Clinical trial NCT02094820: Psychological Wellbeing in Chronic Fatigue Syndrome
Official title: Psychological Wellbeing in Adults With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Fatigue Syndrome
Lead sponsor: Royal Holloway University
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults referred to a chronic fatigue syndrome service

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Ryff (1989) Scale of Psychological Well-Being (SPWB)
timeFrame: 1 time point
Secondary outcomes:
measure: The Scale of Positive and Negative Experience (SPANE; Diner, Wirtz, Tov et al., 2009)
timeFrame: 1 time point
measure: The Meaning in Life Questionnaire (Steger, Frazier, Oishi et al., 2006)
timeFrame: 1 time point
measure: The Multidimensional Fatigue Inventory (MFI -20; Smets, Garssen, Bonke & Haes, 1995)
timeFrame: 1 time point
measure: The Pain Visual Analog Scale (VAS; McCormack, Horne & Sheather, 1988)
timeFrame: 1 time-point
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 time-point
Other outcomes:
Locations:
city: Lincolnshire
country: United Kingdom
facility: Lincolnshire Hospital Foundation Trust
city: London
country: United Kingdom
facility: Royal London Hospital for Integrated Medicine
Study officials:
affiliation: Royal Holloway University London
name: Hannah Jackson
role: PRINCIPAL_INVESTIGATOR
References: