Use of tailoring features and reasons for dropout in a guided internet-based transdiagnostic individually-tailored cognitive behavioral therapy for symptoms of depression and/or anxiety in college students.

Transdiagnostic individually-tailored digital interventions reduce symptoms of depression and anxiety in adults with moderate effects. However, research into these approaches for college students is scarce and contradicting. In addition, the exact reasons for intervention dropout in this target group are not well known, and the use of individually-tailored intervention features, such as optional modules, has not yet been explored. The current study aimed to (1) investigate reasons for dropout from a guided internet-based transdiagnostic individually-tailored intervention for college students assessed in a randomized controlled trial (RCT) and (2) evaluate whether participants used tailoring features intended for their baseline symptoms. A sample of college students with mild to moderate depression and/or anxiety symptoms (n = 48) in the Netherlands (partially) followed a guided internet-based transdiagnostic individually-tailored intervention. We contacted those who did not complete the entire intervention (n = 29) by phone to report the reasons for intervention dropout. Further, we descriptively explored the use of tailoring features (i.e., depression versus anxiety trajectory) and optional modules of the intervention in the whole sample. We identified a range of person- and intervention-related reasons for intervention dropout, most commonly busy schedules, needs for different kinds of help, or absence of personal contact. Furthermore, only less than half of the participants used the individually-tailoring features to address the symptoms they reported as predominant. In conclusion, digital interventions clear about the content and targeted symptoms, tested in user research could prevent dropout and create reasonable expectations of the intervention. Participants would benefit from additional guidance when using tailoring features of digital interventions, as they often do not choose the tailoring features targeting their baseline symptoms.

Depression and Anxiety in Adolescents and their Caregivers: A Cross-Sectional Study from North Macedonia.

Introduction: Mental health problems have increased internationally during the COVID-19 pandemic. Adolescents and their caregivers form a vulnerable group for the development of mental health problems. However, most data stems from high-income countries, and there is a clear lack of prevalence rates and potential risk factors from Balkan countries. No data is available on the impact of the COVID-19 pandemic on mental health in adolescents and their caregivers in North Macedonia. Materials and methods: A cross-sectional study was conducted on adolescents and their caregivers in a school setting in rural and urban areas of North Macedonia. Survey items assessed symptoms of depression, anxiety, and respondents' fear of COVID-19, as well as a number of risk factors, such as gender and living environment. Results: 506 adolescents and 492 caregivers completed the survey. Symptoms of depression and anxiety were mild to moderate in adolescents and their caregivers. Women and girls generally scored higher than men and boys, and adolescents in high school scored higher than those in elementary school. Prevalence rates for depression were 29.2% for adolescents and 10.4% for caregivers, while rates of anxiety were 23.7% for adolescents and 6.1% for caregivers. Conclusion: This study provides a first insight into the mental health of adolescents and their caregivers after the COVID-19 pandemic in North Macedonia. Further research is required to investigate the relatively low rates of caregivers' mental health problems compared to data from other countries.

The impact of the COVID-19 pandemic and earthquake on mental health of persons with severe mental illness: A survey study among people receiving community mental health care versus treatment as usual in Croatia.

BACKGROUND: The COVID-19 pandemic led to the disruption of mental health services in most countries. Croatia has been developing and strengthening its mental health system, including the introduction of community mental health teams (CMHT) for persons with severe mental illness (SMI), whose implementation was ongoing during the pandemic through the RECOVER-E project. AIMS: The aim of this study was to assess the differences in mental health outcomes, perceived social support and healthcare utilization in the group of participants receiving treatment as usual (TAU group) compared to the group receiving TAU and additional care by the CMHT (CMHT group) during the COVID-19 pandemic and two earthquakes. METHOD: This is a cross-sectional survey administered among 90 participants with SMI at two time points: in May/June 2020 (first COVID-19 wave, earthquake) and in December 2020/January 2021 (second COVID-19 wave, earthquake). RESULTS: A significantly larger proportion of participants from the CMHT group visited the general practitioners in both waves of COVID-19 (first wave: CMHT 72.1%, TAU 44.2%, p = .009; second wave: CMHT 91.1%, TAU 64.1%, p = .003), as well as psychiatric services in the second wave (CMHT 95.3%, TAU 79.5%, p = .028). The use of long-acting injectables was also more frequent in the CMHT group (p = .039). Furthermore, analysis of the first wave showed higher perceived support of significant others (p = .004) in the CMHT group. We did not identify any differences in mental health outcomes between groups in either wave. CONCLUSIONS: While mental health outcomes did not differ between TAU and CMHT group, people in CMHT used services and treatments more frequently than those in TAU during the pandemic, which may indicate that CMHT services enable the continuity and accessibility of care for people with SMI under the circumstances where standard care is interruped (for example pandemic, disaster conditions).

