Using web-based, guided self-help to bridge the waiting time for face-to-face out-patient treatment for bulimic-spectrum disorders: randomised controlled trial.

BACKGROUND: Although effective treatments for bulimic-spectrum eating disorders exist, access is often delayed because of limited therapist availability and lengthy waiting lists. Web-based self-help interventions have the potential to bridge waiting times for face-to-face treatment and overcome existing treatment gaps. AIMS: This study aims to assess the effectiveness of a web-based guided self-help intervention (everyBody Plus) for patients with bulimia nervosa, binge eating disorder and other specified feeding and eating disorders who are waiting for out-patient treatment. METHOD: A randomised controlled trial was conducted in Germany and the UK. A total of 343 patients were randomly assigned to the intervention 'everyBody Plus' or a waitlist control condition. The primary outcome was the number of weeks after randomisation until a patient achieved a clinically relevant improvement in core symptoms for the first time. Secondary outcomes included eating disorder attitudes and behaviours, and general psychopathology. RESULTS: At 6- and 12-month follow-up, the probability of being abstinent from core symptoms was significantly larger for the intervention group compared with the control group (hazard ratio: 1.997, 95% CI 1.09-3.65; P = 0.0249). The intervention group also showed larger improvements in eating disorder attitudes and behaviours, general psychopathology, anxiety, depression and quality of life, compared with the control group at most assessment points. Working alliance ratings with the online therapist were high. CONCLUSIONS: The self-help intervention everyBody Plus, delivered with relatively standardised online guidance, can help bridge treatment gaps for patients with bulimic-spectrum eating disorders, and achieve faster and greater reductions in core symptoms.

Effectiveness of an App-Based Short Intervention to Improve Sleep: Randomized Controlled Trial.

BACKGROUND: A growing body of evidence for digital interventions to improve sleep shows promising effects. The interventions investigated so far have been primarily web-based; however, app-based interventions may reach a wider audience and be more suitable for daily use. OBJECTIVE: This study aims to evaluate the intervention effects, adherence, and acceptance of an unguided app-based intervention for individuals who wish to improve their sleep. METHODS: In a randomized controlled trial, we evaluated the effects of an app-based short intervention (Refresh) to improve sleep compared with a waitlist condition. Refresh is an 8-week unguided intervention covering the principles of cognitive behavioral therapy for insomnia (CBT-I) and including a sleep diary. The primary outcome was sleep quality (insomnia symptoms) as self-assessed by the Regensburg Insomnia Scale (RIS). The secondary outcomes were depression (9-item Patient Health Questionnaire [PHQ-9] score) and perceived insomnia-related impairment. RESULTS: We included 371 participants, of which 245 reported poor sleep at baseline. About 1 in 3 participants who were allocated to the intervention group never accessed the intervention. Active participants completed on average 4 out of 8 chapters. Retention rates were 67.4% (n=250) at postassessment and 57.7% (n=214) at the 6-month follow-up. At postintervention, insomnia symptoms in the intervention group had improved more than those in the waitlist group, with a small effect (d=0.26) in the whole sample and a medium effect (d=0.45) in the subgroup with poor sleep. Effects in the intervention group were maintained at follow-up. Perceived insomnia-related impairment also improved from pre- to postassessment. No significant intervention effect on depression was detected. Working alliance and acceptance were moderate to good. CONCLUSIONS: An app-based, unguided intervention is a feasible and effective option to scale-up CBT-I-based treatment, but intervention uptake and adherence need to be carefully addressed. TRIAL REGISTRATION: ISRCTN Registry ISRCTN53553517; https://www.isrctn.com/ISRCTN53553517.

Indicated Web-Based Prevention for Women With Anorexia Nervosa Symptoms: Randomized Controlled Efficacy Trial.

BACKGROUND: Although preventive interventions for eating disorders in general have shown promise, interventions specifically targeting individuals at risk for anorexia nervosa (AN) are lacking. OBJECTIVE: The aim of this study was to determine the efficacy of a guided, indicated web-based prevention program for women at risk for AN. METHODS: We conducted a randomized controlled efficacy trial for women at risk for AN. Assessments were carried out at baseline (before the intervention), after the intervention (10 weeks after baseline), and at 6- and 12-month follow-ups (FUs). A total of 168 women with low body weight (17.5 kg/m2≤BMI≤19 kg/m2) and high weight concerns or with normal body weight (19 kg/m2

Stakeholders' perspectives on online interventions to improve mental health in eating disorder patients and carers in Germany.

