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.

Combining day treatment and outpatient treatment for eating disorders: findings from a naturalistic setting.

BACKGROUND: Day treatment programs for individuals with eating disorders (ED) have been the subject of research and are promoted as an alternative to inpatient treatment due to their therapeutic and economic advantages, but have not regularly been implemented in regular care. PURPOSE: We investigated the long-term effectiveness of a transdiagnostic combined eating disorder treatment program which consisted of an 8-week day treatment phase followed by an average of 19 sessions of outpatient treatment over an average of 39 weeks in a naturalistic setting. METHODS: We accepted 148 patients with different diagnoses of eating disorders into our combined treatment program. We assessed weight, behavioral eating disorder symptoms and eating disorder related cognitions and attitudes at the beginning and the end of the day treatment phase and after 6, 12 and 26 months. RESULTS: Over the course of the 8-week day treatment phase, patients with initial binge eating, purging and/or fasting behavior reduced these symptoms by 91%, 90% and, 86%. Patients who were underweight at baseline gained on average 1.05 BMI points (d = 0.76). In addition, eating disorder related cognitions and attitudes of all patients significantly improved with large effect sizes (d = 1.12). On average, all improvements remained stable during the follow-up period. CONCLUSIONS: Our findings add to the existing studies on day treatment and support previously found encouraging effects of treatment programs that combine day treatment and consecutive outpatient treatment for eating disorders. LEVEL OF EVIDENCE: Level III, longitudinal cohort study.

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.

Are we overdosing treatment? Secondary findings from a study following women with bulimia nervosa after inpatient treatment.

OBJECTIVE: Provision of eating disorder (ED) treatment in practice is often guided by national health service structures rather than evidence-based treatment recommendations. Especially for more severely or chronically ill patients, clinicians seem to advocate a "the more the better" strategy of treatment provision. Exploring the dose-response relationship in ED treatment may shed light on both beneficial and detrimental effects of prolonged treatment provision. METHOD: We utilized data from 64 women from the treatment-as-usual (TAU) group of a randomized controlled trial on Internet-based aftercare for women with bulimia nervosa who had received inpatient treatment. We examined the relationship between treatment duration and dose and (1) baseline patient characteristics and (2) treatment outcomes (abstinence from binge eating and compensatory behaviors, frequency of binge eating and vomiting, thin ideal internalization, and general psychopathology) at 18-month follow up. RESULTS: On average, the women in our study were hospitalized for 9 weeks and most received high doses of subsequent outpatient psychotherapy (median: 45 sessions). The severity of symptoms that a patient experienced at hospital admission or discharge was largely unrelated to the amount of outpatient treatment she subsequently received. Longer inpatient treatments or higher doses of subsequent outpatient treatment did not result in more favorable outcomes. DISCUSSION: Our findings suggest that, instead of providing costly long treatment without evidenced benefit to patients, there is a need for further exploration of and discussion about the risks and benefits of providing high doses of treatment for both individuals and the health care system.

Web-Based Aftercare for Women With Bulimia Nervosa Following Inpatient Treatment: Randomized Controlled Efficacy Trial.

BACKGROUND: Relapse rates in bulimia nervosa (BN) are high even after successful treatment, but patients often hesitate to take up further treatment. An easily accessible program might help maintain treatment gains. Encouraged by the effects of Web-based eating disorder prevention programs, we developed a manualized, Web-based aftercare program (IN@) for women with BN following inpatient treatment. OBJECTIVE: The objective of this study was to determine the efficacy of the web-based guided, 9-month, cognitive-behavioral aftercare program IN@ for women with BN following inpatient treatment. METHODS: We conducted a randomized controlled efficacy trial in 253 women with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) BN and compared the results of IN@ with treatment as usual (TAU). Assessments were carried out at hospital admission (T0), hospital discharge/baseline (T1), postintervention (T2; 9 months after baseline), 9-month follow-up (T3; 18 months after baseline). The primary outcome, abstinence from binge eating and compensatory behaviors during the 2 months preceding T2, was analyzed by intention to treat, using logistic regression analyses. Frequencies of binge eating and vomiting episodes, and episodes of all compensatory behaviors were analyzed using mixed effects models. RESULTS: At T2, data from 167 women were available. There were no significant differences in abstinence rates between the TAU group (n=24, 18.9%) and the IN@ group (n=27, 21.4%; odds ratio, OR=1.29; P=.44). The frequency of vomiting episodes in the IN@ group was significantly (46%) lower than in the TAU group (P=.003). Moderator analyses revealed that both at T2 and T3, women of the intervention group who still reported binge eating and compensatory behaviors after inpatient treatment benefited from IN@, whereas women who were already abstinent after the inpatient treatment did not (P=.004; P=.002). Additional treatment utilization was high in both groups between baseline and follow-up. CONCLUSIONS: Overall, data from this study suggest moderate effects of IN@. High rates of outpatient treatment utilization after inpatient treatment may have obscured potential intervention effects on abstinence. An aftercare intervention might be more beneficial as part of a stepped-care approach. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 08870215; http://www.isrctn.com/ISRCTN08870215 (Archived by WebCite at http://www.webcitation.org/6soA5bIit).

