Randomised controlled trial to improve health and reduce substance use in established psychosis (IMPaCT): cost-effectiveness of integrated psychosocial health promotion.

BACKGROUND: There is mounting evidence that people with severe mental illness have unhealthy lifestyles, high rates of cardiovascular and metabolic diseases, and greater risk of early mortality. This study aimed to assess the cost-effectiveness of a health promotion intervention seeking to improve physical health and reduce substance use in people with psychosis. METHODS: Participants with a psychotic disorder, aged 18-65 years old and registered on an enhanced care approach programme or equivalent were recruited from community mental health teams in six mental health trusts in England. Participants were randomisation to either standard community mental health team care (treatment as usual) or treatment as usual with an integrated health promotion intervention (IMPaCT). Cost-effectiveness and cost-utility analyses from health and social care and societal perspectives were conducted alongside a cluster randomised controlled trial. Total health and social care costs and total societal costs at 12 and 15 months were calculated as well as cost-effectiveness (incremental cost-effectiveness ratios and cost-effectiveness acceptability curves) at 15 months based on quality of life (SF-36 mental and physical health components, primary outcome measures) and quality adjusted life years (QALYs) using two measures, EQ-5D-3 L and SF-36. Data were analysed using bootstrapped regressions with covariates for relevant baseline variables. RESULTS: At 12-15 months 301 participants had full data needed to be included in the economic evaluation. There were no differences in adjusted health and social care costs (£95, 95% CI -£1410 to £1599) or societal costs (£675, 95% CI -£1039 to £2388) between the intervention and control arms. Similarly, there were no differences between the groups in the SF-36 mental component (-0.80, 95% CI -3.66 to 2.06), SF-36 physical component (-0.68, 95% CI -3.01 to 1.65), QALYs estimated from the SF-36 (-0.00, -0.01 to 0.00) or QALYs estimated from the EQ-5D-3 L (0.00, 95% CI -0.01 to 0.02). Cost-effectiveness acceptability curves for all four outcomes and from both cost perspectives indicate that the probability of the health promotion intervention being cost-effective does not exceed 0.4 for willingness to pay thresholds ranging from £0-£50,000. CONCLUSIONS: Alongside no evidence of additional quality of life/clinical benefit, there is also no evidence of cost-effectiveness. TRIAL REGISTRATION: ISRCTN58667926 . Date retrospectively registered: 23/04/2010. Recruitment start date: 01/03/2010.

Transition Care in Anorexia Nervosa Through Guidance Online from Peer and Carer Expertise (TRIANGLE): Study Protocol for a Randomised Controlled Trial.

TRIANGLE is a multicentre trial investigating whether the addition of a novel intervention for patients and carers (ECHOMANTRA) to treatment as usual (TAU) improves outcomes for people with anorexia nervosa (AN). ECHOMANTRA is based on the cognitive interpersonal model of AN and includes assessments, workbooks, videos, online groups and joint Skype sessions for patients and carers. People receiving intensive hospital treatment (N = 380) will be randomised to TAU or TAU plus ECHOMANTRA. Participants will be assessed over an 18-month period following randomisation. The primary outcome is patient psychological well-being at 12 months postrandomisation. Secondary outcomes include (i) patient's weight, eating disorder symptoms, motivation to change, quality of life and number of days in hospital at 12 months postrandomisation and (ii) carer's psychological well-being, burden and skills at 12 months (some outcomes will be assessed at 18 months postrandomisation). The results from this trial will establish the effectiveness of ECHOMANTRA. TRIAL REGISTRATION: ISRCTN registry ISRCTN14644379, 08/12/2016. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

Collaborative Care: The New Maudsley Model.

The aim of this article is to describe the rationale and practice of the New Maudsley collaborative care intervention for families of people with eating disorders. The intervention teaches carers the underpinning theory with practical examples on how to optimize their care giving, communication, and coping skills. This includes moderating high expressed emotion and reducing the tendency to accommodate and/or enable illness behaviors. Transcripts are used to give examples of this approach in action. The emerging evidence base indicates that this approach improves both carer and patient well-being and also is associated with a more efficient use of resources.

Self-Help And Recovery guide for Eating Disorders (SHARED): study protocol for a randomized controlled trial.

BACKGROUND: We describe the theoretical rationale and protocol for Self-Help And Recovery guide for Eating Disorders (SHARED), a trial investigating whether a guided self-care intervention (Recovery MANTRA) is a useful addition to treatment as usual for individuals with anorexia nervosa. Recovery MANTRA, a 6-week self-care intervention supplemented by peer mentorship, is a module extension of the Maudsley Model of Treatment for Adults with Anorexia Nervosa and targets the maintenance factors identified by the cognitive-interpersonal model of the illness. METHODS: Patients accessing outpatient services for anorexia nervosa are randomized to either treatment as usual or treatment as usual plus Recovery MANTRA. Outcome variables include change in body weight at the end of the intervention (primary) and changes in body weight and eating disorder symptoms at immediate and extended follow-up (6-months; secondary). Change is also assessed for the domains identified by the theoretical model, including motivation, hope, confidence to change, positive mood, cognitive flexibility, therapeutic alliance and social adjustment. Feedback from peer mentors is gathered to understand the impact on their own well-being of providing guidance. DISCUSSION: Results from this exploratory investigation will determine whether a larger clinical trial is justifiable and feasible for this affordable intervention, which has potential for high reach and scalability. TRIAL REGISTRATION: ClinicalTrials.gov NCT02336841 .