BACKGROUND: Eating disorders are causing severe consequences for those affected as well as a high burden for their carers. Although there is a substantial need for psychological assistance, different factors are hindering access to support. Internet-based interventions can help to overcome these barriers. To date, there is only little knowledge on attitudes of potential users, facilitators (e.g. psychologists) and decision makers (e.g. health insurances) regarding these interventions. METHODS: We conducted focus groups with potential users (N = 30) and semi-structured interviews with potential decision makers (N = 4). Potential facilitators (N = 41) participated in an online survey. Stakeholders' experiences, attitudes, and their needs regarding Internet-based interventions for eating disorder patients and carers were assessed. Furthermore, hindering and fostering factors related to reach, adoption, implementation and maintenance were analyzed. RESULTS: About two-thirds of the participating facilitators have heard or read about Internet-based interventions in general. In contrast, the other stakeholders mentioned to have no or little experience with such interventions. Factors like anonymity, availability and cost-effectiveness were seen as major advantages. Also disadvantages, e.g. lack of personal contact, limitations by disease severity and concerns on data safety, were mentioned. Stakeholders stated the need for interventions which are usable, evidence-based, tailored and provide personal support. CONCLUSION: Stakeholders considered Internet-based programmes to have more advantages than disadvantages. Effort should be put in providing systematic education to address prejudices. When offering an online intervention, stakeholders' needs, as well as a continuous evaluation and adaptation, have to be taken into account.

Stakeholders' views on online interventions to prevent common mental health disorders in adults implemented into existing healthcare systems in Europe.

BACKGROUND: Online preventive interventions can help to reduce the incidence of mental disorders. Whereas knowledge on stakeholders' attitudes and factors relevant for successfully integrating online treatment into existing healthcare systems is available, knowledge is scarce for online prevention. METHODS: Stakeholders from Germany, Switzerland, Austria and Spain were surveyed. Potential facilitators/delivery staff (e.g. psychologists, psychotherapists) completed an online questionnaire (n = 183), policy makers (i.e. from the governing sector or health insurance providers) participated in semi-structured interviews (n = 16) and target groups/potential users of mental illness prevention (n = 49) participated in ten focus groups. Thematic analysis was used to identify their experiences with and attitudes and needs regarding online programmes to prevent mental disorders. Additionally, it was examined which groups they consider underserved and which factors they consider as fostering and hindering for reach, adoption, implementation and maintenance (cf. RE-AIM model) when integrating online prevention into existing healthcare systems. RESULTS: Main advantages of online mental illness prevention are perceived in low structural and psychological barriers. Lack of personal contact, security, privacy and trust concerns were discussed as disadvantages. Relevant needs are high usability and target group appropriateness, evidence for effectiveness and the use of motivational tools. CONCLUSIONS: Positive attitudes among stakeholders are the key for successful integration of online mental illness prevention into existing healthcare systems. Potential facilitators/delivery staff must receive training and support to implement these programmes; the programmes must be attractive and continuously evaluated, updated and promoted to ensure ongoing reach; and existing infrastructure and contextual factors must be considered.

Recruiting participants to an Internet-based eating disorder prevention trial: Impact of the recruitment strategy on symptom severity and program utilization.

OBJECTIVE: Using data from a randomized controlled trial, we examined two different strategies to recruit participants for an indicated preventive intervention (StudentBodies-AN) for women at risk for anorexia nervosa and compared symptom severity and program utilization in participants recruited through each strategy. METHOD: We recruited participants by announcing the study (a) in lectures at universities and handing out screening questionnaires (face-to-face recruitment) and (b) through different media channels, and the participants completed the screening questionnaire on our study website (media-based recruitment). We compared symptom severity and program utilization between the two groups. RESULTS: A total of 4,646 women (face-to-face: 3,741, media-based: 905) were screened and 168 women (face-to-face: 114, media-based: 54) were randomized to the intervention. We found a statistically and clinically significant association between recruitment strategy and symptom severity: Participants who were recruited through media were more likely to fulfill the inclusion criteria (40.6% vs. 13.3%; p < .001) and endorsed significantly more frequently core behaviors and attitudes of disordered eating (EDE global score: 2.72 vs. 2.17, p < .05; Weight Concerns Scale [WCS] score: 66.05 vs. 56.40, p < .05) at baseline than participants recruited face-to-face. Also, participants recruited through media were more likely to log onto the program (χ2 = 5.06; p = .029) and accessed more of the intervention. DISCUSSION: Recruitment through media seems both more feasible and suitable to reach individuals in need of indicative prevention, and should be part of a multimodal recruitment package. Future studies should be explicitly designed to investigate the impact of recruitment modality on reach and effectiveness including cost-effectiveness analyses.

Adherence Reporting in Randomized Controlled Trials Examining Manualized Multisession Online Interventions: Systematic Review of Practices and Proposal for Reporting Standards.

