Virtually delivered guided self-help for binge eating disorder and bulimia nervosa: findings from a service evaluation.

BACKGROUND: Timely intervention is beneficial to the effectiveness of eating disorder (ED) treatment, but limited capacity within ED services means that these disorders are often not treated with sufficient speed. This service evaluation extends previous research into guided self-help (GSH) for adults with bulimic spectrum EDs by assessing the feasibility, acceptability, and preliminary effectiveness of virtually delivered GSH using videoconferencing. METHOD: Patients with bulimia nervosa (BN), binge eating disorder (BED) and other specified feeding and eating disorders (OSFED) waiting for treatment in a large specialist adult ED out-patient service were offered virtually delivered GSH. The programme used an evidence-based cognitive behavioural self-help book. Individuals were supported by non-expert coaches, who delivered the eight-session programme via videoconferencing. RESULTS: One hundred and thirty patients were allocated to a GSH coach between 1 September 2020 and 30 September 2022; 106 (82%) started treatment and 78 (60%) completed treatment. Amongst completers, there were large reductions in ED behaviours and attitudinal symptoms, measured by the ED-15. The largest effect sizes for change between pre- and post-treatment were seen for binge eating episode frequency (d = -0.89) and concerns around eating (d = -1.72). Patients from minoritised ethnic groups were over-represented in the non-completer group. CONCLUSIONS: Virtually delivered GSH is feasible, acceptable and effective in reducing ED symptoms amongst those with bulimic spectrum disorders. Implementing virtually delivered GSH reduced waiting times, offering a potential solution for long waiting times for ED treatment. Further research is needed to compare GSH to other brief therapies and investigate barriers for patients from culturally diverse groups.

'My dad was like "it's your brain, what are you doing?"': Participant experiences of repetitive transcranial magnetic stimulation treatment in severe enduring anorexia nervosa.

OBJECTIVE: Repetitive transcranial magnetic stimulation (rTMS) is a promising emerging treatment for anorexia nervosa (AN). However, to date, patients' views and experiences of this treatment have not been fully explored. To assess these, we integrated a qualitative study into a feasibility randomised controlled trial of rTMS in individuals with severe enduring AN. METHOD: Twenty-nine (of 34) trial participants contributed to this study. Semi-structured interviews were conducted 3-months following the completion of rTMS treatment (4-months post-randomisation), prior to unblinding. Transcripts were analysed using content analysis. RESULTS: rTMS was deemed an acceptable but time-consuming treatment. Many emphasised how their lives had changed to some extent during, but mainly after treatment by making them more positive, open-minded, flexible and willing to try new things in relation to their AN and other aspects of their lives. CONCLUSIONS: These qualitative data will be valuable in shaping participant information, recruitment and planning of future large-scale trials of rTMS in AN. TRIAL REGISTRATION: ISRCTN14329415, registered 23rd July 2015, https://www.isrctn.com/ISRCTN14329415.

Identity Development and Social-Emotional Disorders During Adolescence and Emerging Adulthood: A Systematic Review and Meta-Analysis.

Depression, anxiety and eating disorders ("social-emotional disorders") are common during adolescence/emerging adulthood, periods of intense identity development. Despite this, there are few reviews of existing research on the relationship between symptoms of these disorders and ongoing identity development. This study systematically reviewed, narratively synthesized and meta-analyzed longitudinal investigations of the relationship between identity synthesis/confusion and depression, anxiety and eating disorders symptoms during adolescence/emerging adulthood. Three databases (PsycInfo, Medline, Embase) were searched. Study quality was systematically appraised, findings were qualitatively synthesized and (where possible) meta-analyzed. 20 studies (55% "fair" quality, 45% "poor" quality) were identified, including 13,787 participants (54.2% female, mean age = 14.48 years, range 10-29 years). The narrative synthesis found evidence of bidirectional relationships between identity synthesis/confusion and depression, anxiety and eating disorder symptoms. Meta-analyses and meta-regressions of a sub-sample of studies (N = 9) indicated no significant associations between identity synthesis or confusion and anxiety or depression symptoms. More high-quality research is needed before firm conclusions can be drawn.

