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临床试验/NCT02060448
NCT02060448已完成不适用

Exploring Two Emotion-Focused Treatment Modules in Non-Suicidal Self-Injury

Boston University Charles River Campus2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013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
13
试验地点
2
主要终点
Frequency of non-suicidal self-injurious thoughts and behaviors

研究概览

简要总结

The overall aim of this study is to begin establishing an effective treatment for individuals who engage in non-suicidal self-injury (NSSI), as there are currently no evidence-based treatments that directly target this problematic behavior. Existing treatments that have demonstrated initial promise in reducing NSSI consist of many skills embedded in complex programs; therefore, the skill(s) responsible for improvements in NSSI are not clear. Procedures that focus on one's emotions, particularly that aim to increase emotional awareness and engagement in cognitive reappraisal (i.e., a way of thinking that lessens emotions), may be critical in effective NSSI treatment. The specific goals of this study are to investigate the effects of two specific emotion-focused treatment elements on NSSI. Participants will be ten individuals who meet the proposed Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5; American Psychiatric Association) criteria for NSSI disorder and engage in NSSI to reduce or escape from negative emotions. Two core modules of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011) will be adapted and delivered with the aim of reducing participants' non-suicidal self-injurious thoughts and behaviors. Each treatment module will consist of four 50-minute individual weekly sessions of emotion awareness training or cognitive reappraisal. The study will use a single-case experimental design, and phase change will be determined based on each participant's changes in non-suicidal self-injurious thoughts and behaviors.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years old
  • Engage in non-suicidal self-injury (NSSI) to reduce or lessen negative thoughts or feelings
  • Not taking psychotropic medications, or meet criteria for stability on a particular dose and are willing to maintain a stable dosage throughout the study
  • Meet the proposed Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for NSSI disorder, which includes:
  • five or more days in which the individual has engaged in NSSI in the past year
  • NSSI is associated with at least two two of the following: psychological precipitant (e.g., negative feelings or thoughts), urge prior to the act, preoccupation with NSSI, contingent response (e.g., expectation that the act will relieve a negative feeling state)
  • clinically significant distress or interference caused by NSSI or its consequences
  • NSSI does not occur exclusively during states of psychosis, delirium, or intoxication
  • absence of suicidal intent

排除标准

  • Current suicidal ideation and intent
  • Currently receiving cognitive-behavioral therapy (CBT) or any psychotherapy to address NSSI, anxiety, depression, or other Axis I disorders (and are not willing to discontinue that treatment)
  • Unwilling to refrain from initiating additional treatment during the course of the study
  • Current or very recent symptoms that warrant immediate clinical attention, alternative treatment, and/or a higher level of care that cannot be provided through the study (e.g., florid delusions or hallucinations, rapid mood state, severe manic symptoms)
  • Current or recent (within 3 months) history of substance use disorder (exception would be marijuana, caffeine, nicotine)
  • Emotional symptomatology is due to a medical/physical condition

结局指标

主要结局

Frequency of non-suicidal self-injurious thoughts and behaviors

时间窗: Daily (up to 126 days)

Frequency of non-suicidal self-injurious thoughts and behaviors will be indicated by participants' responses to electronic questions delivered through a smart phone daily, assessed up to 126 days.

次要结局

  • Deficits in Emotion Regulation Scale (DERS): Emotion Awareness and Nonacceptance of Negative Emotional Responses subscales(Weekly (up to 18 weeks))
  • Multi-dimensional Experiential Avoidance Questionnaire (MEAQ): Distraction/Suppression subscale(Weekly (up to 18 weeks))
  • Emotion Regulation Questionnaire (ERQ)(Weekly (up to 18 weeks))
  • Subjective Symptoms Scale (SSS)(Weekly (up to 18 weeks))
  • Southampton Mindfulness Questionnaire (SMQ)(Weekly (up to 18 weeks))
  • Beck Anxiety Inventory (BAI)(Weekly (up to 18 weeks))
  • Overall Anxiety Severity and Impairment Scale (OASIS)(Weekly (up to 18 weeks))
  • Overall Depression Severity and Impairment Scale (ODSIS)(Weekly (up to 18 weeks))
  • Beck Depression Inventory (BDI-II)(Weekly (up to 18 weeks))
  • Insomnia Severity Index (ISI)(Weekly (up to 18 weeks))

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kate H. Bentley

Doctoral Candidate

Boston University Charles River Campus

研究点 (2)

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