BACKGROUND: Adherence reflects the extent to which individuals experience or engage with the content of online interventions and poses a major challenge. Neglecting to examine and report adherence and its relation to outcomes can compromise the interpretation of research findings. OBJECTIVE: The aim of this systematic review is to analyze how adherence is accounted for in publications and to propose standards for measuring and reporting adherence to online interventions. METHODS: We performed a systematic review of randomized controlled trials on online interventions for the prevention and treatment of common mental disorders (depression, anxiety disorders, substance related disorders, and eating disorders) published between January 2006 and May 2018 and indexed in Medline and Web of Science. We included primary publications on manualized online treatments (more than 1 session and successive access to content) and examined how adherence was reported in these publications. RESULTS: We identified 216 publications that met our inclusion criteria. Adherence was addressed in 85% of full-text manuscripts, but only in 31% of abstracts. A median of three usage metrics were reported; the most frequently reported usage metric (61%) was intervention completion. Manuscripts published in specialized electronic health journals more frequently included information on the relation of adherence and outcomes. CONCLUSIONS: We found substantial variety in the reporting of adherence and the usage metrics used to operationalize adherence. This limits the comparability of results and impedes the integration of findings from different studies. Based on our findings, we propose reporting standards for future publications on online interventions.

Promoting positive body image and intuitive eating in women with overweight and obesity via an online intervention: Results from a pilot feasibility study.

BACKGROUND: Body dissatisfaction and dietary restraint are established risk factors for eating disorders and are also prevalent in individuals who are overweight and obese. Studies have shown that online prevention programs can lower these risk factors. The aim of this feasibility pilot study was to estimate effects of a 12-week online health promotion and eating disorder prevention program in a sample of women with overweight or obesity, but without binge eating. METHODS: The program was evaluated in an uncontrolled pre-post-follow-upstudy over 12 months. Outcome measures were eating disorder related cognitions and attitudes. Participants were recruited via flyers, online posts, press releases, and mailings through cooperating health insurances. RESULTS: 371 women who completed the screening met the inclusion criteria. 323 women took part in the baseline assessment and were granted access to the intervention. 50 women completed all sessions. An intention-to-treat analysis showed significant and long-term reductions in weight and shape concerns, restrictive eating and increases in life satisfaction and self-esteem (d = 0.31-0.86), and a short-term increase in fruit and vegetable consumption (d = 0.70). CONCLUSION: everyBody fit seems a feasible program for improving body image and reducing disordered eating in overweight and obese women, with medium to large effects on various outcomes. The efficacy of the intervention needs to be established in a randomized controlled trial.

everyBody-Tailored online health promotion and eating disorder prevention for women: Study protocol of a dissemination trial.

BACKGROUND: Although there is extensive evidence for the efficacy of online eating disorder (ED) prevention programs in clinical trials, these programs have rarely been adopted beyond the trial phase and offered to a wider audience. As risk factors for eating disorders are partly associated with overweight and overweight in turn is correlated to disordered eating, this study will offer a combined eating disorder prevention program which also promotes a balanced lifestyle to normal weight and overweight individuals alike. The efficacy of the program has been proven in previous trials. The study aims to evaluate the dissemination of a combined eating disorder prevention and health promotion program (everyBody) to women of all age groups and varying levels of ED risk status in the general population. METHODS: A dissemination trial will be conducted in German-speaking countries, including 4160 women from the general population. Participants will be screened to exclude participants who are likely to have an ED. Eligible participants will be allocated to one of five program arms based on their BMI and respective ED symptoms. The guided program consists of 4 to 12 weeks of weekly sessions offering CBT-based exercises, psychoeducational material, self-monitoring, and group discussions. Outcomes will be assessed according to the RE-AIM model, including measures of effectiveness, reach, adoption, implementation, and maintenance of the program. DISCUSSION/CONCLUSIONS: This trial aims to disseminate a combined ED prevention and health promotion program in the general population, offering universal, selective and indicated prevention in one program. To our knowledge, it is the first trial to systematically evaluate dissemination efforts based on the RE-AIM model. This trial will be conducted as part of the EU-funded ICare (Integrating Technology into Mental Health Care Delivery in Europe) project.

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.

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.

The Role of Extrinsic Rewards and Cue-Intention Association in Prospective Memory in Young Children.

The current study examined, for the first time, the effect of cue-intention association, as well as the effects of promised extrinsic rewards, on prospective memory in young children, aged 5-years-old (n = 39) and 7-years-old (n = 40). Children were asked to name pictures for a toy mole, whilst also having to remember to respond differently to certain target pictures (prospective memory task). The level to which the target picture was associated with the intention was manipulated across two conditions (low- or high-association) for all participants, whilst half of the participants were promised a reward for good prospective memory performance. Results showed a main effect of age, with the 7-year-olds outperforming the 5-year-olds. Furthermore, there was a main effect of reward, with those promised a reward performing better than those who were not. No effect was found for cue-association, with the participants of both age groups performing equally well in both association conditions. No significant interactions were found between any of the variables. The potentially important role of reward in young children's everyday prospective memory tasks, and possible reasons for the lack of a reflexive-associative effect, are discussed.