A Confirmatory Randomized Controlled Trial Comparing Evolutionary Systems Therapy for Schizotypal Personality Disorder With Cognitive Behavioral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in general symptomatology
研究概览
简要总结
This study aims at replicating existing preliminary evidence about the effectiveness of Evolutionary Systems Therapy for Schizotypy (ESTS). The present randomized controlled trial (RCT) will compare ESTS with Cognitive Behavioral Therapy (CBT) in treating Schizotypal Personality Disorder (SPD). The main questions our RCT aims to answer are:
- Is ESTS more effective than CBT in treating SPD?
- Is ESTS more feasible than CBT in treating SPD?
38 patients diagnosed with SPD will be recruited and randomly allocated to either the experimental group (i.e. ESTS) or the control group (CBT). Primary outcome will be reduction in general symptomatology, whereas secondary outcomes will be changes in target mechanisms (self-criticism and metacognition) and remission from diagnosis.
详细描述
A previous study suggested how ESTS (experimental group; EG) may be not inferior in respect to a combine treatment comprising of CBT and psychopharmacological treatment (control group; CG). Despite the encouraging results, it has been suggested that the presence in the CG of a mandatory pharmacological treatment would have represented a bias. Indeed, a few partecipants refused pharmacological treatment.
Thus, the investigators outlined an RCT aimed at comparing the two interventions (ESTS and CBT) without any mandatory pharmacological treatment. Moreover, the investigators consider the need for a pharmacological treatment during the study as an exclusion criterion.
The investigators expect to extend our knowledge about the feasbility and effectiveness of ESTS for those diagnosed with SPD:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
An experienced first clinician will make the initial assessment without knowing the assignment to the two groups. Similarly, a second expert clinician will evaluate the participants at the end of th.e intervention without knowing the assignment to the two groups. The data will then be anonymized and a statistician will analyze them without knowing which group corresponds to which treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Schizotypal Personality Disorder at SCID-5-AMPD Module III
- •Age 18 or older
- •Being capable of reading and signing the inform consent form in Italian
- •Being capable of attending a talk therapy in Italian
排除标准
- •Being diagnosed with schizophrenia spectrum disorders or other psychosis disorder
- •Being diagnosed with neurodevelopmental or neurological disorders
- •Being diagnosed with bipolar disorder
- •Being under any psychological or pharmacological treatment
结局指标
主要结局
Change in general symptomatology
时间窗: 2 measurements: one at baseline assessment; one at final assessment
Change in the total score of Symptom Checklist-90-R (SCL-90-R) between two measurements
次要结局
- Change in metacognition(2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions))
- Change in critical beliefs about others(2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions))
- Change in schizotypal traits 2(2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions))
- Change in critical beliefs about self(2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions))
- Change in schizotypal traits 1(2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions))
- Change in remission from primary diagnosis(2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions))