Chronic Fatigue SyndromeNCT02094820
Psychological Wellbeing in Chronic Fatigue Syndrome
An observational study of Chronic Fatigue Syndrome, run by Royal Holloway University at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Fatigue Syndrome
- How many people
- 61 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2014to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults referred to a chronic fatigue syndrome service
Who may be able to join
- Chronic Fatigue Syndrome as defined by NICE (2007).
- Aged 18 or over
- English speaking
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Lincolnshire Hospital Foundation Trust
Lincolnshire
Royal London Hospital for Integrated Medicine
London
About this study
Official title: Psychological Wellbeing in Adults With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
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.
Read more
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
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Study | Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 time point
Secondary outcomes (5)
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.
Measured: 1 time point
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.
Measured: 1 time point
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).
Measured: 1 time point
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).
Measured: 1 time-point
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.
Measured: 1 time-point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Holloway University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Jackson, Royal Holloway University
- Investigators
- Hannah Jackson, Principal investigator, Royal Holloway University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094820
- Sponsor's protocol ID
- HJ2012
- Status last verified
- Jan 2015
- First submitted
- 20 Mar 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Wellbeing in Adults With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
- ClinicalTrials.gov ID
- NCT02094820
- Acronym / sponsor ID
- HJ2012
- Conditions
- Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Royal Holloway UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Study | – | –Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults referred to a chronic fatigue syndrome service
Key inclusion criteria (3 listed)
- Chronic Fatigue Syndrome as defined by NICE (2007).
- Aged 18 or over
- English speaking
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ryff (1989) Scale of Psychological Well-Being (SPWB)
Time frame: 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.
5 secondary outcomes
The Scale of Positive and Negative Experience (SPANE; Diner, Wirtz, Tov et al., 2009)
Time frame: 1 time point
The Meaning in Life Questionnaire (Steger, Frazier, Oishi et al., 2006)
Time frame: 1 time point
The Multidimensional Fatigue Inventory (MFI -20; Smets, Garssen, Bonke & Haes, 1995)
Time frame: 1 time point
The Pain Visual Analog Scale (VAS; McCormack, Horne & Sheather, 1988)
Time frame: 1 time-point
The Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 time-point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
Related trials for Chronic Fatigue Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Jackson principal investigator
Royal Holloway University London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome, run by Royal Holloway University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ryff (1989) Scale of Psychological Well-Being (SPWB) (time frame: 1 time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2015.