Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Dialectical behavior therapy (DBT).
- Кому может быть актуально
- Состояния в реестре: Anxiety Disorder, Depressive Disorder. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders in Two Medical Centers: a Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое 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.
Первичные конечные точки
- Change of total score of Hamilton Depression Scale-17 item (HAMD-17) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
- Change of total score of Hamilton Anxiety Scale (HAM-A) [Срок оценки: 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) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Вторичные конечные точки (12)
- Change of total score of Depression, Anxiety, and Stress Scales (DASS-21) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
- Change of total score of Patient Health Questionnaire-9 items (PHQ-9) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
- Change of total score of Generalized Anxiety Disorder-7 items (GAD-7) [Срок оценки: 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) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
- Change of total score of Penn State Worry Questionnaire (PSWQ) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
- Change of total score of Short Form Social Interaction Anxiety (SIAS) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
- Change of total score of Short Form Social Phobia Scale (SPS) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
- Change of total score of Difficulties in Emotional Regulation Scale (DERS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
- Change of total score of The Work and Social Adjustment Scale (WSAS) [Срок оценки: 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) [Срок оценки: Pretreatment (0 weeks), Posttreatment (20 weeks), 12-week follow-up (32 weeks)]
Критерии участия
Критерии включения
- Mandarin Chinese-language proficiency sufficient to complete the study questionnaire
- A current diagnosis of depressive or anxiety disorder as diagnosed from a SCAN interview
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Тайвань · 1 центр
- MacKay Memorial Hospital — Taipei
Публикации
- 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
Идентификаторы
NCT: NCT05989451 · 112-2314-B-195 -007 -MY3