跳至主要内容
临床试验/NCT02129790
NCT02129790已完成不适用

Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Self-harm Scores

研究概览

简要总结

Children and adolescents with early-onset bipolar disorder (BD) are at high risk for intentionally hurting themselves. Although there are therapies in existence for these youths with BD, they do not address suicide prevention specifically. Mentalization-based therapy for adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and adult population with borderline personality disorder. The investigators will modify the MBT-A treatment procedures for persons with BD who have had a recent period of suicidal ideation or behavior.

详细描述

Youth with early-onset bipolar disorder (BD) are at an elevated risk for intentional self-harm compared to healthy adolescents or adolescents with other psychiatric disorders. Adolescents vulnerable to emotion dysregulation and self-harm often have deficits in the ability to mentalize: to understand, acknowledge, and predict thoughts and feelings in oneself and others. Mentalization-based therapy for adolescents (MBT-A) has been shown to be more effective than 'usual care' in reducing self-harm for adolescents and adults with borderline personality disorder. MBT-A includes psychoeducational and coping strategies that may prove quite effective for bipolar adolescents who are at elevated risk for self-harm.

Participation in this study will last 9 months. All participants will receive a thorough medical-psychiatric evaluation. All youth will be able to receive pharmacotherapy with a study psychiatrist in the CHAMP clinic. The MBT-A will consist of up to 21 weekly, biweekly and monthly individual sessions interspersed with 9 monthly family sessions (30 therapy hours total). Participants will also complete follow-up assessments every 3 months for 9 months. These assessments will include research interviews and questionnaires.

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 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Bipolar Disorder I, Bipolar Disorder II, or Bipolar Disorder Not Otherwise Specified
  • Living with or in close contact with at least one parent who is willing to participate
  • Have had at least 1 week in the prior 3 months of significant suicidal ideation and/or at least one suicidal event in the 3 months prior to study intake.
  • Willing to be treated pharmacologically by a psychiatrist in the UCLA Child and Adolescent Mood Disorders (CHAMP) clinic

排除标准

  • Participants requiring immediate hospitalization
  • Diagnosis of borderline personality disorder, schizophrenia, or schizoaffective disorder.
  • Current substance dependence disorder

研究组 & 干预措施

Mentalization-Based Therapy

Experimental

Up to 21 individual MBT-A sessions plus 9 monthly family sessions. MBT-A will include psychoeducation and coping strategies.

干预措施: Mentalization-Based Therapy (Behavioral)

结局指标

主要结局

Self-harm Scores

时间窗: measured every 3 months for 9 months

Self-harm is a composite score derived from two Kiddie Schedule for Affective Disorders and Schizophrenia Depression Rating Scale items, total scores on the Harkavy-Asnis Suicide Scale, total scores on the Risk and Self-Harm Scale, and specific levels of ideation or behavior on the Columbia Suicide and Self-Harm Scale.

次要结局

  • Depression scores(every 3 months for 9 months)
  • Treatment completion(first 6 study months)

研究者

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

David J. Miklowitz, Ph.D.

Professor of Psychiatry

University of California, Los Angeles

研究点 (2)

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