Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome

Few studies have examined therapist effects and therapeutic alliance (TA) in treatments for chronic fatigue syndrome (CFS). Therapist effects are the differences in outcomes achieved by different therapists. TA is the quality of the bond and level of agreement regarding the goals and tasks of therapy. Prior research suffers the methodological problem that the allocation of therapist was not randomized, meaning therapist effects may be confounded with selection effects. We used data from a randomized controlled treatment trial of 296 people with CFS. The trial compared pragmatic rehabilitation (PR), a nurse led, home based self-help treatment, a counselling-based treatment called supportive listening (SL), with general practitioner treatment as usual. Therapist allocation was randomized. Primary outcome measures, fatigue and physical functioning were assessed blind to treatment allocation. TA was measured in the PR and SL arms. Regression models allowing for interactions were used to examine relationships between (i) therapist and therapeutic alliance, and (ii) therapist and average treatment effect (the difference in mean outcomes between different treatment conditions). We found no therapist effects. We found no relationship between TA and the average treatment effect of a therapist. One therapist formed stronger alliances when delivering PR compared to when delivering SL (effect size 0.76, SE 0.33, 95% CI 0.11 to 1.41). In these therapies for CFS, TA does not influence symptomatic outcome. The lack of significant therapist effects on outcome may result from the trial’s rigorous quality control, or random therapist allocation, eliminating selection effects. Further research is needed

Structured transition is associated with improved outcomes in diabetes

This study aimed to assess the effectiveness of a structured transition tool for the successful transitioning of young people (YP) with type 1 diabetes from paediatric to adult diabetic services. In a single-centre retrospective observational study, case notes were reviewed for YP with type 1 diabetes transitioning between paediatric and adult services between 2011–2014. YP were split into those who had participated in the ‘Ready Steady Go’ (RSG) structured transition programme as part of their routine care, and those who had not (RSG versus non-RSG). Between group comparisons were made for changes in objective measures before and after transfer to adult services including: glycated haemoglobin (HbA1c), non-high density lipoprotein (HDL) cholesterol concentrations and non-elective diabetes-related hospital admissions. Case note documentation of advice given during consultations was also reviewed. Data were available for 106 YP. Of these, 71 had participated in the RSG transition programme. Programme use was associated with lower non-elective, diabetes-related hospital admissions and lower non-HDL cholesterol concentrations compared with historical controls. The rise in HbA1c typically observed in YP during early adult life did not occur in the intervention group. No differences were observed in total cholesterol concentrations and body mass index. Trends towards higher rates of documentation of key topic discussions in the RSG group were significant for contraception and pregnancy. Due to the observed improvements in markers of metabolic and diabetes control, this study supports the role of a structured transition tool such as the ‘Ready Steady Go’ programme for YP with type 1 diabetes.</p

Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website (MIBS trial)

Background: IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affectquality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance,lifestyle advice and drug therapies, but many suffer ongoing symptoms. A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT selfmanagement programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs.Methods/Design: The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonlyprescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose(bulkingagent)and Regul8, the CBT based self-management website. 135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimalemail support, or no website, thus creating 9 groups.Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks asthe primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial.Discussion: This pilot will provide valuable information for a larger trial. Determining the effectiveness ofcommonly used drug treatments will help patients and doctors make informed treatment decisions regarding drugmanagement of IBS symptoms, enabling better targeting of treatment. A web-based self-management CBT programme for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. Assessment of the amount of email or therapist support required for the website willenable economic analysis to be undertaken.Trial Registration: ClinicalTrials.gov Identifier (NCT number): NCT00934973

The development and initial validation of a new measure of lay definitions of health: the wellness beliefs scale

The objective was to develop a psychometrically sound questionnaire measure of lay people's beliefs about the importance of different signs of wellness (the Wellness Beliefs Scale, WBS). Questionnaire items were derived from qualitative literature. Nine hundred and forty two people (recruited from the community and patient-support groups) participated in two cross-sectional studies using paper and web-based questionnaires. Study 1 participants completed the initial version of the WBS and Study 2 participants completed the revised version of the WBS and existing measures of health beliefs, illness perceptions and health status. Factor analysis confirmed that the WBS measures three distinct wellness beliefs: belief in the importance of biomedical (absence of illness), functional (ability to carry out daily tasks) and wellbeing (vitality) indicators of wellness. All the three resulting subscales had good internal consistency and could be used to cluster participants into three groups. Wellness belief scores were related to gender, health status and subjective health; there were few associations with health beliefs. In conclusion, the WBS is a promising new measure of three distinct wellness beliefs, with good initial psychometric properties, which could potentially be used to better target individualised health promotion interventions