Changes in substance use and engagement in gaming/gambling in persons with severe mental illness during the COVID-19 pandemic and earthquakes: a community study in two points.

Introduction: External stressors, such as COVID-19 pandemic and earthquake, can cause an increase in substance use and addictive behavior in persons with severe mental illnesses (SMI). We analyzed the changes and predictors of substance use and addictive behavior in SMI during these double disasters in Croatia. Methods: Questionnaires exploring the presence of substance or behavior addiction disorder, mental ill health [Depression Anxiety Stress Scales-21 (DASS-21), Insomnia Severity Index (ISI), Perceived Stress Scale (PSS), Obsessive-Compulsive Inventory-Revised], coping mechanisms, and perceived social support [Multidimensional Scale of Perceived Social Support (MSPSS)] were administered among 90 participants with SMI included in the RECOVER-E study in May/June 2020 (first COVID-19 wave, Zagreb earthquake) and in December 2020/January 2021 (second COVID-19 wave, Petrinja earthquake). Results: In both time points, a major increase was observed in tobacco smoking (25.0%; 28.6%, respectively) predicted by discontinuation of antidepressants and higher DASS-21 score. Increased sedative use was observed (24.4%; 23.8%, respectively) predicted by higher PSS and ISI scores, lower MSPSS scores, antipsychotic discontinuation and not receiving community mental health team (CMHT) service. Discussion: In persons with SMI during a double disaster special attention needs to be given to reducing mental-ill health and stress, providing social support and continuity of psychiatric care, through medications and CMHTs.

Challenges in Recruiting University Students for Web-Based Indicated Prevention of Depression and Anxiety: Results From a Randomized Controlled Trial (ICare Prevent).

BACKGROUND: Depression and anxiety are common mental health conditions in college and university student populations. Offering transdiagnostic, web-based prevention programs such as ICare Prevent to those with subclinical complaints has the potential to reduce some barriers to receiving help (eg, availability of services, privacy considerations, and students' desire for autonomy). However, uptake of these interventions is often low, and accounts of recruitment challenges are needed to complement available effectiveness research in student populations. OBJECTIVE: The aims of this study were to describe recruitment challenges together with effective recruitment strategies for ICare Prevent and provide basic information on the intervention's effectiveness. METHODS: A 3-arm randomized controlled trial was conducted in a student sample with subclinical symptoms of depression and anxiety on the effectiveness of an individually guided (human support and feedback on exercises provided after each session, tailored to each participant) and automatically guided (computer-generated messages provided after each session, geared toward motivation) version of ICare Prevent, a web-based intervention with transdiagnostic components for the indicated prevention of depression and anxiety. The intervention was compared with care as usual. Descriptive statistics were used to outline recruitment challenges and effective web-based and offline strategies as well as students' use of the intervention. A basic analysis of intervention effects was conducted using a Bayesian linear mixed model, with Bayes factors reported as the effect size. RESULTS: Direct recruitment through students' email addresses via the central student administration was the most effective strategy. Data from 35 participants were analyzed (individually guided: n=14, 40%; automatically guided: n=8, 23%; care as usual: n=13, 37%). Use of the intervention was low, with an average of 3 out of 7 sessions (SD 2.9) completed. The analyses did not suggest any intervention effects other than anecdotal evidence (all Bayes factors10≤2.7). CONCLUSIONS: This report adds to the existing literature on recruitment challenges specific to the student population. Testing the feasibility of recruitment measures and the greater involvement of the target population in their design, as well as shifting from direct to indirect prevention, can potentially help future studies in the field. In addition, this report demonstrates an alternative basic analytical strategy for underpowered randomized controlled trials. TRIAL REGISTRATION: International Clinical Trials Registry Platform NTR6562; https://tinyurl.com/4rbexzrk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-2477-y.

