HRA registered CFS studiesthat could be of interest

Esther12

Esther12

Senior Member (Voting Rights)
I can be bad at finding stuff, but I was just looking through the HRA website and found reference to a few old CFS studies that I've not see published results for. I'm posting them here, along with a few others that were interesting to me, in case it would be of interest to anyone else... or someone else might be able to tell me I've missed on obvious publication? Maybe I should have given a couple of these their own threads? Not sure.

Edit: Dolphin found this one here: http://psycnet.apa.org/doiLanding?doi=10.1037/hea0000341

Investigating the impact of fatigue and anxiety provocation in CFS

Full title The effect of anxiety and fatigue provocation on Autonomic Nervous System Activity in Chronic Fatigue Syndrome
Research type Research study
IRAS ID 120810
Contact Name Trudie Chalder
Contact Email
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary This study will investigate the impact of fatigue and anxiety provocation on Autonomic Nervous System (ANS)activity in those with CFS. It will also investigate how underlying emotion processing and personality traits impact upon the experience of fatigue and anxiety.40 patients diagnosed with Chronic Fatigue Syndrome will be recruited from CFS Research and Treatment Unit (South London and Maudsley NHS Trust/ King’s College London) before undergoing treatment, along with 40 matched healthy control participants. All participants will receive a set of questionnaires to complete at home which measure various personality and emotion processing traits. Participants will then attend an experimental session at the Chronic Fatigue Unit. During this time they will be attached to equipment which measures their Heart Rate (HR) and Skin Conductance Resistance (SCR) both of which are markers of Autonomic Nervous System activity. After baseline recordings of HR and SCR have been taken, participants will be shown a sequence of videos designed to provoke states of anxiety, fatigue or relaxation. After each clip, the participant will rate their feelings of fatigue and anxiety. Participants will then be required to rate the extent to which they may have been suppressing their feelings. A 2 minute walk test will also be conducted as a measure of fitness. After the CFS patients have completed a course of treatment at the unit they will be invited to return for a follow up session in which the original set of questionnaires will be completed again and baseline recordings of HR and SCR taken.
REC Name London - Riverside Research Ethics Committee
REC Reference 13/LO/1112
REC Opinion
Further Information Favourable Opinion


Date of REC Opinion 17 September 2013
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http://www.hra.nhs.uk/news/research...ct-of-fatigue-and-anxiety-provocation-in-cfs/


Edit: Dolphin pointed out that the following is discussed here, and some results are available: https://www.s4me.info/index.php?thr...-in-people-with-cfs-me-a-diagnostic-accuracy-
A physical diagnosis of CFS/ME: Examining the accuracy of a new method

Full title Examining the accuracy of a physical diagnostic technique For Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
Research type Research study
IRAS ID 113916
Contact Name Raymond N Perrin
Contact Email
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary
REC Name North West - Lancaster Research Ethics Committee
REC Reference 12/NW/0877
REC Opinion
Favourable Opinion

Favourable Opinion

Date of REC Opinion 18 December 2012
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http://www.hra.nhs.uk/news/research...cfsme-examining-the-accuracy-of-a-new-method/

Some further info on the above here: http://bedfordintegrativehealth.co....-clinic-summary-of-new-research-project-2013/