Online prevention programmes for university students: stakeholder perspectives from six European countries.

BACKGROUND: Students beginning university are at a heightened risk for developing mental health disorders. Online prevention and early intervention programmes targeting mental health have the potential to reduce this risk, however, previous research has shown uptake to be rather poor. Understanding university stakeholders' (e.g. governing level and delivery staff [DS] and students) views and attitudes towards such online prevention programmes could help with their development, implementation and dissemination within university settings. METHODS: Semi-structured interviews, focus groups and online surveys were completed with staff at a governing level, university students and DS (i.e. student health or teaching staff) from six European countries. They were asked about their experiences with, and needs and attitudes towards, online prevention programmes, as well as the factors that influence the translation of these programmes into real-world settings. Results were analyzed using thematic analysis. RESULTS: Participating stakeholders knew little about online prevention programmes for university settings; however, they viewed them as acceptable. The main themes to emerge were the basic conditions and content of the programmes, the awareness and engagement, the resources needed, the usability and the responsibility and ongoing efforts to increase reach. CONCLUSIONS: Overall, although these stakeholders had little knowledge about online prevention programmes, they were open to the idea of introducing them. They could see the potential benefits that these programmes might bring to a university setting as a whole and the individual students and staff members.

Exploring the use of individualised patient-reported outcome measures in eating disorders: Validation of the Psychological Outcome Profiles.

RATIONALE: Psychotherapies for eating disorders (EDs) are routinely assessed using standardised patient-reported outcome measures (PROMs). PROMs have been criticised for their lack of patient centeredness and clinical utility. The Psychological Outcome Profiles (PSYCHLOPS) is an individualised PROM that allows patients to specify their own outcomes. AIMS: (1) To validate the use of the PSYCHLOPS in ED treatment, and (2) to identify patient concerns beyond those measured by common ED PROMs. METHODS: Two hundred and seventy-eight emerging adult patients, presenting with a first-episode ED (aged 16-25, illness duration <3 years) completed the PSYCHLOPS and two standardised ED PROMs (the EatingDisorder Examination Questionnaire [EDE-Q] and the Clinical Impairment Assessment Questionnaire [CIA]) at four time points across 12 months. Psychometrics of the PSYCHLOPS were assessed quantitatively against the EDE-Q and CIA. Content analysis assessed unique patient concerns identified by PSYCHLOPS. RESULTS: The PSYCHLOPS had adequate to good psychometric properties. A total of 53.3% of participants reported a concern not addressed by the EDE-Q or the CIA, the most common being depression/anxiety, academic problems, treatment concerns and disturbed sleep. DISCUSSION: PROMs can be complemented by the PSYCHLOPS to identify problems specific to an individual's context. As ED patients are typically ambivalent about change, understanding their concerns is vital in building motivation for change.

Approach bias modification training in bulimia nervosa and binge-eating disorder: A pilot randomized controlled trial.

OBJECTIVE: Bulimia nervosa (BN) and binge-eating disorder (BED) are associated with poorly controlled approach behavior toward food resulting in binge eating. Approach bias modification (ABM) may reduce these automatic action tendencies (i.e., approach bias) toward food and may thus decrease binge eating and related symptoms. METHOD: A total of 56 patients with BN/BED participated in this double-blind, randomized controlled trial (RCT) comparing real and sham ABM. The real ABM condition adopted an implicit learning paradigm in which participants were trained to show avoidance behavior in response to food cues. Participants in the sham condition used a similar task but were not trained to avoid food cues. Both conditions comprised 10 training sessions within 4 weeks. RESULTS: Participants in both groups experienced significant reductions in binge eating, eating disorder symptoms, trait food craving, and food cue reactivity. Real ABM tended to result in greater reductions in eating disorder symptoms than sham ABM. Food intake, approach bias, and attention bias toward food did not change. DISCUSSION: This is the first RCT on ABM in eating disorders. The findings provide limited support for the efficacy of ABM in BN/BED and pose questions regarding its active ingredients and its usefulness as a stand-alone treatment for eating disorders.

Internet-Based Interventions for Carers of Individuals With Psychiatric Disorders, Neurological Disorders, or Brain Injuries: Systematic Review.

BACKGROUND: Nonprofessional carers who provide support to an individual with a psychiatric or neurological disorder will often themselves experience symptoms of stress, anxiety, or low mood, and they perceive that they receive little support. Internet-based interventions have previously been found to be effective in the prevention and treatment of a range of mental health difficulties in carers. OBJECTIVE: This review seeks to establish the status of internet-based interventions for informal (nonprofessional) carers of people with psychiatric or neurological disorders by investigating (1) the number and quality of studies evaluating the efficacy or effectiveness of internet-based carer interventions and (2) the impact that such interventions have on carer mental health, as well as (3) how internet-based interventions compare with other intervention types (eg, face-to-face treatment). METHODS: A systematic literature search was conducted in January 2019 using the EMBASE (1974-present), Ovid MEDLINE (1946-present), PsychARTICLES, PsychINFO (1806-present), and Global Health (1973-present) databases, via the Ovid Technologies database. Search terms included carer, caregiver, online, technology, internet-based, internet, interactive, intervention, and evaluation. Studies selected for inclusion in this review met the following predetermined criteria: (1) delivering an intervention aimed primarily at informal carers, (2) carers supporting individuals with psychiatric disorders, stroke, dementia, or brain injury, (3) the intervention delivered to the carers was primarily internet based, (4) the study reported a pre- and postquantitative measure of carer depression, anxiety, stress, burden, or quality of life, (5) appeared in a peer-reviewed journal, and (6) was accessible in English. RESULTS: A total of 46 studies were identified for inclusion through the detailed search strategy. The search was conducted, and data were extracted independently by 2 researchers. The majority of studies reported that 1 or more measures relating to carer mental health improved following receipt of a relevant intervention, with interventions for carers of people with traumatic brain injury showing a consistent link with improved outcomes. CONCLUSIONS: Studies investigating internet-based interventions for carers of individuals with diverse psychiatric or neurological difficulties show some evidence in support of the effectiveness of these interventions. In addition, such interventions are acceptable to carers. Available evidence is of varying quality, and more high-quality trials are needed. Further research should also establish how specific intervention components, such as structure or interactivity, contribute to their overall efficacy with regard to carer mental health.

Students' perceptions of an online mental health intervention: a qualitative interview study.

BACKGROUND: University students are at a heightened risk of developing mental health disorders. Online interventions are becoming increasingly popular in this target group, both to prevent the development of mental health disorders and to treat existing ones. The PLUS (Personality and Living of University Students) programme is a web-based targeted prevention intervention which has been tested across two European countries. Completion of this programme has been relatively poor. Understanding university students' opinions, experiences and perceptions of the PLUS programme can lead to future improvements in intervention design, engagement and dissemination. METHODS: Semistructured interviews were conducted with university students from the UK (n = 10) and Austria (n = 14) who had previously had access to PLUS. Students were asked about their perception and experiences of the programme, and how it could be improved. Results were analysed using thematic analysis. RESULTS: Experience of online prevention programmes in general were limited and as a result of this, few had specific expectations of the PLUS programme before signing up. The lack of guidance and accountability due to the online nature of the programme made engagement challenging for many, however, frequent reminder emails helped mitigate this. In terms of positives of the programme, participants found the flexibility suitable for students and many noticed that the programme created change in how they thought or behaved. CONCLUSION: Overall, the PLUS programme was well received by students, despite study retention being poor. Although PLUS was viewed as a useful tool to integrate into the university setting, several improvements were suggested to increase engagement. By considering this feedback, uptake and intervention completion can be improved for future preventative interventions.

"I'm truly free from my eating disorder": Emerging adults' experiences of FREED, an early intervention service model and care pathway for eating disorders.

