跳至主要内容
临床试验/NCT05969080
NCT05969080招募中不适用

A Brief Intervention to Reduce Nonsuicidal Self-Injury and Improve Functioning in Veterans

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Feasibility as measured by number of participants enrolled

研究概览

简要总结

Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans.

详细描述

Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans. This treatment, known as the Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychoso ial functioning. A core component of T-SIB is functional assessment that identifies the antecedents and consequences of NSSI. This project will enhance T-SIB by using ecological momentary assessment (EMA) to conduct NSSI functional assessment in-vivo. EMA reduces retrospective recall bias and can increase engagement with therapeutic goals.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Past service in the United States military
  • Nonsuicidal self-injury engagement on 2 occasions in past 30 days
  • Fluent in English
  • Able to provide voluntary informed consent

排除标准

  • Lifetime history of psychosis, mania, or hypomania
  • Imminent risk for suicide/homicide warranting immediate intervention
  • Unable/unwilling to complete study procedures

研究组 & 干预措施

T-SIB

Experimental

Participants randomized to the Treatment for Self-Injurious Behaviors (T-SIB) condition will receive nine sessions of T-SIB.

干预措施: Treatment for Self-Injurious Behaviors (Behavioral)

Treatment As Usual

Active Comparator

Participants randomized to the TAU condition will be provided with referrals to both Durham VA and local community mental health resources and offered a consult for Durham VA mental health services.

干预措施: Treatment As Usual (Other)

结局指标

主要结局

Feasibility as measured by number of participants enrolled

时间窗: 2 years after study enrollment begins

All participants (N = 40) will need to be enrolled by the end of the second year of the study to consider the recruitment benchmark met.

Feasibility as measured rate of retention

时间窗: End of treatment, about nine weeks after beginning the study

Retention will be measured by the number of participants who complete at least six T-SIB treatment sessions. This benchmark will be considered meet if at least 2/3 of the 20 participants randomized to T-SIB complete at least 6 treatment sessions.

次要结局

  • Number of participants who report satisfaction with the T-SIB treatment(End of treatment, about nine weeks after beginning the study)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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