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.

Examining the role of personality functioning in a hierarchical taxonomy of psychopathology using two years of ambulatory assessed data.

The Hierarchical Taxonomy of Psychopathology (HiTOP) arranges phenotypes of mental disorders based on empirical covariation, ranging from narrowly defined symptoms to higher-order spectra of psychopathology. Since the introduction of personality functioning (PF) in DSM-5 and ICD-11, several studies have identified PF as a predictor of transdiagnostic aspects of psychopathology. However, the role of PF in the HiTOP classification system has not been systematically examined. This study investigates how PF can be integrated into HiTOP, whether PF accounts for transdiagnostic variance captured in higher-order spectra, and how its predictive value for future affective well-being (AWB) and psychosocial impairment (PSI) compares to the predictive value of specific psychopathology beyond PF. To this end, we examined two years of ambulatory assessed data on psychopathology, PF, PSI, and AWB of N = 27,173 users of a mental health app. Results of bass-ackwards analyses largely aligned with the current HiTOP working model. Using bifactor modeling, aspects of PF were identified to capture most of the internalizing, thought disorder, and externalizing higher-order factor variance. In longitudinal prediction analyses employing bifactor-(S-1) modeling, PF explained 58.6% and 30.6% of variance in PSI and AWB when assessed across one year, respectively, and 33.1% and 23.2% of variance when assessed across two years. Results indicate that personality functioning may largely account for transdiagnostic variance captured in the higher-order components in HiTOP as well as longitudinal outcomes of PSI and AWB. Clinicians and their patients may benefit from assessing PF aspects such as identity problems or internal relationship models in a broad range of mental disorders. Further, incorporating measures of PF may advance research in biological psychiatry by providing empirically sound phenotypes.

Effects of a Self-Guided Transdiagnostic Smartphone App on Patient Empowerment and Mental Health: Randomized Controlled Trial.

BACKGROUND: Mental disorders impact both individuals and health systems. Symptoms and syndromes often remain undetected and untreated, resulting in chronification. Besides limited health care resources, within-person barriers such as the lack of trust in professionals, the fear of stigmatization, or the desire to cope with problems without professional help contribute to the treatment gap. Self-guided mental health apps may support treatment seeking by reducing within-person barriers and facilitating mental health literacy. Digital mental health interventions may also improve mental health related self-management skills and contribute to symptom reduction and the improvement of quality of life. OBJECTIVE: This study aims to investigate the effects of a self-guided transdiagnostic app for mental health on help seeking, reduced stigma, mental health literacy, self-management skills, mental health symptoms, and quality of life using a randomized controlled design. METHODS: Overall, 1045 participants (recruited via open, blinded, and web-based recruitment) with mild to moderate depression or anxiety-, sleep-, eating-, or somatization-related psychopathology were randomized to receive either access to a self-guided transdiagnostic mental health app (MindDoc) in addition to care as usual or care as usual only. The core features of the app were regular self-monitoring, automated feedback, and psychological courses and exercises. The coprimary outcomes were mental health literacy, mental health-related patient empowerment and self-management skills (MHPSS), attitudes toward help seeking, and actual mental health service use. The secondary outcomes were psychopathological symptom burden and quality of life. Data were collected at baseline and 8 weeks and 6 months after randomization. Treatment effects were investigated using analyses of covariance, including baseline variables as predictors and applying multiple imputation. RESULTS: We found small but robust between-group effects for MHPSS (Cohen d=0.29), symptoms burden (Cohen d=0.28), and quality of life (Cohen d=0.19) 8 weeks after randomization. The effects on MHPSS were maintained at follow-up. Follow-up assessments also showed robust effects on mental health literacy and preliminary evidence for the improvement of help seeking. Predictors of attrition were lower age and higher personality dysfunction. Among the non-attritors, predictors for deterioration were less outpatient treatment and higher initial symptom severity. CONCLUSIONS: A self-guided transdiagnostic mental health app can contribute to lasting improvements in patient empowerment. Symptoms of common mental disorders and quality of life improved faster in the intervention group than in the control group. Therefore, such interventions may support individuals with symptoms of 1 or more internalizing disorders, develop health-centered coping skills, prevent chronification, and accelerate symptom improvement. Although the effects for individual users are small and predictors of attrition and deterioration need to be investigated further, the potential public health impact of a self-guided intervention can be large, given its high scalability. TRIAL REGISTRATION: German Clinical Trials Register DRKS00022531; https://drks.de/search/de/trial/DRKS00022531.

Improving Mild to Moderate Depression With an App-Based Self-Guided Intervention: Protocol for a Randomized Controlled Trial.

BACKGROUND: Depression is one of the most prevalent mental disorders and frequently co-occurs with other mental disorders. Despite the high direct and indirect costs to both individuals and society, more than 80% of those diagnosed with depression remain with their primary care physician and do not receive specialized treatment. Self-guided digital interventions have been shown to improve depression and, due to their scalability, have a large potential public health impact. Current digital interventions often focus on specific disorders, while recent research suggests that transdiagnostic approaches are more suitable. OBJECTIVE: This paper presents the protocol for a study that aims to assess the efficacy of a self-guided transdiagnostic app-based self-management intervention in patients with mild or moderate depression with and without comorbid mental disorders. Specifically, we are investigating the impact of the intervention on symptoms of depression, quality of life, anxiety symptoms, and mental health-related patient empowerment and self-management skills. METHODS: The intervention under investigation, MindDoc with Prescription, is a self-guided digital intervention aimed at supporting individuals with mild to moderate mental disorders from the internalizing spectrum, including depression. The app can be used as a low-threshold psychosocial intervention. Up to 570 adult patients will be randomized to either receive the intervention in addition to care as usual or only care as usual. We are including adults with a permanent residency in Germany and mild or moderate depression according to International Classification of Diseases, 10th Revision, criteria (F32.0, F32.1, F33.0, and F33.1). Clinical interviews will be conducted to confirm the diagnosis. Data will be collected at baseline as well as 8 weeks and 6 months after randomization. The primary outcome will be depression symptom severity after 8 weeks. Secondary outcomes will be quality of life, anxiety symptom severity, and patient empowerment and self-management behaviors. Data will be analyzed using multiple imputations, using the intention-to-treat principle, while sensitivity analyses will be based on additional imputation strategies and a per-protocol analysis. RESULTS: Recruitment for the trial started on February 7, 2023, and the first participant was randomized on February 14, 2023. As of September 5, 2023, 275 participants have been included in the trial and 176 have provided the primary outcome. The rate of missing values in the primary outcome is approximately 20%. CONCLUSIONS: Data from this efficacy trial will be used to establish whether access to the intervention is associated with an improvement in depression symptoms in individuals diagnosed with mild or moderate depression. The study will contribute to expanding the evidence base on transdiagnostic digital interventions. TRIAL REGISTRATION: German Registry of Clinical Trials DRKS00030852; https://drks.de/search/de/trial/DRKS00030852. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46651.

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.

Effects of an Internet-based prevention programme for eating disorders in the USA and Germany--a meta-analytic review.

A cross-cultural comparison of a cognitive-behavioural, Internet-based, 8-week prevention programme for eating disorders (StudentBodies™) evaluated in the USA and in Germany was performed. Six US and four German randomized controlled trials with a total (N) of 990 female high school and college students were included in the review. Two of the US and two of the German trials explicitly addressed high risk samples in a selective prevention approach. Effect sizes for main outcomes (disordered eating, weight and shape concerns) were calculated at postintervention and at follow-up. The intervention was associated with moderate improvements in eating disorder-related attitudes, especially reductions of negative body image and the desire to be thin. The reported effects remained significant at follow-up. No clear differences between US and German samples could be found on any of the outcome measures at postintervention. In conclusion, StudentBodies™ seems equally suitable and effective for American and German students.

Adding an App-Based Intervention to the Cognitive Behavioral Analysis System of Psychotherapy in Routine Outpatient Psychotherapy Treatment: Proof-of-Concept Study.

BACKGROUND: The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is an empirically supported psychotherapeutic treatment developed specifically for persistent depressive disorder. However, given the high rates of nonresponse and relapse, there is a need for optimization. Studies suggest that outcomes can be improved by increasing the treatment dose via, for example, the continuous web-based application of therapy strategies between sessions. The strong emphasis in CBASP on the therapeutic relationship, combined with limited therapeutic availabilities, encourages the addition of web-based interventions to face-to-face therapy in terms of blended therapy. OBJECTIVE: The aim of this study was to test an app-based intervention called CBASPath, which was designed to be used as a blended therapy tool. CBASPath offers 8 sequential modules with app-based exercises to facilitate additional engagement with the therapy content and a separate exercise to conduct situational analyses within the app at any time. METHODS: CBASPath was tested in an open pilot study as part of routine outpatient CBASP treatment. Participating patients were asked to report their use patterns and blended use (integrated use of the app as part of therapy sessions) at 3 assessment points over the 6-month test period and rate the usability and quality of and their satisfaction with CBASPath. RESULTS: The results of the pilot trial showed that 93% (12/13) of participants used CBASPath as a blended tool during their therapy and maintained this throughout the study period. Overall, they reported good usability and quality ratings along with high user satisfaction. All participants showed favorable engagement with CBASPath; however, the frequency of use differed widely among the participants and assessment points. Situational analysis was used by all participants, and the number of completed modules ranged from 1 to 7. All participants reported blended use, although the frequency of integration in the face-to-face sessions varied widely. CONCLUSIONS: Our findings suggest that the digital augmentation of complex and highly interactive CBASP therapy in the form of blended therapy with CBASPath is feasible in routine outpatient care. Therapeutic guidance might contribute to high adherence and increase patient self-management. A few adjustments, such as saving entries directly in the app, could facilitate higher user engagement. A randomized controlled trial is now needed to investigate the efficacy and added value of this blended approach. In the long term, CBASPath could help optimize persistent depressive disorder treatment and reduce relapse by intensifying therapy and providing long-term patient support through the app.

Does app-based unguided self-management improve mental health literacy, patient empowerment and access to care for people with mental health impairments? Study protocol for a randomised controlled trial.

INTRODUCTION: Mental disorders pose a huge burden to both individuals and health systems. Symptoms and syndromes often remain undetected and untreated, resulting in comorbidity and chronification. Besides limited resources in healthcare systems, the treatment-gap is-to a large extent-caused by within-person barriers impeding early treatment seeking. These barriers include a lack of trust in professionals, fear of stigmatisation, or the desire to cope with problems without professional help. While unguided self-management interventions are not designed to replace psychotherapy, they may support early symptom assessment and recognition by reducing within-person barriers. Digital self-management solutions may also reduce inequalities in access to care due to external factors such as regional unavailability of services. METHODS AND ANALYSIS: Approximately 1100 patients suffering from mild to moderate depressive, anxiety, sleep, eating or somatisation-related mental disorders will be randomised to receive either a low-threshold unguided digital self-management tool in the form of a transdiagnostic mental health app or care as usual. The primary outcomes will be mental health literacy, patient empowerment and access to care while secondary outcomes will be symptom distress and quality of life. Additional moderator and predictor variables are negative life events, personality functioning, client satisfaction, mental healthcare service use and application of self-management strategies. Data will be collected at baseline as well as 8 weeks and 6 months after randomisation. Data will be analysed using multiple imputation and analysis of covariance employing the intention-to-treat principle, while sensitivity analyses will be based on different multiple imputation parameters and a per-protocol analysis. ETHICS AND DISSEMINATION: Approval was obtained from the Ethics Committee of the Faculty of Educational Science and Psychology at the Freie Universität Berlin. The results will be submitted to peer-reviewed specialised journals and presented at national and international conferences. TRIAL REGISTERATION: The trial has been registered in the DRKS trial register (DRKS00022531);Pre-results.