BACKGROUND: Eating disorders (EDs) typically start during adolescence or emerging adulthood, periods of intense biopsychosocial development. FREED (First Episode Rapid Early Intervention for EDs) is a service model and care pathway providing rapid access to developmentally-informed care for emerging adults with EDs. FREED is associated with reduced duration of untreated eating disorder and improved clinical outcomes, but patients' experiences of treatment have yet to be assessed. OBJECTIVE: This study aimed to assess emerging adults' experiences of receiving treatment through FREED. METHOD: This study triangulated qualitative data on participants' experiences of FREED treatment from questionnaires and semi-structured interviews. Participants were 106 emerging adults (aged 16-25; illness duration < 3 yrs) (questionnaire only = 92; interview only = 6; both = 8). Data were analysed thematically. RESULTS: Most participants reported psychological and behavioural changes over the course of treatment (e.g. reduction in symptoms; increased acceptance and understanding of difficulties). Participants identified five beneficial characteristics of FREED treatment: i) rapid access to treatment; ii) knowledgeable and concerned clinicians; iii) focusing on life beyond the eating disorder; iv) building a support network; v) becoming your own therapist. CONCLUSION: This study provides further supports for the implementation of early intervention and developmentally-informed care for EDs. Future service model development should include efforts to increase early help-seeking.

"I'm not a teenager, I'm 22. Why can't I snap out of it?": a qualitative exploration of seeking help for a first-episode eating disorder during emerging adulthood.

BACKGROUND: Eating disorders (EDs) typically have their onset during adolescence or the transition to adulthood. Emerging adulthood (~ 18-25 years) is a developmental phase which conceptually overlaps with adolescence but also has unique characteristics (e.g. increased independence). Emerging adults tend to come to ED services later in illness than adolescents, and emerging adulthood's unique characteristics may contribute to such delays. OBJECTIVE: This study aimed to explore attitudes towards ED symptoms, and their implications for help-seeking, amongst emerging adults receiving ED treatment through FREED, an early intervention care pathway. METHOD: Participants were 14 emerging adults (mean age 20.9 years; SD = 2.0), all currently receiving specialist treatment for a first-episode, recent-onset (< 3 years) ED. Semi-structured interviews relating to experiences of help-seeking were conducted, and data were analysed thematically. RESULTS: Symptom egosyntonicity, gradual reappraisal and feelings of exclusion from ED discourse were key attitudinal phases prior to help-seeking, each of which had distinct implications for help-seeking. CONCLUSIONS: Emerging adults with first-episode EDs show a distinct set of help-seeking-related challenges and opportunities (e.g. help-seeking for others; help-seeking at transitions; self-sufficiency). This research might be used to inform the development and evaluation of interventions which aim to facilitate help-seeking amongst emerging adults with first-episode recent-onset EDs.

Symptom trajectories into eating disorders: A systematic review of longitudinal, nonclinical studies in children/adolescents.

BACKGROUND: Eating disorders (EDs) are serious mental illnesses that can be life-threatening. Stage of illness models and early intervention strategies could be informed by a better understanding of symptomatology that precedes the onset of an ED. This review aims to explore which symptoms (both ED and other psychiatric disorder-related) exist prior to the onset of an ED and whether there any prospective associations between these symptomatologies. METHODS: A systematic literature review was conducted in MEDLINE, Embase, and PsycINFO for large, longitudinal, prospective studies in nonclinical cohorts of children/adolescents that report symptoms prior to the onset of an ED. A quality assessment of included studies was conducted using the Newcastle-Ottawa Quality Assessment Scale. RESULTS: A total of 22 studies were included, and over half were assessed to be of good quality. Studies identified the presence of a broad range of ED and other psychiatric disorder-related symptoms prior to ED onset. Possible prospective associations were identified, including early eating and feeding difficulties in childhood, to ED-related symptoms (e.g., dieting and body dissatisfaction) and other psychiatric disorder-related symptoms (e.g., anxiety and depression) in childhood/early adolescence, progressing to severe symptomatology (e.g., extreme weight control behaviors and self-harm) in mid-adolescence/emerging adulthood. CONCLUSION: The trajectory of symptoms identified to precede and possibly predict onset of an ED may inform early intervention strategies within the community. Suggestions for further research are provided to establish these findings and the clinical implications of these discussed, in order to inform how best to target prodromal stages of EDs.

