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临床试验/NCT01018433
NCT01018433已完成1 期

Development of an Intervention for Non-Suicidal Self-Injury in Young Adults

Fordham University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
45
试验地点
2
主要终点
NSSI frequency and severity

研究概览

简要总结

The purpose of this study is to investigate an intervention specifically for non-suicidal self-injury (NSSI) in young adults. The goal of this 9-session outpatient intervention is to reduce the frequency and severity of NSSI. During Phase I, 12 patients will be treated in an open pilot trial. During Phase II, 60 patients will be treated in a randomized controlled pilot study in order to determine the feasibility and acceptability of the intervention and to investigate change in NSSI frequency and severity over time.

详细描述

Non-suicidal self-injury (NSSI), deliberate harm to the body without suicidal intent, is highly prevalent in young adults, with 1 in 10 college students engaging in over 100 episodes in their lifetimes. Consequences of NSSI are severe, including physical injury ranging in medical severity, distress from shame associated with the behavior, social isolation, psychological symptoms, and increased risk and lethality of NSSI over time. Despite the prevalence and significant consequences of NSSI, no empirically supported treatments specific to NSSI exist. The purpose of this study is to develop, implement, and evaluate an intervention specifically for NSSI in young adults, the Treatment for Self-Injurious Behaviors (T-SIB). This time-limited intervention will integrate theoretically-based strategies whose utility has been identified through empirical research with the goal of reducing frequency and severity of NSSI. The research plan consists of 2 phases. During Phase 1, 12 patients will be treated in an open pilot trial. During Phase 2, 60 patients will be treated in a randomized controlled pilot study to determine the feasibility and acceptability of T-SIB, investigate change in NSSI frequency and severity between T-SIB and treatment as usual (TAU) through a 3-month follow up period, and evaluate the research design of the randomized controlled pilot study to inform both the utility and design of a larger randomized clinical trial.

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)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18-29
  • NSSI within the past month OR history of NSSI and urge to self-injure within the past month

排除标准

  • Psychotic symptoms
  • Severe suicidal ideation

结局指标

主要结局

NSSI frequency and severity

时间窗: Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up

次要结局

  • BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA(Baseline, Post-Intervention, 3 month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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