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临床试验/NCT03986125
NCT03986125已完成不适用

Emotional Awareness and Expression Therapy and Mindfulness Meditation Training for College Students With Anxiety and Somatic Symptoms: A Randomized Controlled Trial

Wayne State University2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2019年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Generalized Anxiety Scale-7

研究概览

简要总结

The present study is a randomized clinical trial of an emotional awareness and expression intervention (EAET) and a mindfulness meditation intervention (MMT) for Wayne State University students with anxiety and somatic symptoms. Each of these treatments will be compared to a wait list control condition and to one another to evaluate how well the treatments improve physical and psychological symptoms, stress, and interpersonal functioning of 120 Wayne State University students at 4-week and 8-weeks post-randomization. This research is intended to provide an evidence-based approach to working with emotions to improve both anxiety and somatic symptoms in young adults and will illuminate how EAET compares to the commonly used mindfulness training. It is hypothesized that both active interventions will be superior to no treatment, and differences between the two treatments will be explored.

详细描述

Anxiety is an increasingly common condition among college students and is often accompanied by somatic symptoms. These conditions impair students' social, psychological, and academic functioning and outcomes. Although students are utilizing campus and community mental health centers at increasing rates, these resources are strained. The present study aims to test the efficacy of two brief treatment options for students.

Integrating techniques from several emotion-focused therapies, the investigators have developed and tested an intervention encouraging the awareness and expression of habitually suppressed or avoided emotions. This Emotional Awareness and Expression Therapy (EAET) has been evaluated with various patient populations including fibromyalgia, irritable bowel syndrome, chronic pelvic pain, and medically unexplained symptoms. Results of these trials suggest that the intervention is efficacious in improving physical and psychological well-being, and is equal to or superior to other psychological interventions for somatic conditions. The present study seeks to advance the EAET literature by evaluating the efficacy of the intervention for a broader population and by employing a strong and conceptually different comparison condition: mindfulness meditation training.

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

盲法说明

Prior to randomization all parties will be blinded to experimental condition. Post treatment and follow up assessments will be conducted by a blinded research assistant.

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

  • university student, reporting at least moderate levels of anxiety (GAD-7) and somatic symptoms (PHQ-15) -

排除标准

  • psychosis, lack of fluency with spoken and written English language

结局指标

主要结局

Generalized Anxiety Scale-7

时间窗: change from baseline to four and eight weeks after baseline

symptoms of anxiety

Patient Health Questionnaire-15

时间窗: change from baseline to four and eight weeks after baseline

The 15-item measure asks patients how much they have been bothered by various somatic symptoms such as headaches, back pain, and digestive distress during the previous 2 weeks, with answers ranging from 0 (not at all) to 2 (a lot). Items are summed to generate a total score with higher scores indicating greater distress regarding somatic symptoms.

次要结局

  • Brief Symptom Inventory(change from baseline to four and eight weeks after baseline)
  • Patient Global Impression of Change(four and eight weeks after baseline)
  • Satisfaction With Life Scale(change from baseline to four and eight weeks after baseline)
  • Perceived Stress Scale(change from baseline to four and eight weeks after baseline)

研究者

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

Mark A. Lumley

Distinguished Professor

Wayne State University

研究点 (2)

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