Psychological Wellbeing in Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

Official title:

Psychological Wellbeing in Adults With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094820
• Other study ID #: HJ2012
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: January 14, 2015
• Start date: May 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Royal Holloway University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Chronic Fatigue Syndrome as defined by NICE (2007).

2. Aged 18 or over

3. English speaking

Exclusion Criteria:

1. Insufficient English language skills to participate without the use of an interpreter.

2. Insufficient ability to read and write independently.

3. Incapacity to consent to the study as defined by the Mental Capacity Act (2005).

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Locations

Country	Name	City	State
United Kingdom	Lincolnshire Hospital Foundation Trust	Lincolnshire
United Kingdom	Royal London Hospital for Integrated Medicine	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Holloway University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ryff (1989) Scale of Psychological Well-Being (SPWB)	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.	1 time point	No
Secondary	The Scale of Positive and Negative Experience (SPANE; Diner, Wirtz, Tov et al., 2009)	a brief 12-item scale, with six items corresponding to positive emotions and six items corresponding to negative emotions. Each item is scored on a scale ranging from 1 to 5, where 1 represents "very rarely or never" and 5 represents "very often or always." The positive and negative scales are scored separately and each range from 6 to 30. The two scores can also be combined as a scale of balanced affect. Internal consistency is good (ranging from 0.81-0.89 across the scales), as is temporal stability (0.62-0.68). The SPANE has performed well in terms of convergent validity with other measures of emotion, well-being, happiness, and life satisfaction.	1 time point	No
Secondary	The Meaning in Life Questionnaire (Steger, Frazier, Oishi et al., 2006)	A brief 10-item questionnaire designed to measure two dimensions of meaning in life: (1) Presence of Meaning (the subjective sense that one's life is meaningful), and (2) Search for Meaning (drive and orientation toward finding meaning in one's life). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (Absolutely True) to 7 (Absolutely Untrue). In non-clinical populations both subscales have demonstrated good internal consistency, with cronbach's alphas ranging from 0.86-0.88. In terms of convergent validity, the Presence of Meaning subscale has been found to correlate positively with life satisfaction, positive emotions, extraversion and agreeableness. It has also been found to correlate negative with depression, negative emotions and neuroticism. The Search for Meaning subscale in contrast has been found to correlate positively with neuroticism, depression and several negative emotions.	1 time point	No
Secondary	The Multidimensional Fatigue Inventory (MFI -20; Smets, Garssen, Bonke & Haes, 1995)	A 20-item self-report instrument consisting of five scales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue. Each scale contains four items rated on a scale of zero to 5 with the scale score of zero having the anchor of entirely true and the scale score of 5 having the anchor of no, not true. In a CFS sample all subscales have demonstrated good internal consistency (general fatigue = 0.89; physical fatigue =0.82, mental fatigue= 0.92; reduced activity= 0.90; reduced motivation= 0.77).	1 time point	No
Secondary	The Pain Visual Analog Scale (VAS; McCormack, Horne & Sheather, 1988)	Assesses subjective perception of pain based on a 10-cm line (0-10, no pain to pain as bad as it could be). It is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). It takes less than 1 minute to complete (Hawker, Mian, Kendzerska & French, 2011).	1 time-point	No
Secondary	The Hospital Anxiety and Depression Scale (HADS)	A 14-item measures anxiety and depression in people with physical health problems, excluding items related to somatic symptoms that are higher in these populations. It is widely used and has demonstrated good reliability and validity. A score of above 10 on either subscale is considered clinically significant.	1 time-point	No