Guided internet-based transdiagnostic individually tailored Cognitive Behavioral Therapy for symptoms of depression and/or anxiety in college students: A randomized controlled trial.

Common mental disorders, such as depression and anxiety, often emerge in college students during the transition into early adulthood. Mental health problems can seriously impact students' functioning, interpersonal relationships, and academic achievement. Actively reaching out to college students with mental health problems and offering them internet-based interventions may be a promising way of providing low-threshold access to evidence-based treatment in colleges. This randomized controlled trial aimed to assess the effectiveness of a guided web-based transdiagnostic individually tailored Cognitive Behavioral Therapy (iCBT) in treating college students with depression and/or anxiety symptoms. Through an online survey that screened college students' mental health, we recruited 100 college students aged ≥18 years who reported mild to moderate depression and/or anxiety symptoms and were attending colleges in the Netherlands. Participants were randomly allocated to guided iCBT (n = 48) or treatment as usual (TAU) control (n = 52). Primary outcomes were symptoms of depression and anxiety measured at post-treatment (7 weeks post-randomization). We also measured all outcomes at 6- and 12-months post-randomization. All analyses were based on the intention-to-treat principle and were repeated using the complete-case sample. We found no evidence of a difference between the effects of guided iCBT and TAU in any of the examined outcomes (i.e., symptoms of depression and anxiety, quality of life, educational achievement, and college dropout) across all time points (p > .05). There was no evidence that effects of iCBT were associated with treatment satisfaction and adherence. More research into transdiagnostic individually tailored iCBT is necessary. Further, future studies should recruit larger samples to investigate possible smaller but clinically relevant effects of internet-based interventions for college students with depression and/or anxiety.

Online therapy: an added value for inpatient routine care? Perspectives from mental health care professionals.

Internet-delivered interventions can be effective in treating mental disorders. However, their rate of use in German psychiatric inpatient routine care is low. The current study aimed to investigate the attitude of mental health care professionals working in inpatient care regarding internet-delivered interventions, including presumed benefits, barriers and facilitators. In total, 176 health professionals from ten inpatient psychiatric hospitals throughout Germany were surveyed on site. The professionals' attitude towards internet-delivered interventions in inpatient care was assessed by an adapted version of the 'Attitude toward Telemedicine in Psychiatry and Psychotherapy' (ATTiP) questionnaire. To identify benefits, barriers and facilitators, we developed open-response questions that were based on the 'Unified Theory of Acceptance and Use of Technology' (UTAUT) and analyzed by a qualitative content analysis. Professionals reported little experience or knowledge about internet-delivered interventions. Their attitude towards internet-delivered interventions in psychiatric inpatient care was rather indifferent. The most frequently mentioned potential benefits were an optimised treatment structure and patient empowerment; the most frequently anticipated barriers were too severe symptoms of patients, the feared neglect of face-to-face contacts and insufficient technical equipment; and the most frequently mentioned facilitators were high usability of the internet-based intervention, a sufficient functional level of the patient and further education of staff. For successful implementation in the inpatient sector, internet-delivered interventions must be adapted to the special needs of severely mentally ill patients and to the hospital management systems and workflow. In addition, technical preconditions (internet access, devices) must be met. Last, further education of mental health care professionals is needed.

E-mental health implementation in inpatient care: Exploring its potential and future challenges.

