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临床试验/NCT02406625
NCT02406625已完成不适用

Clinical and Neural Changes Associated With Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors

Fundacion Clinic per a la Recerca Biomédica2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
2
主要终点
Neural changes after 16 sessions of Dialectical Behavioral Therapy.

研究概览

简要总结

Suicidal behaviors among adolescents represents a public health problem due to its high prevalence and its low predictability. It is also known that brain development continues during adolescence, therefore, a therapeutic intervention during this period might propitiate neural changes that might favor the emotional regulation involved in suicidal behaviors. Dialectical Behavioral Therapy has proved to be effective regarding this problem.

For this reason, the investigators aimed to study the clinical, neuropsychological and neural effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.

详细描述

Suicidal behaviors represent a public health problem due to its high prevalence and its low predictability. At a neurological level, higher vulnerability for suicidal behavior has been related to a frontostriatal-cingulum tract dysfunction as well as attention, memory and executive deficits. It is also known that brain development continues during adolescence, therefore, a therapeutic intervention during this period might propitiate neural changes that could favor the emotional regulation involved in suicidal behaviors. Specifically, Dialectical Behavioral Therapy has proved to be effective regarding this problem.

The investigators hypothesis is that DBT (Dialectical Behavioral Therapy) will improve clinical symptoms associated with suicidal behaviors, as well as the neural interconnections, which will result not only in structural and functional connectivity changes, but also in a better cognitive functioning. The investigators aimed to investigate the clinical, neuropsychological, and neural effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.

The investigators method is a randomized, controlled study that includes 30 patients with suicidal behaviors and 15 healthy controls between the ages of 12 and 18 years. Patients were assigned to one of two groups (randomized): DBT and Regular Support Therapy. Clinical and neuropsychological evaluations were performed before and after the treatment for both patient groups. Additionally, Structural MRI data sets, diffusion-tensor imaging (DTI) and Functional Connectivity (Resting State fmri) were acquired for all patients and controls at baseline and after treatment. Initial characteristics will be compared between the three groups, and the investigators will also compared clinical, neuropsychological and imaging measures before and after the treatment.

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
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 12 and 18 years,
  • Intellectual level over 70 (IQ>70)
  • For the experimental groups:
  • Patients with suicidal behavior:
  • Real attempt,
  • Interrupted attempt,
  • Aborted attempt or behaviors, or
  • Preparation actions (based on the Columbia Suicide Severity Rating Scale -C-SSRS criteria) present during the last 12 months and that persist in the actual moment.

排除标准

  • Presence of Acute Psychosis,
  • Eating Disorder with an BMI < 18.5;
  • Substance abuse in the current moment or during the last 6 months;
  • Any neurological condition that curses with cognitive alterations; and
  • Pregnancy.

结局指标

主要结局

Neural changes after 16 sessions of Dialectical Behavioral Therapy.

时间窗: 4 months

Magnetic Resonance Imaging and functional Magnetic Resonance Imaging data sets will be acquired at baseline and then after the treatment, in order to determine anatomical or functional brain connectivity changes in relation to the applied therapy.

Clinical changes after 16 sessions of Dialectical Behavioral Therapy.

时间窗: 4 months

Clinical evaluations will be performed before and after the treatment in order to determine clinical improvement in relation to the applied therapy.

Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy.

时间窗: 4 months

Neuropsychological evaluations will be administrated before and after the treatment in order to determine changes in memory, attention or executive functioning in relation to the applied therapy.

次要结局

未报告次要终点

研究者

发起方
Fundacion Clinic per a la Recerca Biomédica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marisol Picado Rossi

Ph.D.

Fundacion Clinic per a la Recerca Biomédica

研究点 (2)

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