Interpretation bias modification to reduce body dissatisfaction - a randomized controlled pilot study in women with elevated weight and shape concerns.

BACKGROUND: Recent research has identified several cognitive biases in patients with eating disorders, such as a tendency to interpret ambiguous information about one's own body in a negative way. The so-called "negative interpretation bias" is considered to be a key factor in maintaining maladaptive cognitions and behaviors in eating disorders. Studies on modification of the negative interpretation bias in eating disorders have yielded mixed results. This randomized controlled pilot study examined whether a specially adapted, computerized version of the Scrambled Sentences Task modifies negative interpretation bias in women with elevated body dissatisfaction. METHODS: The sample consisted of 40 normal-weight women with elevated body dissatisfaction, randomly assigned either to an intervention or a no-intervention control group (each n = 20). The intervention group received six sessions (within two weeks) of a newly-developed interpretation bias modification training that involved unscrambling positively valenced, body image-related sentences. The control group received no intervention. In both groups, body image-related negative interpretation bias (main outcome), trait body dissatisfaction and thin-ideal cue reactivity were assessed at baseline and two weeks later. Additionally, in the intervention condition, the trajectory of expected reductions in the thin-ideal internalization was measured during each training session. RESULTS: In both conditions, body image-related negative interpretation bias and trait body dissatisfaction decreased significantly from pre- to post-assessment; however, a specific effect imparted by the interpretation bias modification training was not found. Groups did not differ in thin-ideal cue reactivity. In the intervention group, thin-ideal internalization decreased significantly over the training sessions. CONCLUSIONS: The findings do not support use of body image-related interpretation bias modification in its current form in the treatment of body dissatisfaction. Further research involving different versions of the training and clinical samples is warranted.

Eating Disorders During Emerging Adulthood: A Systematic Scoping Review.

Background: Eating disorders (EDs) during the transition to adulthood can derail social, psychological, and vocational development. Effective treatment is of paramount importance, yet young adults' treatment needs are typically less well met than those of adolescents. In recent years, there has been a considerable shift in how developmental psychologists understand the transition to adulthood, with this life-phase reconceptualized as "emerging adulthood" (EA) (~18-25 years). Engagement with burgeoning developmental research is likely key to providing more effective care for young people experiencing EDs. Aims: To review ED research which has utilized the concept of EA, and to assess the usefulness of this concept for ED research and practice. Methods: A systematic scoping review was conducted in accordance with the Joanna Briggs Institute guidelines for scoping reviews. Three databases (Psychinfo, PubMed, Embase) were searched for papers which explicitly focused on EDs during EA. No restrictions as to publication type, language, study design, or participants were applied. Included studies were assessed for developmental "informedness," and findings were qualitatively synthesized. Results: Thirty-six studies (N = 25,475) were included in the review. Most studies used quantitative methodologies, were cross-sectional in design and focused on identifying psychological and social factors which contribute to etiology of EDs. Many studies (N = 22) used well-defined samples of emerging adults (EAs); few studies (N = 8) included developmental measures relevant to EAs. Findings indicate that whilst factors implicated in EDs in adolescence and adulthood are relevant to EAs, EA-specific factors (e.g., identity exploration) may also contribute. Conventional ED services and treatments present difficulties for EAs, whilst those adapted to EAs' needs are feasible, acceptable, and more effective than treatment-as-usual. Directions for future research and clinical implications are discussed. Conclusion: Existing research indicates that the EA concept is relevant for understanding EDs during the transition to adulthood, and ED services should implement adaptations which exploit the opportunities and overcome the challenges of this developmental stage. EA is currently an underused concept in ED research, and future engagement with the developmental literature by both researchers and clinicians may be key to understanding and treating EDs during transition to adulthood.

