Evolutionary Systems Therapy for Early Onset of Personality Pathology: A Pilot Study on the Effectiveness and Feasibility With Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
Evolutionary Systems Therapy is a new form of therapy that has been previously tested in a randomized controlled trial and in a few cases of patients diagnosed with Cluster A personality disorders. The objective of the present study is to investigate the feasibility and preliminary efficacy of Evolutionary Systems Therapy in all forms of personality disorders. The study includes three project actions: (i) a case series on adolescents with personality disorders; (ii) a case series on young adults with personality disorders; (iii) an ecological momentary assessment study to confirm the conceptualization model on all the patients.
详细描述
To explore the feasibility and preliminary efficacy of Evolutionary Systems Therapy, the present study includes three actions. In the first action investigators enroll 6 adolescents (16-19 years) with personality disorders, in the second 15 young adults (20-25 years) with personality disorders. All participants receive 6 months of psychotherapy. The two subsamples of patients (adolescents and young adults) are assessed based on the conceptualization model of Evolutionary Systems Therapy which envisages three macro-organizations of personality (consistently with dimensional and hierarchical models such as Hierarchical Taxonomy of Psychopathology): internalizing, externalizing, schizotypal. Investigators plan to recruit patients until the size of the sub-samples is reached (15 young adults divided into 3 groups of 5 patients, each for each of the three interpersonal patterns; 6 adolescents divided into 3 groups of 2 patients, each for each of the three patterns interpersonal). In the third action, an ecological momentary assessment study will investigate the consistency over time between the conceptualization model and the experiences of the young adult patients enrolled: investigators will explore whether the hypothesized conceptualization will be confirmed by collected data on the patients' interpersonal styles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All data will be collected in a blinded manner by an assessor other than the therapists. Subsequently, the data will be anonymized and analyzed by a researcher from an institution different from the one in which the study takes place.
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with personality pathology in accordance with Structured Clinical Interview for DSM-5 - Alternative Model of Personality Disorders Module I
- •Being capable of read and sign the inform consent form
排除标准
- •Being diagnosed with schizophrenia spectrum disorders and other psychosis
- •Being diagnosed with bipolar disorders
- •Being diagnosed with autism spectrum disorder
- •Being diagnosed with intellectual disability
- •Being under any psychopharmacological or psychosocial treatment
结局指标
主要结局
Feasibility of the intervention
时间窗: 6 measurements: at the end of each of the six months of therapy
At least 70% rate of completion, adherence, therapeutic alliance and adverse events
Rate of individual change in personality pathology over time
时间窗: 9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy.
At least 75% rate of change in personality pathology over time as defined by a downward trend in mean of total score of Personality Inventory for DSM-5 Brief Form)
Group change in personality pathology over time
时间窗: 9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy.
Group change in personality pathology over time as defined by statistically significant change of sample mean of total score of Personality Inventory for DSM-5 Brief Form)
次要结局
- Differential effect of the intervention between interpersonal patterns(9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy.)
- Specific effect of the intervention between interpersonal patterns(40 measurements: 20 measurements in the month before surgery (2 measurements per day for the 10 days before the start of therapy) and 20 measurements in the month after surgery (2 measurements per day for the 10 days after the end of therapy))
- Remission from 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))