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临床试验/NCT05456035
NCT05456035招募中不适用

Social Cognitive Training to Enhance the Efficacy of CBT forDepression in Youth: A Developmental Approach (R33)

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年10月10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
82
试验地点
2
主要终点
Faux Pas Recognition Test

研究概览

简要总结

Depression in youth is a serious public health concern for which more personalized treatments are needed. This randomized controlled trial will test the effect of an intervention aimed at enhancing social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. Participants in the R33 (N=82) will be youth between ages 13- through 17-years-old currently experiencing depression. Youth will be randomized to either an enhanced CBT intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind (CBTSCT) as compared to CBT only. The primary target is improvement in both social cognitive skills and depressive symptoms at post-treatment and at a 6-month follow-up.

详细描述

Depression in adolescents is a recurrent and impairing disorder. Although some treatments have shown modest effects in children and adolescents (e.g., cognitive behavioral therapy - CBT), there remains a critical need to build upon these therapies to reach even more youths with depression. One variable hypothesized to affect children's interpersonal relationships is their level of social cognitive development on abilities particularly relevant to social functioning and CBT (e.g., social perspective taking; theory of mind). This RCT will test the efficacy of an intervention aimed at increasing children's social cognitive (SC) abilities. Adolescents (ages 13-17; N=82) with depression diagnoses or clinical levels of depressive symptoms (PHQ9 >15) will be randomized to either the social cognitive training enhanced CBT (CBTSCT) or CBT only. In the R33 RCT, investigators will conduct a trial aimed at replicating the results of the R61 with a new sample of 82 youth (ages 13-17) randomized to CBTSCT or CBT only. Youth will be evaluated regarding their social cognitive abilities (i.e., theory of mind), level of depressive symptoms, and social functioning at baseline, post-treatment, and at a 6-month follow-up. Finally, investigators will test if increases in social cognitive abilities partially accounted for the relation between treatment condition and decreases in depression. If the CBTSCT intervention significantly improves participants' social cognitive abilities and decreases depressive symptoms, then this will provide therapists with a more efficient and personalized treatment of depression in youth.

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
Single (Outcomes Assessor)

盲法说明

The individuals who conduct the assessments of the outcome measures will be unaware of to which condition the participant was randomized.

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

  • Participants ages 13- through 17-years-old
  • Youth must have a diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the Patient Health Questionnaire (PHQ9) > 15

排除标准

  • ever met criteria for a diagnosis of bipolar disorder, schizophrenia, autism, or conduct disorder
  • current alcohol or substance use disorder with significant impairment
  • imminent risk of suicide
  • reading level < 4th grade

结局指标

主要结局

Faux Pas Recognition Test

时间窗: after 12 weeks

Faux Pas Recognition test (FPRT) measures the ability to identify and explain faux pas situations where a character unintentionally insults another person due to lack of knowledge about some key feature of the other character. FPRT contains 8 Faux Pas and 8 control stories without a faux pas. Stories are followed by 8 questions. Higher scores mean better theory of mind.

Children's Depression Rating Scale-Revised

时间窗: after 12 weeks

In the R33 RCT, depression will be another primary outcome measured with the CDRS-R, which is a clinical interview with the parent and teen separately, about the youth's depressive symptoms during the last two weeks. Higher scores mean more depressive symptoms.

次要结局

未报告次要终点

研究者

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

Judith Garber

Professor of Psychology and Human Development

Vanderbilt University

研究点 (2)

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