Attitudes to mental illness in patients with chronic fatigue syndrome

Full title Attitudes to mental illness in Chronic fatigue syndrome compared to psoriasis
Research type Research study
IRAS ID 141792
Contact Name Hugh Rickards
Contact Email
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary This research will explore attitudes to mental illness in patients with Chronic fatigue syndrome (CFS) compared with psoriasis patients. This is an important area to explore as research has shown beliefs about the unacceptability of experiencing or expressing negative thoughts and emotions play an important role in the development and maintenance of CFS. This could be explained by the fact that CFS patients have a more negative attitude to mental illness and seeking help for psychological problems. CFS is a serious and debilitating condition characterised by physical and mental fatigue in addition to other symptoms such as muscle pain and headaches. Despite its severity in terms of disability and its costs to society in the form of informal care and lost employment, very little is known about its cause and treatments are limited in what they can achieve. Therefore it is important that this study is carried out to improve understanding of the factors behind the condition. This study will involve adult patients of working age. Participants will be required to answer a questionnaire which explores opinions on mental illness, assesses attitudes towards seeking professional psychological help, measures depression and records demographic information. Psoriasis patients will be used a comparison group as this is a long term condition with similar rates of depression and anxiety to CFS as both these factors could affect attitude to mental illness. CFS patients will be recruited from the Barberry mental health service, psoriasis patients will be recruited from the Queen Elizabeth hospital Birmingham.
REC Name North West - Haydock Research Ethics Committee
REC Reference 14/NW/0029
REC Opinion
Favourable Opinion

Favourable Opinion

Date of REC Opinion 10 January 2014
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http://www.hra.nhs.uk/news/research...ss-in-patients-with-chronic-fatigue-syndrome/

continued in next post...
 
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A couple of more recent Crawley ones:

Investigating outcome in children with CFS/ME

Full title Investigating Outcome in children with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)

Research type Research study

IRAS ID 146840

Contact Name Esther Crawley

Contact Email esther.crawley@bristol.ac.uk

Sponsor organisation Royal National Hospital for Rheumatic Diseases

Eudract number

ISRCTN number

Clinicaltrials.gov identifier

Additional reference number fields

Research summary This study will: define recovery in paediatric CFS/ME; investigate how many children recover after accessing a specialist service; when they recover and what factors predict recovery. Design: Longitudinal cohort and focus groups. LONGITUDINAL COHORT: We will recruit children attending a specialist CFS/ME service in the Bath/Bristol area. Children will be eligible if they have a diagnosis of CFS/ME and are between 8 and 18 years old. Participants will be asked to complete follow up questionnaires at 6, 12 and 24 months either using paper questionnaires (currently used clinically) or completing questionnaires on-line. FOCUS GROUPS: We will run focus groups (3 for children, 3 for their parents and 1 for clinicians) to define recovery and outcome. The focus groups will explore how recovery should be defined and what the smallest difference in fatigue and disability is beneficial. This will allow us to define the Minimum Clinically Important Difference (MCID) used to calculate how many are participants are need in trials. For the focus groups, we want children who have and have not recovered. We will therefore recruit children (and their parents) at assessment and we will therefore also contact children who have been discharged from the Bath/Bristol service and invite them to take part in the focus groups. Children will be eligible for the focus groups if they are have a diagnoses of CFS/ME and are age 12 to 18. We will recruit clinicians from the British Association for CFS/ME. Focus groups will be run in either Bath or Bristol, will last between one and two hours with a break in the middle. Analysis: Focus groups will aim to reach consensus. The definition of recovery will be used to define recovery in the longitudinal cohort.

REC Name North West - Preston Research Ethics Committee

REC Reference 14/NW/0170

REC Opinion
Favourable Opinion




Date of REC Opinion 17 March 2014
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http://www.hra.nhs.uk/news/research-summaries/investigating-outcome-in-children-with-cfsme/

It looks like stuff is happening with MAGENTA, where the feasibility study is being folded in to the full trial. Someone was just explaining concerns they had about what SMILE did with this. HRA entry:

MAGENTA: Graded Exercise Therapy Vs Activity Management

Full title The feasibility and acceptability of conducting a trial investigating the effectiveness and cost effectiveness of Graded Exercise Therapy compared to Activity Management for paediatric CFS/ME: A feasibility randomised controlled trial
Research type Research study
IRAS ID 176764
Contact Name Esther Crawley
Contact Email esther.crawley@bristol.ac.uk
Sponsor organisation Royal United Hospitals Bath NHS Foundation Trust
Eudract number
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME) in children is relatively common affecting up to 2% of secondary school children. Although national guidance recommends that children with CFS/ME are offered either Cognitive Behavioural Therapy (CBT), Graded Exercise Therapy (GET) or Activity Management, there is no evidence for the effectiveness or cost effectiveness and acceptability of GET for children with CFS/ME. This study will investigate the feasibility and acceptability of conducting a Randomised Controlled Trial (RCT) to investigate the effectiveness and cost-effectiveness of Graded Exercise Therapy compared to Activity Management for the treatment of CFS/ME in children. We will interview participants, their parents, researchers and clinicians to improve the study and the interventions. If MAGENTA is feasible, we will move on to a full study and find out whether GET is effective and cost effective. The study will be conducted in three specialist services: Bath/Bristol, Cambridge and Newcastle. Children will be eligible if they have CFS/ME, are aged 8-17 and are not severely affected, are not referred for CBT at the first assessment and are able to attend follow up appointments. The study is funded by the NIHR.
REC Name South West - Frenchay Research Ethics Committee
REC Reference 15/SW/0124
REC Opinion
Further Information Favourable Opinion


Date of REC Opinion 3 July 2015
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The newly updated MAGENTA ISRCTN entry: http://www.isrctn.com/ISRCTN23962803

And now there's this newly approved [non-Crawley] study:

A couple-based psychological intervention for chronic fatigue syndrome

Full title A couple-based psychological intervention for chronic fatigue syndrome: a pilot study.
Research type Research study
IRAS ID 221300
Contact Name Marion Cuddy
Contact Email
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary Chronic fatigue syndrome (CFS) is associated with significant levels of disability. Managing life with CFS can be challenging, and people with CFS are at increased risk of experiencing depression and anxiety, with their partners also reporting higher rates of emotional distress. Relationships can interact with physical and mental health in several ways. For example, distressed relationships can increase the risk of depression and other health problems. Conversely, partners and family members can offer valuable support both on an emotional level and in promoting health-related lifestyle changes. There is evidence that cognitive behavioral therapy (CBT) can help people with CFS to manage their symptoms. However, fatigue and other symptoms experienced by this patient group can make CBT, which is quite an ‘active’ therapy, quite difficult to engage in. For these reasons, we believe that involving partners in a constructive manner in a psychological intervention for patients affected by CFS could enhance the effectiveness of the intervention and prove beneficial to partners. Therefore, we plan to develop a cognitive behavioural couple-based therapy (CBCT) for people with CFS and their partners, and to explore the effectiveness of the intervention in a group of 10 couples. We will develop a treatment manual based on the current literature on CBT for CFS and CBCT for people with medical problems and consultation with a lay advisory group. The study will be based in a primary care psychological therapies service (Talking Therapies Southwark). Patients referred to the service with a diagnosis of CFS and who are in a committed relationship will be invited to participate. After a telephone interview, eligible couples will be offered a course of 12-15 sessions of CBCT. Participants will be asked to complete questionnaire assessments before therapy starts and at the end of therapy, and also 6 months after the end of therapy.
REC Name London - Westminster Research Ethics Committee
REC Reference 17/LO/1093
REC Opinion
Further Information Favourable Opinion

Further Information Favourable Opinion


Date of REC Opinion 17 July 2017
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http://www.hra.nhs.uk/news/research...al-intervention-for-chronic-fatigue-syndrome/

Looks like the above is funded by the BABCP, using subjective self-report outcomes and is not randomised, with maybe some sort of waiting list control group:

https://www.isrctn.com/ISRCTN16045700

Seems odd for the BABCP to be funding something like this.
 
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Esther12 said:
http://www.hra.nhs.uk/news/research...ct-of-fatigue-and-anxiety-provocation-in-cfs/
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Health Psychol. 2016 Sep;35(9):979-86. doi: 10.1037/hea0000341. Epub 2016 May 16.
Emotional suppression in chronic fatigue syndrome: Experimental study.
Rimes KA1, Ashcroft J1, Bryan L1, Chalder T1.
Author information

Abstract
OBJECTIVE:
Emotional processing differences in chronic fatigue syndrome (CFS) have been reported but have rarely been investigated experimentally. This study used self-report, observer ratings, and electrodermal responses to test hypotheses about emotion suppression and autonomic reactivity.

