跳至主要内容
临床试验/NCT04211688
NCT04211688已完成不适用

Real-world Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder: A Pragmatic Randomized Clinical Trial

Consorci Sanitari del Maresme0 个研究点目标入组 80 人开始时间: 2017年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
主要终点
BPD (borderline personality disorder) symptomatology

研究概览

简要总结

Background and Objectives: Schema therapy has been shown to be of benefit in treating borderline personality disorder. However, it is still unclear what the most suitable treatment implementation format is and to what extent therapeutic gains may be generalizable to regular healthcare settings with limited resources.

Methods: A pragmatic randomized controlled trial was conducted ona representative Spanish sample of outpatients with a DSM-5 main diagnosis of borderline personality disorder. Patients were allocated either to a combined (group plus individual) schema therapy format (n=40) or to a group-only schema therapy format (n=40). Borderline personality disorder severity was the primary outcome, with other clinical variables considered as secondary outcomes (e.g., early maladaptive schemas, functioning). The assessment protocol included baseline, post-treatment (after 12months of treatment), and six-month follow-up evaluations. Data was analyzed through a two-way repeated measures ANOVA. Limitations were a limited follow-up assessment and the absence of multi-center data that detracted from the long-term stability and generalizability of the findings.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •DSM-5 criteria for borderline personality disorder
  • •Aged 18 to 65 years

排除标准

  • •Psychotic disorders (except short, reactive psychotic episodes)
  • •Bipolar disorder (current hypo-manic or mixed episode)
  • •Antisocial personality disorder
  • •Substance intoxication
  • •Mental retardation

研究组 & 干预措施

Combined individual + group Schema therapy

Experimental

Those who will receive both individual plus group schema therapy

干预措施: Group Schema therapy (Behavioral)

Combined individual + group Schema therapy

Experimental

Those who will receive both individual plus group schema therapy

干预措施: Individual Schema therapy (Behavioral)

Only group Schema therapy

Active Comparator

Those who will receive group schema therapy

干预措施: Group Schema therapy (Behavioral)

结局指标

主要结局

BPD (borderline personality disorder) symptomatology

时间窗: 18 months

Severity of borderline symptomatology as measured by a single score from the BSL-23 scale (range: 0-92; the higher the score, the more severe the BPD severity).

次要结局

  • early maladaptive schemas(18 months)
  • global functioning(18 months)

研究者

发起方
Consorci Sanitari del Maresme
申办方类型
Other
责任方
Sponsor

相似试验