跳至主要内容
临床试验/NCT05734677
NCT05734677招募中不适用

Emotion Regulation Group Intervention for Late Adolescents: a Clinical Trial

Camille Nemitz Piguet2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
56
试验地点
2
主要终点
Changes from Baseline in Difficulties in emotion regulation scale (DERS)

研究概览

简要总结

A clinical trial to evaluate the effects of an eight-week emotion regulation group intervention designed for adolescents (16-20 years old) on the levels of emotion dysregulation both self-reported by the adolescent and reported by his/her parent/caregiver (pre-post comparison). The long-term effect will also be measured at a third-time point, three months after the end of the intervention. The intervention will consist of 90-minute sessions once a week for 8 weeks, in groups of eight participants. The intervention proposed for this study is an adaptation from different interventions already in use for adolescents in clinical practice, such as Dialectical Behavior Therapy (DBT), Mentalization-Based Treatment (MBT) and Mindfulness-Based Intervention (MBI).

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

入排标准

年龄范围
16 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 16 to 20 years old.
  • > 4 criteria of borderline symptoms (out of the 9 listed in the DSM-5) including emotional liability
  • French speaking
  • Availability during the whole study
  • Willingness in participating to the intervention and the research
  • Informed consent read and signed

排除标准

  • Current hospitalization
  • Psychotic disorder
  • Severe and persistent substance addiction
  • Antisocial personality disorder
  • Inability to participate in group sessions
  • Current pregnancy
  • Non-French speaking
  • Previous enrolment into the current study

结局指标

主要结局

Changes from Baseline in Difficulties in emotion regulation scale (DERS)

时间窗: V3 (3 months after the intervention)

36 items self-report scale: Higher scores suggest greater problems with emotion regulation.

Changes from Baseline in Emotion Dysregulation Inventory (EDI)

时间窗: V3 (3 months after the intervention)

Informant-report measure of emotion dysregulation

次要结局

  • Changes from Baseline in parent-report Family Attitude Scale (FAS)(V3 (3 months after the intervention))
  • Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)(V3 (3 months after the intervention))
  • Changes from Baseline in Beck Depression Inventory (BDI-II)(V3 (3 months after the intervention))
  • Changes from Baseline in State-Trait Anxiety Inventory (STAI)(V3 (3 months after the intervention))
  • Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)(V3 (3 months after the intervention))
  • Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)(V3 (3 months after the intervention))
  • Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)(V3 (3 months after the intervention))
  • Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)(V3 (3 months after the intervention))
  • Changes from Baseline in Borderline Symptom List (BSL-23)(V3 (3 months after the intervention))
  • Changes from Baseline in self-report Family Attitude Scale (FAS)(V3 (3 months after the intervention))

研究者

发起方
Camille Nemitz Piguet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Camille Nemitz Piguet

MD, PhD, PD

University of Geneva, Switzerland

研究点 (2)

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