Effect sizes of psychotherapies currently stagnate at a low‐to‐moderate level. Personalizing psychotherapy by algorithm‐based modular procedures promises improved outcomes, greater flexibility, and a better fit between research and practice. However, evidence for the feasibility and efficacy of modular‐based psychotherapy, using a personalized treatment algorithm, is lacking. This proof‐of‐concept randomized controlled trial was conducted in 70 adult outpatients with a primary DSM‐5 diagnosis of major depressive disorder, a score higher than 18 on the 24‐item Hamilton Rating Scale for Depression (HRSD‐24), at least one comorbid psychiatric diagnosis according to the Structured Clinical Interview for DSM‐5 (SCID‐5), a history of at least “moderate to severe” childhood maltreatment on at least one domain of the Childhood Trauma Questionnaire (CTQ), and exceeding the cut‐off value on at least one of three measures of early trauma‐related transdiagnostic mechanisms: the Rejection Sensitivity Questionnaire (RSQ), the Interpersonal Reactivity Index (IRI), and the Difficulties in Emotion Regulation Scale‐16 (DERS‐16). Patients were randomized to 20 sessions of either standard cognitive‐behavioral therapy alone (CBT) or CBT plus transdiagnostic modules according to a mechanism‐based treatment algorithm (MoBa), over 16 weeks. We aimed to assess the feasibility of MoBa, and to compare MoBa vs. CBT with respect to participants’ and therapists’ overall satisfaction and ratings of therapeutic alliance (using the Working Alliance Inventory ‐ Short Revised, WAI‐SR), efficacy, impact on early trauma‐related transdiagnostic mechanisms, and safety. The primary outcome for efficacy was the HRSD‐24 score at post‐treatment. Secondary outcomes included, among others, the rate of response (defined as a reduction of the HRSD‐24 score by at least 50% from baseline and a score <16 at post‐treatment), the rate of remission (defined as a HRSD‐24 score ≤8 at post‐treatment), and improvements in early trauma‐related mechanisms of social threat response, hyperarousal, and social processes/empathy. We found no difficulties in the selection of the transdiagnostic modules in the individual patients, applying the above‐mentioned cut‐offs, and in the implementation of MoBa. Both participants and therapists reported higher overall satisfaction and had higher WAI‐SR ratings with MoBa than CBT. Both approaches led to major reductions of depressive symptoms at post‐treatment, with a non‐significant superiority of MoBa over CBT. Patients randomized to MoBa were nearly three times as likely to experience remission at the end of therapy (29.4% vs. 11.4%; odds ratio, OR = 3.2, 95% CI: 0.9‐11.6). Among mechanism‐based outcomes, MoBa patients showed a significantly higher post‐treatment effect on social processes/empathy (p<0.05) compared to CBT patients, who presented an exacerbation on this domain at post‐treatment. Substantially less adverse events were reported for MoBa compared to CBT. These results suggest the feasibility and acceptability of an algorithm‐based modular psychotherapy complementing CBT in depressed patients with psychiatric comorbidities and early trauma. While initial evidence of efficacy was observed, potential clinical advantages and interindividual heterogeneity in treatment outcomes will have to be investigated in fully powered confirmation trials.

中文翻译：

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针对抑郁症、精神合并症和早期创伤患者的基于算法的模块化心理治疗与认知行为治疗：一项概念验证随机对照试验

心理治疗的效果目前停滞在低至中等水平。通过基于算法的模块化程序进行个性化心理治疗有望改善结果、更大的灵活性以及研究与实践之间的更好契合。然而，缺乏使用个性化治疗算法的基于模块化的心理治疗的可行性和有效性的证据。这项概念验证随机对照试验在 70 名成年门诊患者中进行，这些患者经 DSM-5 初步诊断为重度抑郁症，且 24 项汉密尔顿抑郁量表 (HRSD-24) 得分至少高于 18 分根据 DSM-5 结构化临床访谈 (SCID-5) 诊断出一种共病精神疾病，在儿童创伤问卷 (CTQ) 的至少一个领域有至少“中度至重度”儿童虐待史，并且超过削减标准早期创伤相关跨诊断机制的三项测量中至少一项的偏离值：拒绝敏感性问卷（RSQ）、人际反应指数（IRI）和情绪调节困难量表‐16（DERS‐16）。根据基于机制的治疗算法 (MoBa)，患者被随机接受 20 次单独标准认知行为治疗 (CBT) 或 CBT 加跨诊断模块治疗，为期 16 周。我们的目的是评估 MoBa 的可行性，并比较 MoBa 与 CBT 的参与者和治疗师的总体满意度和治疗联盟评级（使用工作联盟清单 - 简短修订版，WAI-SR）、疗效、对治疗的影响。早期创伤相关的跨诊断机制和安全性。疗效的主要结局是治疗后的 HRSD-24 评分。次要结局包括缓解率（定义为 HRSD-24 评分较基线降低至少 50%，且治疗后评分<16）、缓解率（定义为 HRSD-24 评分24 治疗后得分≤8），以及社会威胁反应、过度唤醒和社会过程/同理心等早期创伤相关机制的改善。我们发现在个体患者中选择转诊断模块、应用上述截止值以及 MoBa 的实施没有困难。与 CBT 相比，参与者和治疗师都表示 MoBa 的总体满意度更高，WAI-SR 评级也更高。这两种方法都导致治疗后抑郁症状大幅减轻，MoBa 相对于 CBT 没有显着优势。随机接受 MoBa 的患者在治疗结束时获得缓解的可能性几乎是其三倍（29.4% vs. 11.4%；比值比，OR = 3.2，95% CI：0.9‐11.6）。在基于机制的结果中，与 CBT 患者相比，MoBa 患者在社会过程/同理心方面表现出显着更高的治疗后效果（p<0.05），CBT 患者在治疗后该领域表现出恶化。与 CBT 相比，MoBa 报告的不良事件明显减少。这些结果表明，基于算法的模块化心理疗法补充 CBT 对于患有精神共病和早期创伤的抑郁症患者的可行性和可接受性。虽然观察到了初步疗效证据，但治疗结果的潜在临床优势和个体间异质性必须在充分有力的确认试验中进行研究。