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临床试验/NCT02151500
NCT02151500已完成不适用

Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms

Wayne State University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Symptom Interpretation Questionnaire (SIQ)

研究概览

简要总结

The goal of this study is to test the feasibility and acceptability of providing an experiential assessment interview that targets emotional and stressful experiences in primary care. In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The investigators hypothesize that helping individuals first identify the links between their stress and symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotions is likely to influence their physical symptoms and psychological status.

详细描述

Emotional stress, particularly when a patients inhibits their experiences and feelings, contributes to physical symptoms. However, primary care patients with medically unexplained symptoms are rarely assessed for the stress and emotions in an comprehensive manner. The goal of this study is to test the feasibility and acceptability of providing an experiential assessment interview that targets emotional and stressful experiences in primary care with medically unexplained physical symptoms. In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The interview will review patients health history, psychosocial history, make links between the two, and help patients identify and express emotions related to conflicts or victimization. The investigators hypothesize that helping individuals first identify the links between their stress and symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotions is likely to influence their physical symptoms and psychological status.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must score above 10 (moderate range) on the Patient Health Questionnaire-15, which is a measure of a range of medical symptoms that are often medically unexplained.

排除标准

  • Conditions that could interfere with the interview:
  • non-English speaking
  • psychosis
  • mental impairment
  • The presence of disease or injury that could account for the physical symptoms. - Examples: autoimmune disease, bodily injury, serious infection, cancer, heart disease, COPD, post-stroke.

结局指标

主要结局

Symptom Interpretation Questionnaire (SIQ)

时间窗: Change from baseline symptom attribution at 6-weeks

次要结局

  • Brief Pain Inventory (BPI)(Change from baseline pain at 6-weeks)
  • Brief Fatigue Inventory(Change from baseline fatigue at 6-weeks)
  • Emotional Processing Scale (EPS)(Change from baseline emotional processing at 6-weeks)
  • Change Assessment Questionnaire(Changes from baseline stage of change at 6-weeks)
  • Pain Catastrophizing Scale (PCS)(Change from baseline pain catastrophizing at 6-weeks)
  • Patient Health Questionnaire-15 (PHQ-15)(Change from baseline in symptom severity at 6-weeks)
  • Emotional Approach Coping Scale (EAC)(Change from baseline emotional approach coping at 6-weeks)
  • Inventory of Interpersonal Problems Scale (IIP-32)(Change from baseline interpersonal problems at 6-weeks)
  • Brief Symptom Inventory (BSI)(Change from baseline symptoms at 6-weeks)
  • Satisfaction with Life Scale (SWLS)(Change from baseline life satisfaction at 6-weeks)
  • Insomnia Severity Scale (ISI)(Change from baseline insomnia at 6-weeks)
  • McGill Pain Questionnaire (SF-MPQ-2)(Change from baseline pain at 6-weeks)

研究者

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

Mark A. Lumley

Professor

Wayne State University

研究点 (2)

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