Department of Medicine, Mackay Medical College, No.46, Sec. 3, Zhongzheng Rd., Sanzhi Dist., New Taipei City, 252005, Taiwan.
Department of Psychiatry, Mackay Memorial Hospital, Taipei, Taiwan.
BMC Psychiatry. 2024 Nov 6;24(1):771. doi: 10.1186/s12888-024-06069-4.
Anxiety and depressive disorders, characterized by high incidence and functional impairments, are emotional disorders with shared etiological and maintenance mechanisms. Dialectical behavior therapy (DBT) is a promising approach for the transdiagnostic treatment of emotional disorders. Developing a brief DBT intervention can facilitate the adoption of evidence-based therapy.
This protocol is for a 3-year single-blinded, two-arm randomized controlled trial. Individuals with depressive or anxiety disorder will be randomly allocated to a modified DBT-informed transdiagnostic psychotherapy group or a treatment-as-usual group. The intervention group will receive DBT individual therapy for 15 weeks. Power analyses revealed that the cohort should include a minimum of 250 participants. Preintervention, postintervention, and follow-up (after 3 months) assessments will be conducted. Primary outcomes will be severities of depression and anxiety rated by blind assessors. Intent-to-treat and per-protocol analyses will be conducted using the hierarchical linear model. Effect sizes will be estimated using Cohen's d.
To the best of our knowledge, the proposed study will be the first randomized controlled trial to evaluate the efficacy of a modified DBT intervention in managing transdiagnostic emotional disorders in Chinese individuals.
This intervention is expected to improve clinical outcomes, daily functioning, and quality of life. The trial will enrich the empirical evidence for transdiagnostic interventions, facilitating the implementation of evidence-based therapy and reducing the high prevalence and challenges (e.g., disability) of emotional disorders in the Chinese population.
NCT05989451.
焦虑和抑郁障碍的发病率高且功能受损，具有共同的病因和维持机制，属于情绪障碍。辩证行为疗法（DBT）是一种有前途的情绪障碍共病治疗方法。开发一种简短的 DBT 干预措施可以促进基于证据的治疗方法的采用。
这是一项为期 3 年的单盲、双臂随机对照试验的方案。将抑郁或焦虑障碍患者随机分配到改良的 DBT 知情的共病心理治疗组或常规治疗组。干预组将接受 15 周的 DBT 个体治疗。功效分析显示，该队列应至少包括 250 名参与者。在干预前、干预后和随访（3 个月后）进行评估。主要结局指标将由盲法评估者评定的抑郁和焦虑严重程度。将使用分层线性模型进行意向治疗和符合方案分析。使用 Cohen's d 估计效应大小。
据我们所知，该研究将是第一项评估改良 DBT 干预对中国人群共病情绪障碍管理效果的随机对照试验。
该干预措施有望改善临床结局、日常功能和生活质量。该试验将丰富共病干预的实证证据，促进基于证据的治疗方法的实施，并减少中国人群中情绪障碍的高患病率和挑战（例如残疾）。
NCT05989451。