METHODS:
Eighty adults with CFS and 80 healthy controls (HC) watched a distressing film clip. Half of each group were instructed to suppress their emotions and half were told to express their feelings as they wished. Their reactions were filmed and rated by independent observers. Electrodermal activity (skin conductance response) was used as a measure of sympathetic nervous system arousal.

RESULTS:
CFS participants reported higher anxiety and sadness than the HC, both before and after the film. However, observers rated the CFS group as having lower emotional expression than HC in both emotional suppression and expression choice conditions. Beliefs about the unacceptability of negative emotions were associated with greater self-reported suppression. Electrodermal responses were greater in the CFS group than HC participants. Higher skin conductance responses were associated with larger posttask increases in fatigue in the CFS participants but not in the HC.

CONCLUSIONS:
CFS participants had lower observer-rated emotional expression than HC, despite greater distress and higher autonomic arousal. This may have implications for their ability to access social support at times of stress. As the degree of autonomic arousal was associated with short-term increases in fatigue in the CFS participants, this requires further investigation as a contributory factor for this condition. (PsycINFO Database Record

(c) 2016 APA, all rights reserved).

PMID:

27183308

DOI:

10.1037/hea0000341
 
Esther12 said:
http://www.hra.nhs.uk/news/research...cfsme-examining-the-accuracy-of-a-new-method/

Some further info on the above here: http://bedfordintegrativehealth.co....-clinic-summary-of-new-research-project-2013/
Click to expand...
https://www.s4me.info/index.php?thr...me-a-diagnostic-accuracy-study.351/#post-5856

http://clok.uclan.ac.uk/20386/

CAN PHYSICAL ASSESSMENT TECHNIQUES AID DIAGNOSIS IN PEOPLE WITH CHRONIC FATIGUE SYNDROME/MYALGIC ENCEPHALOMYELITIS? A DIAGNOSTIC ACCURACY STUDY



Hives, Lucy, Bradley, Alice, Richards, James, Sutton, Chris J, Selfe, James, Basu, Bhaskar, Maguire, Kerry, Sumner, Gail, Gaber, Tarek et al

ABSTRACT


Objective: To assess 5 physical signs to see whether they can assist in the screening of patients with CFS/ME, and potentially lead to quicker treatment.

Methods: This was a diagnostic accuracy study with inter-rater agreement assessment. Participants recruited from 2 NHS hospitals, local CFS/ME support groups and the community were examined by three practitioners on the same day in a randomized order. Two Allied Health Professionals (AHPs) performed independent examinations of physical signs including; postural/mechanical disturbances of the thoracic spine, breast varicosities, tender Perrin’s Point, tender coeliac plexus and dampened cranial flow. A physician conducted a standard clinical neurological and rheumatological assessment, whilst looking for patterns of illness behaviour. Each examination lasted approximately 20 minutes.

Results: Ninety-four participants were assessed, 52 CFS/ME patients and 42 non-CFS/ME controls, aged 18-60. Cohen’s kappa revealed agreement between the AHPs was substantial for presence of the tender coeliac plexus (κ=0.65, p<0.001) and moderate for postural/mechanical disturbance of the thoracic spine (κ=0.57, p<0.001) and Perrin’s point (κ=0.56, p<0.001). A McNemar’s test found no statistically significant bias in the diagnosis by the experienced AHP relative to actual diagnosis, (p=1.0) and a marginally non-significant bias by the newly trained AHP, p=0.052. There was however, a significant bias in the diagnosis made by the physician relative to actual diagnosis, (p<0.001), indicating poor diagnostic utility of the clinical neurological and rheumatological assessment.