Background: There is a great evidence base today for the effectiveness of e-mental health, or the use of technology in mental healthcare. However, large-scale implementation in mental healthcare organisations is lacking, especially in inpatient specialized mental healthcare settings. Aim: The current study aimed to gain insights into the factors that promote or hinder the implementation of e-mental health applications on organisational, professional and patient levels in Belgium. Methods: Four Belgian psychiatric hospitals and psychiatric departments of general hospitals invited their professionals and patients to use Moodbuster, which is a modular web-based platform with a connected smartphone application for monitoring. The platform was used in addition to treatment as usual for three to four months. The professionals and patients completed pre- and post-implementation questionnaires on their reasons to participate or to decline participation and experiences with the Moodbuster platform. Results: Main reasons for the organisations to participate in the implementation study were a general interest in e-mental health and seeing it is a helpful add-on to regular treatment. The actual use of Moodbuster by professionals and patients proved to be challenging with only 10 professionals and 24 patients participating. Implementation was hindered by technical difficulties and inpatient care specific factors such as lack of structural facilities to use e-mental health and patient-specific factors. Professionals saw value in using e-mental health applications for bridging the transition from inpatient to outpatient care. Twenty-two professionals and 31 patients completed the questionnaire on reasons not to participate. For the patients, lack of motivation because of too severe depressive symptoms was the most important reason not to participate. For professionals, it was lack of time and high workload. Conclusions: The current implementation study reveals several important barriers to overcome in order to successfully implement e-mental health in inpatient psychiatric care.

Online computer or therapist-guided cognitive behavioral therapy in university students with anxiety and/or depression: study protocol of a randomised controlled trial.

INTRODUCTION: Emerging adulthood is a phase in life that is associated with an increased risk to develop a variety of mental health disorders including anxiety and depression. However, less than 25% of university students receive professional help for their mental health reports. Internet-based cognitive behavioural therapy (iCBT) may entail useful interventions in a format that is attractive for university students. The aim of this study protocol is to test the effectiveness of a therapist-guided versus a computer-guided transdiagnostic iCBT programme with a main focus on anxiety and depression. METHODS AND ANALYSIS: University students with anxiety and/or depressive symptoms will be randomised to a (1) 7-week iCBT programme (excluding booster session) with therapist feedback, (2) the identical iCBT programme with computer feedback only or (3) care as usual. Participants in the care as usual condition are informed and referred to conventional care services and encouraged to seek the help they need. Primary outcome variables are self-reported levels of anxiety as measured with the General Anxiety Disorder-7 and self-reported levels of depression as measured with the Patient Health Questionnaire-9. Secondary outcomes include treatment adherence, client satisfaction, medical service use, substance use, quality of life and academic achievement. Assessments will take place at baseline (t1), midtreatment (t2), post-treatment (t3), at 6 months (t4) and 12 months (t5) postbaseline. Social anxiety and perfectionism are included as potentially important predictors of treatment outcome. Power calculations are based on a 3 (group) × 3 (measurement: pretreatment, midtreatment and post-treatment) interaction, resulting in an aimed sample of 276 participants. Data will be analysed based on intention-to-treat and per protocol samples using mixed linear models. ETHICS AND DISSEMINATION: The current study was approved by the Medical Ethics Review Committee (METC) of the Academic Medical Centre, Amsterdam, The Netherlands (number: NL64929.018.18). Results of this trial will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL7328.

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.

Physiological and self-reported arousal in virtual reality versus face-to-face emotional activation and cognitive restructuring in university students: A crossover experimental study using wearable monitoring.

BACKGROUND: Arousal may be important for learning to restructure ones' negative cognitions, a core technique in depression treatment. In virtual reality (VR), situations may be experienced more vividly than, e.g., in an imaginative approach, potentially aiding the emotional activation of negative cognitions. However, it is unclear whether such activation and subsequent cognitive restructuring in VR elicits more physiological, e.g. changes in skin conductance (SC), heart rate (HR), and self-reported arousal. METHOD: In a cross-over experiment, 41 healthy students experienced two sets, one in VR, one face-to-face (F2F), of three situations aimed at activating negative cognitions. Order of the sets and mode of delivery were randomised. A wristband wearable monitored SC and HR; self-reported arousal was registered verbally. RESULTS: Repeated measures analyses of variance revealed significantly more SC peaks per minute, F (1, 40) = 13.89, p = .001, higher mean SC, F (1,40) = 7.47, p = .001, and higher mean HR, F (1, 40) = 75.84, p < .001 in VR compared to F2F. No differences emerged on the paired-samples t-test for self-reported arousal, t (40) = -1.35, p = .18. DISCUSSION: To the best of our knowledge, this is the first study indicating that emotional activation and subsequent cognitive restructuring in VR can lead to significantly more physiological arousal compared to an imaginative approach. These findings need to be replicated before they can be extended to patient populations.

