Division of Mental Health and Addiction, Oslo University Hospital, P.O. Box 4959, 0424, Nydalen, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, P.O. Box 1171, 0318, Blindern, Oslo, Norway.
BMC Psychol. 2021 Jan 22;9(1):11. doi: 10.1186/s40359-021-00517-6.
Major depressive disorder (MDD) is a prevalent psychiatric condition associated with significant disability, mortality and economic burden. Cognitive behavioral therapy (CBT) and psychodynamic psychotherapy (PDT) are found to be equally effective for patients with depression. However, many patients do not respond sufficiently to either treatment. To offer individualized treatment, we need to know if some patients benefit more from one of the two therapies. At present little is known about what patient characteristics (moderators) may be associated with differential outcomes of CBT and PDT, and through what therapeutic processes and mechanisms (mediators) improvements occur in each therapy mode. Presently only theoretical assumptions, sparsely supported by research findings, describe what potentially moderates and mediates the treatment effects of CBT and PDT. The overall aim of this study is to examine theoretically derived putative moderators and mediators in CBT and PDT and strengthen the evidence base about for whom and how these treatments works in a representative sample of patients with MDD.
One hundred patients with a diagnosis of MDD will be randomized to either CBT or PDT. Patients will be treated over 28 weeks with either CBT (one weekly session over 16 weeks and three monthly booster sessions) or PDT (one weekly session over 28 weeks). The patients will be evaluated at baseline, during the course of therapy, at the end of therapy, and at follow-up investigations 1 and 3 years post treatment. A large range of patient and observer rated questionnaires (specific preselected putative moderators and mediators) are included.
The clinical outcome of this study may better guide clinicians when deciding what kind of treatment any individual patient should be offered. Moreover, the study aims to further our knowledge of what mechanisms lead to symptom improvement and increased psychosocial functioning.
ClinicalTrials.gov Identifier: NCT03022071.
重度抑郁症（MDD）是一种常见的精神疾病，与显著的残疾、死亡率和经济负担有关。认知行为疗法（CBT）和心理动力学心理治疗（PDT）被发现对抑郁症患者同样有效。然而，许多患者对两种治疗方法都没有足够的反应。为了提供个性化的治疗，我们需要知道是否有些患者从两种治疗方法中的一种中获益更多。目前，我们对哪些患者特征（调节剂）可能与 CBT 和 PDT 的不同结果相关，以及每种治疗模式通过什么治疗过程和机制（介质）发生改善知之甚少。目前，只有理论假设，很少有研究结果支持，描述了什么可能调节和介导 CBT 和 PDT 的治疗效果。本研究的总体目标是在 MDD 患者的代表性样本中，检查 CBT 和 PDT 中理论上推导的潜在调节剂和介质，并加强关于这些治疗方法对谁有效以及如何有效的证据基础。
100 名 MDD 诊断患者将被随机分配到 CBT 或 PDT 组。患者将接受 28 周的治疗，CBT 组（16 周每周一次，3 个月强化治疗 3 次）或 PDT 组（28 周每周一次）。患者将在基线、治疗过程中、治疗结束时以及治疗后 1 年和 3 年进行随访评估。包括大量患者和观察者评估问卷（特定预选的潜在调节剂和介质）。
该研究的临床结果可能会更好地指导临床医生在决定为任何个体患者提供哪种治疗方法时做出决策。此外，该研究旨在进一步了解导致症状改善和提高社会心理功能的机制。
ClinicalTrials.gov 标识符：NCT03022071。