Conclusions: Using the physical signs appears to improve the accuracy of identifying people with CFS/ME and shows agreement with current diagnostic techniques, however the present study concludes that only 2 of these may be needed. Examining for physical signs is both quick and simple for the AHP and may be used as an efficient screening tool for CFS/ME. This is a small single centre study and therefore further validation in other centres and larger populations is needed.
 
http://www.hra.nhs.uk/news/research...tivity-monitors-with-young-people-with-cfsme/

Exploring the use of activity monitors with young people with CFS/ME

Full title Exploring the use of activity monitors with young people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
Research type Research study
IRAS ID 161923
Contact Name Joan Simons
Contact Email joan.simons@open.ac.uk
Sponsor organisation Milton Keynes Hospital NHS Foundation Trust
Eudract number
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary The purpose of this study is to pilot assess the use of activity monitors within the pathway for treating young people with Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME). The patients are currently treated using graded exercise therapy GET) which has shown to be effective and will not be the focus of this pilot. This pilot will investigate the compliance to a GET; development of positive carer support for young people following GET; and development of self-management strategies by young people with CFS/ME.
REC Name East of Scotland Research Ethics Service REC 2
REC Reference 15/ES/0025
REC Opinion
Further Information Favourable Opinion

Date of REC Opinion 31 March 2015
 
http://www.hra.nhs.uk/news/research-summaries/psychological-factors-in-cfsme-ibs/

Psychological Factors in CFS/ME & IBS

Full title Psychological Factors in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis & Irritable Bowel Syndrome
Research type Research study
IRAS ID 171274
Contact Name Hazel Carrick
Contact Email hc553@bath.ac.uk
Sponsor organisation University of Bath
Eudract number
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary The term Medically Unexplained Symptoms (MUSs) is used to described physical symptoms, which doctors can’t find a medical cause for. MUS can also refer to specific disorders, such as Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) and Irritable Bowel Syndrome (IBS), which will be the focus of this study. It is agreed that MUSs are best understood using the Cognitive Behavioural Therapy (CBT) model (Deary, Chalder, & Sharpe, 2007). This model looks at how there are many different factors involved in these problems, such as levels of low mood & anxiety, the nature of physical symptoms, beliefs about symptoms and behavioural responses to symptoms. More research is needed to find out how these factors impact CFS/ME & IBS. More research is also needed to find out how these factors are similar and different in CFS/ME & IBS. This study will look at these issues. Patients with CFS/ME & IBS will be asked to completed questionnaires looking at these factors. The way people answer will help us to understand the things that are shared and different in CFS/ME & IBS, so that we can develop treatments that are tailored to each condition.
REC Name Wales REC 7
REC Reference 15/WA/0298
REC Opinion
Favourable Opinion

Date of REC Opinion 27 August 2015
 
http://www.hra.nhs.uk/news/research...for-children-with-cfsme-cognitive-interviews/

Developing a PROM for Children with CFS/ME: Cognitive Interviews

Full title Developing a Patient Reported Outcome Measure (PROM) for Children with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). Cognitive Interviews with Children.
Research type Research study
IRAS ID 194846
Contact Name Roxanne Parslow
Contact Email roxanne.potgieter@bristol.ac.uk
Sponsor organisation Royal United Hospitals Bath NHS Foundation Trust
Eudract number
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary This study will: Evaluate whether children understand and interpret questions in a new paediatric CFS/ME Patient Reported Outcome Measure (PROM)/ questionnaire the way that was intended. Design: Cognitive interviews Recruitment: We will recruit children attending a specialist CFS/ME service in the Bath/Bristol area. Children will be eligible if they have a diagnosis of CFS/ME and are between 8 and 18 years old and are mild to moderately affected (not housebound). We will recruit children at assessment and follow up. Cognitive Interviews: In the cognitive interview process, patients are asked to say what they are thinking as they work through the questionnaire—to think aloud and then they will be asked open ended semi structured interview questions about how they make sense of questionnaire items. Cognitive interviews will take up to 30 minutes. Analysis: Interviews will be audio-recorded and transcribed. We will use thematic analyses in an iterative process. The results will inform the development of the PROM.
REC Name West of Scotland REC 3
REC Reference 16/WS/0011
REC Opinion
Further Information Favourable Opinion