Clinical effectiveness of a skills training intervention for caregivers in improving patient and caregiver health following in-patient treatment for severe anorexia nervosa: pragmatic randomised controlled trial.

BACKGROUND: Families express a need for information to support people with severe anorexia nervosa. AIMS: To examine the impact of the addition of a skills training intervention for caregivers (Experienced Caregivers Helping Others, ECHO) to standard care. METHOD: Patients over the age of 12 (mean age 26 years, duration 72 months illness) with a primary diagnosis of anorexia nervosa and their caregivers were recruited from 15 in-patient services in the UK. Families were randomised to ECHO (a book, DVDs and five coaching sessions per caregiver) or treatment as usual. Patient (n=178) and caregiver (n=268) outcomes were measured at discharge and 6 and 12 months after discharge. RESULTS: Patients with caregivers in the ECHO group had reduced eating disorder psychopathology (EDE-Q) and improved quality of life (WHO-Quol; both effects small) and reduced in-patient bed days (7-12 months post-discharge). Caregivers in the ECHO group had reduced burden (Eating Disorder Symptom Impact Scale, EDSIS), expressed emotion (Family Questionnaire, FQ) and time spent caregiving at 6 months but these effects were diminished at 12 months. CONCLUSIONS: Small but sustained improvements in symptoms and bed use are seen in the intervention group. Moreover, caregivers were less burdened and spent less time providing care. Caregivers had most benefit at 6 months suggesting that booster sessions, perhaps jointly with the patients, may be needed to maintain the effect. Sharing skills and information with caregivers may be an effective way to improve outcomes. This randomised controlled trial (RCT) was registered with Current Controlled Trials ISRCTN06149665. DECLARATION OF INTEREST: J.T. is a co-author of the book used in the ECHO intervention and receives royalties. COPYRIGHT AND USAGE: © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

Carers' assessment, skills and information sharing (CASIS) trial: a qualitative study of the experiential perspective of caregivers and patients.

BACKGROUND: Families express a need for guidance in helping their loved ones with anorexia nervosa (AN). Guided self-help interventions can offer support to caregivers. METHODS: One hundred seventy-eight adult AN patients and their caregivers were recruited from 15 UK treatment centres. Families were randomized to carers' assessment, skills and information sharing (C) intervention + treatment as usual (TAU) or TAU alone. Feedback forms were sent at 6 months post-discharge and, if not returned, at 12 months. One hundred two (57%) patient forms (n = 50TAU; n = 52C) and 115 (65%) caregiver forms (n = 60TAU; n = 55C) were returned. Two researchers coded data blind, using thematic analysis. RESULTS: (i) Caregivers and patients express a need for post-discharge support. (ii) Patients identify helpful and unhelpful support strategies, useful for developing future interventions. (iii) Patients could identify positive caregiver behaviour changes targeted in intervention. (iv) Guided self-help may benefit caregiver and sufferer, post-discharge. CONCLUSION: Caregiver interventions can be a useful tool that will improve the cost effectiveness of inpatient treatment by enhancing the well-being of caregivers and patients.

Disseminating skills to carers of people with eating disorders: an examination of treatment fidelity in lay and professional carer coaches.

Family members of people with eating disorders (EDs) have high levels of stress and can use maladaptive methods of coping. We have developed an intervention, using motivational interviewing (MI) strategies that trains lay and professional carer coaches (CCs) to support carers of adolescents with EDs to use more adaptive coping procedures. The aim of this study is to measure treatment integrity in coaches with either academic or lived experience. Eleven coaches were trained and supervised by an expert trainer and an 'expert by experience' trainer. Six of the coaches had prior training in clinical work and/or psychology and five had personal experience of supporting a loved one with an ED. Two audio-taped sessions (Sessions 3 and 7) from each family coached (n = 22) were assessed for fidelity to MI. Half the sessions (50% n = 11) had a Motivational Interviewing Treatment Integrity global score above the suggested cut-off for recommended competency. Prior clinical training was related to higher treatment fidelity and experiential training (having coached a greater number of families) improved treatment fidelity in the lay carer group. These preliminary findings suggest that: "lay CCs" can be trained to deliver an intervention based on MI. Further exploration of a more effective means of training, monitoring and supervision is required to maximise the quality of the intervention.

Development and reliability of a Motivational Interviewing Scenarios Tool for Eating Disorders (MIST-ED) using a skills-based intervention among caregivers.

