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临床试验/NCT00468013
NCT00468013已完成不适用

A Computer-Based Intervention for Medically Unexplained Physical Symptoms

University of Medicine and Dentistry of New Jersey1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年3月1日最近更新:
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
60
试验地点
1
主要终点
Positive and Negative Affect Scale

研究概览

简要总结

In this study 60 people with medically unexplained physical symptoms (MUPS) will receive either a 6-session resilience skill building intervention provided fully online or a weekly computerized journaling assignment. Both programs can be completed from home. Participants will complete questionnaires both before and after the intervention and changes in symptoms, mood and satisfaction with life will be assessed.

详细描述

SUBJECTS: Sixty patients between the ages of 18 and 80 will be recruited from primary care clinics affiliated with the University of Medicine and Dentistry of New Jersey - Robert Wood Johnson Medical School (UMDNJ-RWJMS). Qualified patients will be primary care patients who meet the following inclusion and exclusion criteria: Patients between the ages of 18 and 75 seeking medical care for physical symptoms (i.e., persistent fatigue, pain complaints, and gastrointestinal, cardiovascular or musculoskeletal symptoms). No major medical illness to explain symptom(s) is found after detailed physical and laboratory assessment. Patients with common disorders such as hypertension, asthma, diabetes, low back strain, etc., will be included if in the opinion of the physician the presenting physical symptoms are not due to the underlying disorder. In order to enter the study, patients must meet criteria for at least 4 medically unexplained symptoms out of the 42 somatic symptoms listed in the Composite International Diagnostic Interview (CIDI) rated as currently present if males and at least 6 symptoms if females (Escobar's abridged criteria). Patients without ready access to a computer and the Internet will be excluded from participating. Also excluded will be individuals with life threatening medical illness, communicative disorder, lack of fluency in English, illiteracy, and major psychiatric conditions including psychoses, bipolar disorder, and alcohol or drug abuse. Patients will be required to add no medications to their regimen during the study period (approximately 6 weeks).

BASELINE ASSESSMENT. After reading and signing the informed consent, all participants will complete a baseline assessment consisting of questionnaires and a measure delivered by structured interview. Questionnaires will include the Health Assessment Questionnaire (HAQ), Quick Inventory of Depressive Symptomatology (QIDS), the PRIME-MD Somatic Symptoms Scale only (SSS), Positive and Negative Affect Scale (PANAS), Satisfaction with Life Scale (SWLS), and a demographics questionnaire. The structured interview will consist of the Composite International Diagnostic Interview (CIDI).

PROCEDURES: Subjects will be randomized to one of two groups. The psychological resilience building group's exercises will be posted on a state-of-the-art website known as "Authentic Happiness". Participants will be provided with the web address and shown how to access the site and the Research Portal where the 6 exercises that are the focus in this and other ongoing studies can be found. The journaling group will be instructed to write weekly for 60-minutes about how they used or plan to use their time over slightly varying time frames: 1) over the previous 24 hours, 2) over the previous week, 3) over the previous year, 4) in the next 24 hours, 5) in the next week and 6) in the next year. The journaling participants will use "PowerJournal". PowerJournal 0.2 for Windows is a downloadable program; once downloaded and installed on the computer, there is no further need for an Internet connection. This is a simple word-processing program, similar in style to Microsoft Word.

FOLLOW UP ASSESSMENT. After the intervention is complete, participants will be sent the same questionnaires (plus the Follow-Up Form) as used in the pre-intervention battery by mail and asked to return the questionnaires in the self-addressed, stamped envelope included. We estimate that these questionnaires will take about 30 minutes to complete. This will concluded their participation in the study.

研究设计

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

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
否

入选标准

  • •Qualified patients will be primary care patients who meet the following inclusion and

排除标准

  • •Patients between the ages of 18 and 75 seeking medical care for physical symptoms (i.e., persistent fatigue, pain complaints, and gastrointestinal, cardiovascular or musculoskeletal symptoms). No major medical illness to explain symptom(s) is found after detailed physical and laboratory assessment. Patients with common disorders such as hypertension, asthma, diabetes, low back strain, etc., will be included if in the opinion of the physician the presenting physical symptoms are not due to the underlying disorder. In order to enter the study, patients must meet criteria for at least 4 medically unexplained symptoms out of the 42 somatic symptoms listed in the Composite International Diagnostic Interview (CIDI) rated as currently present if males and at least 6 symptoms if females (Escobar's abridged criteria).
  • •Exclusion Criteria:
  • •Patients without ready access to a computer and the Internet will be excluded from participating. Also excluded will be individuals with life threatening medical illness, communicative disorder, lack of fluency in English, illiteracy, and major psychiatric conditions including psychoses, bipolar disorder, and alcohol or drug abuse. Patients will be required to add no medications to their regimen during the study period (approximately 6 weeks).

研究组 & 干预措施

1

Experimental

Computer-based exercises to be executed at home.

干预措施: Resilience Building Exercises (Behavioral)

2

Sham Comparator

Computer-based exercises to be executed at home.

干预措施: Journaling (Behavioral)

结局指标

主要结局

Positive and Negative Affect Scale

时间窗: Baseline and 6 weeks

Satisfaction with Life Scale

时间窗: Baseline and 6 weeks

Quick Inventory of Depressive Symptoms

时间窗: Baseline and 6 weeks

次要结局

  • Patient Health Questionnaire(Baseline and 6 weeks)
  • Health Assessment Questionnaire(Baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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