Date of REC Opinion 25 January 2016
 
http://www.hra.nhs.uk/news/research...in-paediatric-chronic-fatigue-syndrome-cfsme/

Depression in Paediatric Chronic Fatigue Syndrome (CFS/ME)

Full title Depression in Paediatric Chronic Fatigue Syndrome (CFS/ME)
Research type Research study
IRAS ID 203495
Contact Name Maria Loades
Contact Email m.e.loades@bath.ac.uk
Sponsor organisation University of Bristol
Eudract number
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary Chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME) affects approximately 1 - 2 teenagers in every 100. It interferes significantly with their day-to-day lives. For example, on average, children and young people with CFS/ME miss one year of school. We think that about 1 in 3 children and young people with CFS/ME also have depression. Those with depression seem to be more disabled, experience more pain, and don’t seem to recover as well from CFS/ME. My research aims to improve the recognition of teenagers who have both CFS/ME and depression. It will result in us knowing how to identify depression and who is most at risk of getting depression. To find out how many teenagers with CFS/ME actually have depression and how best to identify them, I will recruit teenagers with CFS/ME after their first appointment with the specialist paediatric CFS/ME service in Bath. Teenagers with CFS/ME will be interviewed to assess depression, and asked them to fill in two short questionnaires about symptoms of depression. They can choose to be interviewed by Skype or face-to-face, at home or at the hospital. I will analyse how good the questionnaires are at picking up depression in these patients so that we know which questionnaire is best to use. I will also ask the young people to complete the questionnaires again 6 months after their interview.
REC Name South West - Frenchay Research Ethics Committee
REC Reference 16/SW/0136
REC Opinion
Further Information Favourable Opinion

Date of REC Opinion 1 July 2016
 
http://www.hra.nhs.uk/news/research...-is-fitnet-nhs-for-children-and-young-adults/


FITNET-NHS: How effective is FITNET-NHS for children and young adults

Full title Investigating the effectiveness and cost-effectiveness of using FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) in the United Kingdom: A randomised controlled trial (FITNET-NHS)
Research type Research study
IRAS ID 211202
Contact Name Esther Crawley
Contact Email esther.crawley@bristol.ac.uk
Sponsor organisation Research and Enterprise Development
Eudract number
ISRCTN number ISRCTN18020851
Clinicaltrials.gov identifier
Additional reference number fields
Research summary This large randomised controlled trial will investigate the relative clinical and cost-effectiveness of the FITNET-NHS intervention compared with Activity Management, among children with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME) who do not have a local NHS specialist CFS/ME service. The FITNET-NHS intervention delivers specialist cognitive behavioural therapy for CFS/ME via the internet. Participants and their parents work through 21 modules and have e-consultations with therapists. Activity Management is used as the comparator in this study as it is recommended by the National Institute of Health & Clinical Excellence (NICE) and is currently the best alternative for children in regions without a local specialist CFS/ME service. Activity Management will be delivered by specialist occupational therapists from Bath Specialist CFS/ME Service via video calls (e.g. Skype). Children will be referred from primary care throughout the UK to the Bath Specialist CFS/ME Service where potentially eligible children will be identified and invited to eligibility screening prior to randomisation. The first phase of the trial is an internal pilot study which will use integrated qualitative methods to examine the acceptability of the treatment arms and the feasibility of recruitment. The full study will assess whether FITNET-NHS is clinically effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS questionnaire. The trial is powered to perform a secondary subgroup analysis investigating the effectiveness of FITNET-NHS in those with co-morbid mood disorders. The full study will also assess whether FITNET-NHS is cost-effective in a cost utility analyses from NHS and social perspective. If FITNET-NHS is effective and cost effective, its provision by the NHS has the potential to deliver substantial health gains for the large number of children suffering from CFS/ME but unable to access treatment because there is no local specialist service.
REC Name South West - Frenchay Research Ethics Committee
REC Reference 16/SW/0268
REC Opinion
Further Information Favourable Opinion