The aims of this study were to develop an eating disorder scenarios tool to assess the motivational interviewing (MI) skills of caregivers and evaluate the coding reliability of the instrument, and to test the sensitivity to change through a pre/post/follow-up design. The resulting Motivational Interview Scenarios Tool for Eating Disorders (MIST-ED) was administered to caregivers (n = 66) who were asked to provide oral and written responses before and after a skills-based intervention, and at a 3-month follow-up. Raters achieved excellent inter-rater reliability (intra-class correlations of 91.8% on MI adherent and 86.1% for MI non-adherent statements for written scenarios and 89.2%, and 85.3% for oral scenarios). Following the intervention, MI adherent statements increased (baseline = 9.4%, post = 61.5% and follow-up 47.2%) and non-MI adherent statements decreased (baseline = 90.6%, post = 38.5% and follow-up = 52.8%). This instrument can be used as a simple method to measure the acquisition of MI skills to improve coping and both response methods are adequate. The tool shows good sensitivity to improved skills.

A description of multiple family workshops for carers of people with anorexia nervosa.

Carers of people with eating disorders are uncertain about how best to help and express the need for information. Fifty per cent of carers (usually parents) exhibit clinically significant anxiety and/or depression. This may result from a difficulty coping with the manifestations of anorexia nervosa (AN) in the sufferer. In turn, eating disorder symptoms can be maintained by family reactions to the illness. Thus, carer's own symptoms, plus their uncertainty about how to help, impinge upon the AN sufferer, exacerbating their symptoms and behaviours. In this paper, we describe an intervention which uses cognitive behavioural therapy principles to alleviate carer's depression and anxiety and motivational interviewing to target behaviours that maintain eating disorder symptoms, for example high expressed emotion and poor communication. This is given in the form of an educational workshop for two families.

A practical comparison of two types of family intervention: an exploratory RCT of family day workshops and individual family work as a supplement to inpatient care for adults with anorexia nervosa.

BACKGROUND: Little is known about the outcome of involving families in the treatment of adults with anorexia nervosa. Carers of people with anorexia nervosa experience significant levels of distress. This may contribute to unhelpful behaviours which maintain the illness. AIMS: To evaluate the effectiveness and acceptability of family workshops with educational and skills-based components as compared to individual family work. METHOD: An exploratory randomised controlled trial of two forms of family intervention was conducted for inpatients with anorexia nervosa (n = 48) and their family members on a specialised unit for adults. RESULTS: In both groups, there was an improvement in patients' BMI and a reduction in carers' distress. There were no differences between groups. CONCLUSION: Preliminary findings suggest that workshop-based intervention with two families might be as effective as an individually focused family intervention. This may offer a more cost-effective intervention for this treatment-resistant group.

Expressed emotion in relatives of patients with eating disorders following skills training program.

OBJECTIVE: The first aim of this work was to examine whether high expressed emotion (EE) would be associated with psychological distress and negative appraisal of caregiving. The second aim was to examine whether could replicate the findings of (Uehara et al., Compr Psychiatr, 42, 132-138, 2001) regarding a reduction in EE in association with a psycho-educational intervention. METHOD: A prospective exploratory follow-up assessment of 47 caregivers in which EE was measured by Five Minutes Speech Sample, Experience of Caregiving Inventory and General Health Questionnaire (GHQ-12). RESULTS: High EE ratings were found in 26/47 (55%) carers at baseline. The high EE group had a higher negative aspects of caregiving (high EE = 109.8 vs. low EE = 93.7, p = 0.04). The number of carers with high-EE fell from 55% to 24% after intervention, and remained below at follow-up. The levels of distress and caregiving burden of the caregivers were also reduced. DISCUSSION: Fifty-five percent of the caregivers have high EE. High-EE relatives noted a higher caregiving burden than low-EE relatives particularly on the 'dimension of loss'. The level of EE was reduced following a skills training program.

Experience of caring for someone with anorexia nervosa: qualitative study.

BACKGROUND: Caring for someone with anorexia nervosa is distressing. AIMS: To gain a detailed understanding of carers' illness models and caregiving experiences. METHOD: Qualitative analysis and computerised text analysis were conducted on narratives written by parents as part of a family intervention at a specialist in-patient unit (20 mothers, 20 fathers). RESULTS: Themes concerned illness perceptions, impact on the family, and carers'emotional, cognitive and behavioural responses towards the illness. Parents perceived anorexia nervosa to be chronic and disabling. Carers blamed themselves as contributing to the illness and perceived themselves as helpless in promoting recovery. Mothers illustrated an intense emotional response, whereas fathers produced a more cognitive and detached account. CONCLUSIONS: Part of the distress in living with anorexia nervosa may be explained by unhelpful assumptions and maladaptive responses to the illness. Training parents in skills to manage the illness may improve outcome by reducing interpersonal maintaining factors.