Using internet-based self-help to bridge waiting time for face-to-face outpatient treatment for Bulimia Nervosa, Binge Eating Disorder and related disorders: Study protocol of a randomized controlled trial.

BACKGROUND: Eating disorders are serious conditions associated with an impaired health-related quality of life and increased healthcare utilization and costs. Despite the existence of evidence-based treatments, access to treatment is often delayed due to insufficient health care resources. Internet-based self-help interventions may have the potential to successfully bridge waiting time for face-to-face outpatient treatment and, thus, contribute to overcoming treatment gaps. However, little is known about the feasibility of implementing such interventions into routine healthcare. The aim of this study is to analyze the effects and feasibility of an Internet-based self-help intervention (everyBody Plus) specifically designed for patients with Bulimia Nervosa, Binge Eating Disorder and other specified feeding and eating disorders (OSFED) on a waiting list for outpatient face-to-face treatment. The aim of this paper is to describe the study protocol. METHODS: A multi-country randomized controlled trial will be conducted in Germany and the UK. N = 275 female patients awaiting outpatient treatment will be randomly allocated either to the guided online self-help intervention "everyBody Plus" or a waitlist control group condition without access to the intervention. everyBody Plus comprises eight weekly sessions that cover topics related to eating and exercise patterns, coping with negative emotions and stress as well as improving body image. Participants will receive weekly individualized feedback based on their self-monitoring and journal entries. Assessments will take place at baseline, post-intervention as well as at 6- and 12-months follow up. In addition, all participants will be asked to monitor core eating disorder symptoms weekly to provide data on the primary outcome. The primary outcome will be number of weeks after randomization until a patient achieves a clinically relevant improvement in core symptoms (BMI, binge eating, compensatory behaviors) for the first time. Secondary outcomes include frequency of core symptoms and eating disorder related attitudes and behaviors, as well as associated psychopathology. Additional secondary outcomes will be the participating therapists' confidence in treating eating disorders as well as perceived benefits of everyBody Plus for patients. DISCUSSION: To the best of our knowledge, this is the first randomized controlled trial examining the effects of Internet-based self-help for outpatients with eating disorders awaiting face-to-face outpatient treatment. If proven to be effective and successfully implemented, Internet-based self-help programs might be used as a first step of treatment within a stepped-care approach, thus reducing burden and cost for both patients and health care providers.

Assessing the costs and cost-effectiveness of ICare internet-based interventions (protocol).

BACKGROUND: Mental health problems are common and place a burden on the individual as well as on societal resources. Despite the existence of evidence-based treatments, access to treatment is often prevented or delayed due to insufficient health care resources. Effective internet-based self-help interventions have the potential to reduce the risk for mental health problems, to successfully bridge waiting time for face-to-face treatment and to address inequities in access. However, little is known about the cost-effectiveness of such interventions. This paper describes the study protocol for the economic evaluation of the studies that form the ICare programme of internet-based interventions for the prevention and treatment of a range of mental health problems. METHODS: An overarching work package within the ICare programme was developed to assess the cost-effectiveness of the internet-based interventions alongside the clinical trials. There are two underlying tasks in the ICare economic evaluation. First, to develop schedules that generate equivalent and comparable information on use of services and supports across seven countries taking part in clinical trials of different interventions and second, to estimate unit costs for each service and support used. From these data the cost per person will be estimated by multiplying each participant's use of each service by the unit cost for that service. Additionally, productivity losses will be estimated. This individual level of cost data matches the level of outcome data used in the clinical trials. Following the analyses of service use and costs data, joint analysis of costs and outcomes will be undertaken to provide findings on the relative cost-effectiveness of the interventions, taking both a public sector and a societal perspective. These analyses use a well-established framework, the Production of Welfare approach, and standard methods and techniques underpinned by economic theory. DISCUSSION/CONCLUSION: Existing research tends to support the effectiveness of internet-based interventions, but there is little information on their cost-effectiveness compared to 'treatment as usual'. The economic evaluation of ICare interventions will add considerably to this evidence base.