Date of REC Opinion 10 October 2016

 
http://www.hra.nhs.uk/news/research-summaries/explorer-exploring-cfsme-in-younger-children-ages-5-7/

EXPLORER: EXPLORing CFS/ME in youngER children (ages 5-7)

Full title Exploring chronic fatigue syndrome/myalgic encphalomyelitis in children aged 5-7 years.
Research type Research study
IRAS ID 210532
Contact Name Amberly Brigden
Contact Email amberly.brigden@bristol.ac.uk
Sponsor organisation University of Bristol
Eudract number
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary Aims and objectives The overall aim is to develop an understanding of CFS/ME in children age 5-7 years. This will be done by exploring the epidemiology (demographic and clinical characteristics) and capturing the views and experiences of parents/carers and children. To carry out this work effectively it will be important to explore measures and data collection methods appropriate for this age group. Specific objectives are: • To carry out a prospective cohort study of children with CFS/ME aged 5-7 capturing baseline, 6 and 12 month follow-up data. • To carry out integrated qualitative methods to explore the child and parents/ carers experience of the illness as well as explore feasible and acceptable outcome measures and methods of data collection. Design Cohort study with integrated qualitative methods. Part 1: Cohort Study We will recruit children attending a specialist CFS/ME service in the Bath/Bristol area. Children will be eligible if they have a diagnosis of CFS/ME and are between 5- 7 years old. We will collect baseline data and 6 month and 12 month follow up data from patients, parents/ carers, schools and clinicians. Follow-up questionnaires will be completed on-line. Part 2: Integrated qualitative methods For the qualitative interviews we will exclude children who are severely affected. Interviews will take place in clinic, the patient's home or via Skype depending on patient preference. We will invite parents to participate in two interviews and children to participate in one. We anticipate each parental interview to take no longer than one hour and child interviews to take no longer than 30 minutes. We will offer families the opportunity to do a number of shorter interviews if this is preferred.
REC Name South West - Cornwall & Plymouth Research Ethics Committee
REC Reference 16/SW/0335
REC Opinion
Favourable Opinion

Date of REC Opinion 9 December 2016
 
http://www.hra.nhs.uk/news/research-summaries/mitochondrial-dna-copy-number-in-cfs/

Mitochondrial DNA copy number in CFS

Full title Mitochondrial DNA copy number in the blood of those with Chronic Fatigue Syndrome (CFS), with a focus on circulating mtDNA
Research type Research study
IRAS ID 221364
Contact Name Joanna Elson
Contact Email j.l.elson@ncl.ac.uk
Sponsor organisation Newcastle Hospitals NHS Foundation Trust
Eudract number
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary Chronic Fatigue Syndrome (CFS) is a prevalent debilitating condition affecting ~250,000 people in the UK. The fatigue is not alleviated by sleep or rest having a substantial impact on the lives of patients, leaving some bed-bound and in chronic pain. Mitochondria are the “powerhouse” of the cell, the organelle (sub-unit) producing a chemical called ATP that drives cellular functions. Uniquely among the organelles of our cells, mitochondria have their own chromosome, called mitochondrial DNA (mtDNA). MtDNA codes for 13 proteins essential for the cell to produce energy. MtDNA is present in hundreds or thousands of copies within a cell. This mtDNA “copy number” is variable by cell type and between individuals. Mitochondrial patients frequently have mutations of mtDNA. A recent study conducted at Newcastle University by members of the fatigue group in collaboration with the mitochondrial group found that mitochondrial patients suffer from severe fatigue, comparable in 30% of case with CFS patients. Thus, there is growing interest in the role of mitochondria in fatigue, and in CFS. However, a mtDNA sequencing study of 300 CFS patients did reveal any clinically proven mtDNA mutations. Therefore, sequencing mtDNA in CFS patients is unlikely to reveal clinically proven mutations, which would change their diagnosis or could be transmitted to their offspring. However, some studies suggest that mtDNA population variants and changes in mtDNA copy number are associated with different outcomes in complex disease such as diabetes or Parkinson’s, while not causing the disease. Although this work is still a matter of scientific investigation. We would like to conduct analysis on the blood of CFS patients to determine if at a cohort level there are differences in the mtDNA between the patient cohort and controls. Our hope would be that we could elucidate mechanisms of disease, or be able to provide better prognostic information.
REC Name South Central - Oxford C Research Ethics Committee
REC Reference 17/SC/0147
REC Opinion
Further Information Favourable Opinion

