE questionnaire consists of 12 questions with dichotomous responses (i.e., yes/no) regarding the occurrence of 12 prevalent major stressful events.
Treatment History Interview -B (THI-B)
The THI-B is used to assess patients' experiences with the psychological treatments they received during the study.
Sponsors and contacts
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Mackay Memorial Hospital
Lead sponsor
National Science and Technology Council
Collaborator