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临床试验/NCT01941862
NCT01941862已完成不适用

Development and Evaluation of a Brief, Suicide Prevention Intervention Targeting Anxiety and Mood Vulnerabilities

Florida State University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Interpersonal Needs Questionnaire (INQ)

研究概览

简要总结

The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.

详细描述

DARTS is a newly developed computerized treatment targeting specific risk factors associated with suicide, mood, and anxiety symptoms. Eligible individuals will be randomized to one of several conditions. In all conditions, participants will complete various self-report questionnaires and a neurophysiology assessment that involves an EEG. Some participants will also be asked to complete four additional EEG assessments. In addition, all participants will be asked to complete a 1, 3, and 6-month follow-up appointment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At or above community sample mean on ASI-3
  • At or above community sample mean on INQ-R
  • English speakers
  • 18 years of age or older

排除标准

  • Significant medical illness
  • Current substance dependence
  • Current or past psychotic-spectrum disorders
  • Uncontrolled bipolar disorder
  • Serious suicidal intent that warranted immediate treatment

研究组 & 干预措施

Combined Risk Reduction

Experimental

The combined intervention will involve all of the interventions in the anxiety and mood risk reduction conditions and thus will not be matched for length.

干预措施: Psychoeducation and Cognitive Bias Modification (Behavioral)

Anxiety Risk Reduction

Experimental

The anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced.

干预措施: Psychoeducation and Cognitive Bias Modification (Behavioral)

Mood Risk Reduction

Experimental

The mood risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for perceived burdensomeness and thwarted belongingness. The psychoeducational component will focus on dispelling myths related to burdensomeness and belongingness and describe their role in the development of mood symptoms.

干预措施: Psychoeducation and Cognitive Bias Modification (Behavioral)

Repeated Contact Control

No Intervention

Participants assigned to the repeated contact group will be assigned a "personal" study coordinator. The coordinator will contact them at specific intervals during the study. The rationale for these contacts will be provided (e.g., checking in on their status and helping to administer some brief measures). During the three weeks (corresponding to treatment session intervals for those in one of the active treatment conditions), the study coordinator will contact the participant once per week for a brief phone check in where suicide risk will be evaluated. Participants in the control group will also meet with their study coordinator during each of the scheduled follow-up visits.

结局指标

主要结局

Interpersonal Needs Questionnaire (INQ)

时间窗: Month 6 follow-up

The INQ is a 15-item self-report measure of the constructs of thwarted belongingness and perceived burdensomeness as defined by the Interpersonal Theory of Suicide. Van Orden et al. report high internal consistency coefficients for the thwarted belongingness (α=.85) and perceived burdensomeness subscales (α=.89). In support of construct validity, both subscales were found to prospectively predict suicidal ideation.

次要结局

  • Anxiety Sensitivity Index-3 (ASI-3)(Month 6 follow-up)

研究者

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

Norman Schmidt

Professor

Florida State University

研究点 (2)

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