A web-based intervention for carers of individuals with anorexia nervosa (We Can): Trial protocol of a randomised controlled trial investigating the effectiveness of different levels of support.

BACKGROUND: Anorexia nervosa (AN) is a life-threatening mental disorder that is associated with substantial caregiver burden. Carers of individuals with AN report high levels of distress and self-blame, and insufficient knowledge to help their loved ones. However, carers can have a very important role to play in aiding recovery from AN, and are often highly motivated to assist in the treatment process. This manuscript presents the protocol for a randomised controlled trial (RCT) of We Can, a web-based intervention for carers for people with AN. The study aims to investigate the effectiveness of We Can delivered with different intensities of support. METHODS: The study takes the form of a multi-site, two-country, three group RCT, comparing We Can (a) with clinician messaging support (We Can-Ind), (b) with moderated carer chatroom support (We Can-Chat) and (c) with online forum only (We Can-Forum). Participants will be 303 carers of individuals with AN as well as, where possible, the individuals with AN themselves. Recruitment will be via specialist eating disorder services and carer support services in the UK and Germany. Randomisation of carers to one of the three intervention conditions in a 1:1:1 ratio will be stratified by whether or not the individual with AN has (a) agreed to participate in the study and (b) is a current inpatient. The We Can intervention will be provided to carers online over a period of 12 weeks. Participants will complete self-report questionnaires at pre-intervention (T1), mid-intervention (mediators only; 4-weeks post-randomisation), post-intervention (T2; 3-months post randomisation), and 6 months (T3) and 12 months (T4) after randomisation. The primary outcome variables are carer symptoms of depression and anxiety. Secondary outcome variables will be measured in both carers and individuals with AN. Secondary carer outcome variables will include alcohol and drug use and quality of life, caregiving behaviour, and the acceptability and use of We Can and associated supports. Secondary outcomes measured in individuals with AN will include eating disorder symptoms, and symptoms of depression and anxiety. The study will also evaluate the cost-effectiveness of the three We Can conditions, and test for mediators and moderators of the effects of We Can. The trial is registered at the International Standard Randomisation Controlled Trial Number (ISRCTN) database, registration number: ISRCTN11399850. DISCUSSION: The study will provide insight into the effectiveness of We Can and its optimal method/s of delivery.

Web-based indicated prevention of common mental disorders in university students in four European countries - Study protocol for a randomised controlled trial.

BACKGROUND: Mental disorders and their symptoms are highly prevalent in the university student population, and the transition from secondary to tertiary education is associated with a rise in mental health problems. Existing web-based interventions for the prevention of common mental disorders in student populations often focus on just one disorder and have not been designed specifically for students. There is thus a need for transdiagnostic, student-specific preventative interventions that can be widely disseminated. This two-arm, parallel group randomised controlled trial aims to evaluate the effectiveness and cost-effectiveness of a web-based transdiagnostic mental health problem prevention programme (PLUS) across several universities in four countries. METHOD: Students (N = 5550) will be recruited through a variety of channels and asked to complete a personality assessment to determine whether they are at high risk for developing common mental disorders. Students at high risk will be randomly allocated to either PLUS or a control intervention, which provides practical support around issues commonly experienced at university. Students at low risk will be allocated to the control intervention. Both intervention groups will be assessed at baseline, 4 weeks, 3 months, 6 months and 12 months after randomisation. Depression and generalised anxiety, assessed using the Patient Health Questionnaire and the Generalised Anxiety Disorder scales, will form the primary outcomes in this study. Secondary outcome measures include alcohol and drug use, eating behaviour, self-esteem, and quality of life. The cost-effectiveness of the intervention will also be evaluated. CONCLUSIONS: This study will contribute to understanding the role of transdiagnostic indicated web-based interventions for the prevention of common mental disorders in university students. It will also be one of the first studies to investigate the cost-effectiveness of such interventions. TRIAL REGISTRATION: This trial was registered in the ISRCTN register (ISRCTN15570935) on 12th February 2016.