Date of REC Opinion 8 June 2017
 
CFS participants had lower observer-rated emotional expression than HC, despite greater distress and higher autonomic arousal.
Click to expand...
Maybe, at least in part, because patients have learned the hard way that showing external signs of emotion, even if proportional and appropriate to the situation, is all too easily and commonly interpreted as evidence of psychopathology.

Heads they win, tails we lose.

Using the physical signs appears to improve the accuracy of identifying people with CFS/ME
Click to expand...
Who would have thought that using physical signs to diagnose a physical disease was the way to go?

The term Medically Unexplained Symptoms (MUSs) is used to described physical symptoms, which doctors can’t find a medical cause for.
Click to expand...
Once again, make one tiny little change to the wording to better reflect the reality, and you get a very different result:
The term Medically Unexplained Symptoms (MUSs) is used to described physical symptoms, which doctors can’t have yet to find a medical cause for.
Click to expand...
 
Well they are being busy little bees aren't they? Love the couples psychotherapy idea - get patients' partners to take over the majority of the therapy! :banghead: And the one about using activity monitors on kids... Creepy :eek:

Dolphin said:
This pilot will investigate the compliance to a GET
Click to expand...

Smacks a bit of big brother don't you think? Or maybe You will comply. :borg:

:sick::sick::sick::sick::sick:
 
I ended up looking at the twitter feed of Rickards, and he seems like exactly the sort of Wessely fan you'd expect: https://twitter.com/hughrickards/with_replies

I wonder what result he'll want from his study?

Attitudes to mental illness in patients with chronic fatigue syndrome

Full title Attitudes to mental illness in Chronic fatigue syndrome compared to psoriasis
Research type Research study
IRAS ID 141792
Contact Name Hugh Rickards
Contact Email
ISRCTN number
Clinicaltrials.gov identifier
Additional reference number fields
Research summary This research will explore attitudes to mental illness in patients with Chronic fatigue syndrome (CFS) compared with psoriasis patients. This is an important area to explore as research has shown beliefs about the unacceptability of experiencing or expressing negative thoughts and emotions play an important role in the development and maintenance of CFS. This could be explained by the fact that CFS patients have a more negative attitude to mental illness and seeking help for psychological problems. CFS is a serious and debilitating condition characterised by physical and mental fatigue in addition to other symptoms such as muscle pain and headaches. Despite its severity in terms of disability and its costs to society in the form of informal care and lost employment, very little is known about its cause and treatments are limited in what they can achieve. Therefore it is important that this study is carried out to improve understanding of the factors behind the condition. This study will involve adult patients of working age. Participants will be required to answer a questionnaire which explores opinions on mental illness, assesses attitudes towards seeking professional psychological help, measures depression and records demographic information. Psoriasis patients will be used a comparison group as this is a long term condition with similar rates of depression and anxiety to CFS as both these factors could affect attitude to mental illness. CFS patients will be recruited from the Barberry mental health service, psoriasis patients will be recruited from the Queen Elizabeth hospital Birmingham.
REC Name North West - Haydock Research Ethics Committee
REC Reference 14/NW/0029
REC Opinion
Favourable Opinion

Favourable Opinion

Date of REC Opinion 10 January 2014
Click to expand...

http://www.hra.nhs.uk/news/research...ss-in-patients-with-chronic-fatigue-syndrome/
 
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