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临床试验/NCT01453647
NCT01453647已完成不适用

Self-Efficacy, Stress, Immunity and Symptoms of Fibromyalgia

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2010年1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
72
试验地点
1
主要终点
Fatigue

研究概览

简要总结

This project will be the first known to explore the relationships among immunity and stress and the symptoms of fatigue, pain, and mood following guided imagery in women with fibromyalgia. Finding ways to reduce these unpleasant symptoms may lead to improved function and well-being in this chronic disorder.

详细描述

Fibromyalgia (FM) is a chronic widespread pain and fatigue syndrome that affects 3 to 6 million adults in the United States. Consequences of FM include physical and psychological distress, loss of work productivity, reduced quality of life, and increased use of health resources. Although the mechanisms underlying the symptomatology of FM are not clear; one theory suggests potential alterations in cytokine balance. Because the symptoms of FM may be worsened by stress and negative psychological processes, mind-body modalities may positively influence the neuroendocrine and immunological mediators of symptoms in FM. Given that immune modulation by both psychosocial stressors and interventions has been linked to health changes, self-efficacy (i.e., the belief that one can cope), may be one mechanism affecting FM outcomes. The specific aims of this project are: (1) to test the effects of a 10-week guided imagery intervention in comparison to an attention control group among women diagnosed with fibromyalgia on (a) the primary outcomes of self-efficacy for managing symptoms and perceived stress and (b) the secondary outcomes of symptoms of fatigue, pain, distressed mood, and depressive symptoms and markers of immune function; and (2) to examine the relationships among self-efficacy for managing symptoms, perceived stress, symptoms of fatigue, pain, distressed mood, and depressive symptoms and markers of immune function. The biobehavioral framework to guide this project is adapted from psychoneuroimmunology. Using a randomized controlled two-group design with repeated measures, 72 individuals will be recruited and randomized into one of two groups: Usual Care plus guided imagery (GI) intervention (Group 1) or Usual Care alone (i.e., attention control group) (Group 2). The intervention consists of three 30-minute guided imagery audio recordings to be used in a proscribed manner over a 10-week period. An ANCOVA model will be used to test for group differences between the intervention and standard care groups at week 10. This project will be the first known to explore the relationships among cytokines and perceived stress and the symptoms of fatigue, pain and mood following the administration of a biobehavioral intervention in women with FM.

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
Female
接受健康志愿者
否

入选标准

  • •ages 18 and older
  • •diagnosis of FM based on the American College of Rheumatology criteria and documented by the patient's primary physician
  • •no known major psychiatric or neurological conditions that would interfere with project participation
  • •able to speak and read standard English
  • •a minimum of a 6th grade education level
  • •an ability to understand and sign the consent form and understand and complete the pencil and paper assignments

排除标准

  • •presence of other systemic rheumatologic conditions such as rheumatoid arthritis, systemic lupus erythematosus, and/or Sjogren's Disease
  • •history of epilepsy
  • •any present psychiatric disorder involving a history of psychosis (e.g., schizophrenia, schizoaffective disorder; schizophreniform disorder, delusional disorder, etc.)
  • •being immunocompromised
  • •receiving corticosteroid treatments
  • •being pregnant

研究组 & 干预措施

Guided Imagery

Experimental

The intervention consists of three audio-recorded guided imagery scripts formatted as three separate tracks on one CD. Each track is 30 minutes in length and is to be used in a recommended order for the first 6 weeks of the intervention and then used in any order for the follow-up weeks, 7 through 10. Project participants will be instructed to use each CD track, as prescribed, a minimum of once daily. CD Track 1 is a basic relaxation entrainment script; CD track 2 is a pleasant scene imagery script; CD track 3 is a well body imagery script.

干预措施: Guided Imagery (Other)

control

No Intervention

Participants in the control group will be instructed to maintain their FM treatment regimens as reported at baseline.

结局指标

主要结局

Fatigue

时间窗: 10th week

Measured by Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), PROMIS Fatigue Short-Form, and Brief Fatigue Invebtory (BFI) and 17 cytokines

Fatigue

时间窗: baseline

Measured by Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), PROMIS Fatigue Short-Form, and Brief Fatigue Invebtory (BFI) and 17 cytokines

Fatigue

时间窗: 6th weeks

Measured by Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), PROMIS Fatigue Short-Form, and Brief Fatigue Invebtory (BFI) and 17 cytokines

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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