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临床试验/NCT02094820
NCT02094820已完成不适用

Psychological Wellbeing in Adults With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis

Royal Holloway University2 个研究点 分布在 1 个国家目标入组 61 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
发起方
入组人数
61
试验地点
2
主要终点
Ryff (1989) Scale of Psychological Well-Being (SPWB)

研究概览

简要总结

Objectives: Chronic Fatigue Syndrome (CFS) is a medically unexplained condition characterized by severe and disabling fatigue. To date much research has focused on finding out whether CFS is caused by mainly physical or psychological factors. Perhaps as a result of this, few studies have examined the relationship between CFS and quality of life, in particular, more positive aspects of mental health, such as an individual's sense of purpose, autonomy and close relationships.

This study will address these limitations by examining Ryff's (1989) six domains of psychological well-being (PWB), and other aspects of well-being including positive emotions, in CFS. It will also examine the relationship between measures of symptomology, emotional distress and PWB.

Method: This is a cross-sectional, questionnaire-based study with a clinical sample of adults with CFS. Participants will complete valid measures of well-being and symptomology.

Results: We expect to find that compared to general population norms, individuals with CFS score lower on measures of PWB. Secondly, we expect PWB dimensions will be related to symptom measures. There are however, no grounds for making strong predictions.

Implications: This study will advance our understanding of quality of life in CFS. Clinically, it has the potential to enrich and inform therapeutic interventions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Chronic Fatigue Syndrome as defined by NICE (2007).
  • Aged 18 or over
  • English speaking

排除标准

  • Insufficient English language skills to participate without the use of an interpreter.
  • Insufficient ability to read and write independently.
  • Incapacity to consent to the study as defined by the Mental Capacity Act (2005).

结局指标

主要结局

Ryff (1989) Scale of Psychological Well-Being (SPWB)

时间窗: 1 time point

The Ryff (1989) Scale of Psychological Well-Being (SPWB) is comprised of 54 items, equally divided into 6 scales: autonomy, environmental mastery, personal growth, purpose in life, positive relations with others, and self-acceptance. Responses are given on a scale of 1-6 (strongly disagree to strongly agree), with some items being reverse-scored. Internal consistency is good across all scales (alpha range = 0.86- 0.93), as is test-retest reliability over a 6- week period (range = 0.81-0.88). In terms of its convergent validity the SPWB has been found to correlate positively with other measures of positive functioning (i.e., life satisfaction, affect balance, self- esteem, internal control, and morale), with coefficients ranging from .25 to .73. Furthermore, correlations with measures of negative functioning (i.e., powerful others, chance control, depression) have been negative and significant, with coefficients ranging from -0.30 to -0.60.

次要结局

  • The Scale of Positive and Negative Experience (SPANE; Diner, Wirtz, Tov et al., 2009)(1 time point)
  • The Meaning in Life Questionnaire (Steger, Frazier, Oishi et al., 2006)(1 time point)
  • The Multidimensional Fatigue Inventory (MFI -20; Smets, Garssen, Bonke & Haes, 1995)(1 time point)
  • The Pain Visual Analog Scale (VAS; McCormack, Horne & Sheather, 1988)(1 time-point)
  • The Hospital Anxiety and Depression Scale (HADS)(1 time-point)

研究者

发起方
Royal Holloway University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hannah Jackson

Miss

Royal Holloway University

研究点 (2)

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