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临床试验/NCT02326012
NCT02326012已完成不适用

Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Deliberate Self-Harm Inventory - 9 item version

研究概览

简要总结

The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy for Adolescents (ERITA) who self-harm.

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
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • a primary diagnosis of NSSI as defined by DSM-5 Section 3
  • < 1 NSSI episode during the past month
  • at least one parent needs to commit to participate in the parent program

排除标准

  • bipolar disorder I or primary psychosis
  • severe suicidal ideation
  • ongoing substance dependence
  • Insertion/withdrawal of psychopharmacological substances within two months prior to the treatment
  • other acute primary axis I diagnosis (e.g. anorexia nervosa) that demand treatment in first hand
  • current life circumstances that would hinder the treatment (i.e. ongoing domestic abuse)
  • insufficient Swedish language skills
  • Cocurrent treatment with Mentalization based therapy (MBT) or Dialectical behavioral therapy (DBT)

结局指标

主要结局

Deliberate Self-Harm Inventory - 9 item version

时间窗: Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up

Change from baseline in self-harming behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.

次要结局

  • Evaluation of the Drug Use Disorders Identification Test - C (DUDIT-C)(Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up)
  • Borderline Symptom List Behavior supplement (BSL-supplement)(Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up)
  • Difficulties in Emotion Regulation Scale -16 item version (DERS-16)(Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up)
  • Diary questionnaire (DQ)(Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up)
  • Difficulties in Emotion Regulation Scale (DERS)(Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up)
  • Strengths and Difficulties Questionnaire Child and Parent version (SDQ-C/P)(Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up)
  • Borderline personality features in childhood (BPFS-C)(Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up)
  • The alcohol use disorders identification test - C (AUDIT-C)(Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Clara Hellner Gumpert

PhD

Karolinska Institutet

研究点 (2)

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