School of Human Health Sciences, University of Florence, Florence, Italy.
Center for Psychology and Health (Centro Di Psicologia e Psicoterapia), Tages Charity (Tages Onlus), Via Della Torretta 14, 50137, Florence, Italy.
BMC Psychiatry. 2023 Feb 20;23(1):113. doi: 10.1186/s12888-023-04610-5.
Schizotypal personality disorder is characterized by a pervasive pattern of maladaptive behavior that has been associated with the liability for schizophrenia. Little is known about effective psychosocial interventions. This pilot non-inferiority randomized controlled trial aimed to compare a novel form of psychotherapy tailored for this disorder and a combination of cognitive therapy and psychopharmacological treatment. The former treatment - namely, Evolutionary Systems Therapy for Schizotypy-integrated evolutionary, metacognitively oriented, and compassion focused approaches.
Thirty-three participants were assessed for eligibility, twenty-four randomized on a 1:1 ratio, nineteen included in the final analysis. The treatments lasted 6 months (24 sessions). The primary outcome was change across nine measurements in personality pathology, the secondary outcomes were remission from diagnosis and pre-post changes in general symptomatology and metacognition.
Primary outcome suggested a non-inferiority of the experimental treatment in respect to control condition. Secondary outcomes reported mixed results. There was no significant difference in terms of remission, but experimental treatment showed a larger reduction of general symptomatology (η = 0.558) and a larger increase in metacognition (η = 0.734).
This pilot study reported promising results about the effectiveness of the proposed novel approach. A confirmatory trial on large sample size is needed to provide evidence about relative effectiveness of the two treatment conditions.
ClinicalTrials.gov; NCT04764708; Registration day 21/02/2021.
分裂型人格障碍的特征是普遍存在适应不良的行为模式，与精神分裂症的易感性有关。目前对于有效的心理社会干预措施知之甚少。这项先导性非劣效随机对照试验旨在比较一种针对这种障碍的新型心理治疗方法和认知治疗与精神药理学治疗相结合的方法。前者的治疗方法——即整合了进化、元认知导向和同情心焦点的进化系统治疗——用于分裂型特质。
对 33 名参与者进行了资格评估，24 名参与者按 1:1 的比例随机分组，19 名参与者纳入最终分析。治疗持续 6 个月（24 次）。主要结局是人格病理学的 9 项测量指标的变化，次要结局是从诊断中缓解以及一般症状和元认知的前后变化。
主要结局表明，实验组在控制组的基础上具有非劣效性。次要结局报告了混合结果。在缓解方面没有显著差异，但实验组在一般症状学（η=0.558）和元认知（η=0.734）方面显示出更大的减少。
这项先导性研究报告了关于所提出的新型方法有效性的有希望的结果。需要进行更大样本量的验证性试验，以提供两种治疗条件相对有效性的证据。
ClinicalTrials.gov；NCT04764708；注册日期 2021 年 2 月 21 日。