Impact of telephone prompts on the adherence to an Internet-based aftercare program for women with bulimia nervosa: A secondary analysis of data from a randomized controlled trial.

INTRODUCTION: Poor adherence is a common challenge in self-directed mental health interventions. Research findings indicate that telephone prompts may be useful to increase adherence. METHOD: Due to poor adherence in a randomized controlled trial evaluating an Internet-based aftercare program for women with bulimia nervosa we implemented regular short telephone prompts into the study protocol halfway through the trial period. Of the 126 women in the intervention group, the first 63 women were not prompted by telephone (unprompted group) and compared with 63 women who subsequently enrolled into the study and were attempted to prompt bimonthly by a research assistant (telephone prompt group). Completed telephone calls took less than 5 min and did not include any symptom-related counseling. RESULTS: Most of the women in the telephone prompt group (67%) were reached only once or twice during the intervention period. However, overall adherence in the telephone prompt group was significantly higher than in the unprompted group (T = - 3.015, df = 124, p = 0.003). CONCLUSION: Our findings from this secondary analysis suggest that telephone prompts can positively affect adherence to an Internet-based aftercare intervention directed at patients with bulimia nervosa.

Internet-based aftercare for women with bulimia nervosa following inpatient treatment: The role of adherence.

Facing poor long-term outcome and high relapse rates in the treatment of bulimia nervosa, we developed an Internet-based aftercare program for women with severe and chronic bulimia nervosa following inpatient treatment based on previous experiences with self-directed targeted prevention and early intervention programs delivered online. The aim of the present study was to examine adherence to the program in detail, to explore potential variables that predict adherence and to analyze whether adherence affects outcomes. We analyzed data from 126 women in the intervention group of a randomized controlled trial. 107 women (85%) logged on to the program platform at least once. These women opened on average 42.8% (SD = 31.9%) of all assigned program pages. Adherence declined during the course of the intervention. Adherence was not associated with the number of outpatient treatment sessions received during the intervention period. Adherence was not related to overall illness severity or duration at baseline. However, excessive exercise at hospital discharge (which may be a sign of insufficient motivation to change eating disorder related behaviors) seems to play some small role in adherence. Adherence did not affect intervention outcomes. Based on our findings, we would like to advocate further research on online aftercare interventions for women with severe and chronic bulimia nervosa.

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.

Interrelations between participant and intervention characteristics, process variables and outcomes in online interventions: A protocol for overarching analyses within and across seven clinical trials in ICare.

BACKGROUND: It is well known that web-based interventions can be effective treatments for various conditions. Less is known about predictors, moderators, and mediators of outcome and especially interrelations between participant and interventions characteristics, process variables and outcomes in online interventions. Clinical trials often lack statistical power to detect variables that affect intervention effects and their interrelations. Within ICare, we can investigate the interrelation of potential predictor and process variables in a large sample. METHOD: The ICare consortium postulated a model of interrelations between participant and intervention characteristics, process variables and outcomes in online interventions. We will assess general and disorder-specific interrelations between characteristics of the intervention, characteristics of the participants, adherence, working alliance, early response, and intervention outcomes in a sample of over 7500 participants from seven clinical trials evaluating 15 online interventions addressing a range of mental health conditions and disorders, using an individual participant data meta-analyses approach. DISCUSSION/CONCLUSION: Existing research tends to support the efficacy of online mental health interventions, but the knowledge base regarding factors that affect intervention effects needs to be expanded. The overarching analyses using data from the ICare intervention trials will add considerably to the evidence.