跳至主要内容
临床试验/NCT06577675
NCT06577675招募中不适用

Progression of a Group of Patients Suffering From Emotional Dysregulation But Heterogeneous in Terms of Diagnosis, Benefiting From the DBT Group Programme.

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
2
主要终点
DERS (Difficulties in Emotion Regulation Scale)

研究概览

简要总结

Human beings experience emotions and have the ability to manage them, but when these abilities are undermined by mental illness, the result is emotional dysregulation. Borderline patients (1 to 4% of the population) suffer from this symptom and can benefit from a specific therapy: DBT (Dialectical Behaviour Therapy; Linehan, 1993). Created specifically for this condition, DBT significantly reduces emotional dysregulation, a dimension at the root of behavioural disorders that is known to be poorly relieved by drug treatments. The DBT group training programme offers patients the opportunity to learn and practise emotional regulation skills. Four types of skills are taught skills: mindfulness, interpersonal skills, emotional regulation and and distress tolerance. This therapy is part of the psychiatric care, in which patients take responsibility in their own care.

There are many studies showing the effectiveness of DBT and its programme with borderline patients. But there are other pathologies concerned by emotional dysregulation: thymic disorders in particular bipolar (1 to 2.5%), addictive disorders (8 to 10%), eating disorders (ADD, 10%), post-traumatic stress disorder (PTSD, 2%).

详细描述

A few other studies have demonstrated the efficacy of DBT in patients suffering from other psychiatric disorders (antisocial personality, addictive disorders, particularly alcohol, eating disorders). However, no study has attempted to test the impact of DBT on emotional regulation in a diagnostically heterogeneous group of patients.

The investigators therefore propose, for the first time, to group together different pathologies in the field of emotional regulation disorders (borderline disorders, thymic disorders including bipolarity, anxiety disorders including PTSD, addictive disorders, eating disorders) in order to study the specific influence of the DBT programme on these emotional dysfunctions as its main objective.

The aim of this study is to describe the evolution of a group of diagnostically heterogeneous patients (Borderline Disorder, Bipolar Disorder, Addictive Disorders, CAT Disorders, PTSD) suffering from emotional dysregulation, benefiting from the DBT group programme, in a reduced version of this therapy, since it will take place over 4 to 5 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

入选标准

  • Patients affiliated to or entitled under a social security scheme
  • Patients aged 18 to 65 suffering from emotional dysregulation and presenting one of the following clinical profiles: borderline disorder, bipolar disorder, addictive disorders, eating disorders, PTSD.
  • Follow-up by the Saint Etienne sector (mobile teams, psychological medical centre, intra-hospital services, full-time therapeutic reception centre and day hospitals).
  • DERS scale score >
  • Patient having received informed information about the study and having signed consent to participate in the study.

排除标准

  • Psychotic disorders,
  • Melancholic depression,
  • Aggressive and hostile behaviour preventing group work,
  • Intellectual deficit,
  • Patient under guardianship.

结局指标

主要结局

DERS (Difficulties in Emotion Regulation Scale)

时间窗: Weeks 1, 7, 12 and 16

Measures six dimensions of emotion regulation. The 36 items are scored on a 5-point Likert scale. The score is between 36 and 180, 36 for no emotional difficulty and 180 for maximum emotional dysregulation. The higher the score, the greater the difficulty the subject has in emotion regulation.

次要结局

  • Quality of life measured by the World Health Organization Quality of Life (WHOQOL-BREF)(Weeks 1 and 16.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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