Psychological Wellbeing in Chronic Fatigue Syndrome

NCT02094820 | Completed

• 1 other identifier: HJ2012
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (1)

Single Group Study

Questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults referred to a chronic fatigue syndrome service

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal Holloway University: lead

Study Sites (2)

Lincolnshire Hospital Foundation Trust

Lincolnshire, United Kingdom

Location

Royal London Hospital for Integrated Medicine

London, United Kingdom

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hannah Jackson

  Royal Holloway University London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miss

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 24, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

GB (2)