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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMackay Memorial Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dialectical behavior therapy (DBT)

    Behavioral

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Treatment as Usual (TAU)No intervention 0 interventions
Group B: Transdiagnostic Adapted DBT plus TAUExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
2

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.

Time frame
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
3

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.

Time frame
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)

Secondary outcomes

1

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.

Time frame
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
2

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.

Time frame
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
3

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.

Time frame
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
4

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.

Time frame
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)

Other outcomes

1

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.

Time frame
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
2

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.

Time frame
Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)
3

Treatment History Interview -B (THI-B)

The THI-B is used to assess patients' experiences with the psychological treatments they received during the study.

Time frame
Posttreatment (20 weeks)

Sponsors and contacts

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Mackay Memorial Hospital

Lead sponsor

National Science and Technology Council

Collaborator