Mediators in psychological and psychoeducational interventions for the prevention of depression and anxiety. A systematic review.

Although efforts have been undertaken to determine how psychological interventions exert their effects, research on mediators and mechanisms of change remains limited, especially in the field of prevention. We aimed to assess available evidence on mediators of psychological and psychoeducational interventions for the prevention of depression and anxiety in varied populations. A systematic review using PubMed, PsycINFO, Web of Science, Embase, OpenGrey, and the Cochrane Central Register of Controlled Trials was performed. Two independent reviewers assessed the eligibility criteria of all articles, extracted data, determined the risk of bias in randomized controlled trials, and the requirements for mediators. The outcomes were mediators of the incidence of depression or anxiety and/or the reduction of symptoms of depression or anxiety. We identified 28 nested mediator studies within randomized controlled trials involving 7442 participants. Potential cognitive, behavioral, emotional and interpersonal mediators were evaluated in different psychological and psychoeducational interventions to prevent depression and anxiety. The effects were mediated mainly by cognitive variables, which were the most commonly assessed factors. For depression, the mediator with the strongest empirical support was negative thinking in adults. Cognitive change is an important mediator in preventive psychological and psychoeducational interventions for both anxiety and depression. REGISTRATION DETAILS: Registration number (PROSPERO): CRD42018092393.

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.

Examining the effectiveness of a web-based intervention for symptoms of depression and anxiety in college students: study protocol of a randomised controlled trial.

INTRODUCTION: The college years are a peak period for the onset of common mental disorders. Poor mental health is associated with low academic attainment, physical, interpersonal and cognitive impairments. Universities can use online approaches to screen students for mental disorders and treat those in need. The present study aims to assess the effectiveness of a guided web-based transdiagnostic individually tailored intervention to treat students with symptoms of depression and/or anxiety. METHODS: and analysis : The present study is a randomised controlled trial. Participants are Dutch college students (≥18 years) with mild to moderate depression and/or anxiety symptoms. The intervention is a guided web-based transdiagnostic individually tailored intervention that targets symptoms of depression and/or anxiety. The intervention consists of seven online sessions with a duration ranging from 4 to 7 weeks depending on individual progress. A booster session is administered 4 weeks after the completion of the seventh session. Primary outcome measures are the Patient Health Questionnaire for depression and the Generalised Anxiety Disorder 7-item scale for anxiety. These scales are administered at screening, post-treatment and follow-up assessments (6 and 12 months post-randomisation). : E THICS AND DISSEMINATION: The Medical Ethics Committee of the Vrije Universiteit Medical Centre has approved the protocol (registration number 2016.583, A2017.362andA2018.421). Results of the trial will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NTR6797; Pre-results.

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.

Efficacy and cost-effectiveness of guided and unguided internet- and mobile-based indicated transdiagnostic prevention of depression and anxiety (ICare Prevent): A three-armed randomized controlled trial in four European countries.

BACKGROUND: Depression and anxiety are highly prevalent and often co-occur. Several studies indicate the potential of disorder-specific psychological interventions for the prevention of each of these disorders. To treat comorbidity, transdiagnostic treatment concepts seem to be a promising approach, however, evidence for transdiagnostic concepts of prevention remains inconclusive. Internet- and mobile-based interventions (IMIs) may be an effective means to deliver psychological interventions on a large scale for the prevention of common mental disorders (CMDs) such as depression and anxiety. IMIs have been shown to be effective in treating CMDs, e.g. in reducing symptoms of depression and anxiety. However, there is a lack of studies examining the efficacy of interventions reducing the incidence of CMDs. Moreover, the comparative cost-effectiveness of guided versus unguided IMIs for the prevention of depression and anxiety has not been studied yet. Hence, this study aims at investigating the (cost-) effectiveness of guided and unguided internet- and mobile-based transdiagnostic individually tailored indicated prevention of depression and anxiety. METHODS: A multi-country three-armed randomized controlled trial will be conducted to compare a guided and unguided intervention to treatment as usual (TAU). Both active conditions are based on the same intervention, ICare Prevent, and differ only with regard to guidance format. Altogether, 954 individuals with subclinical symptoms of depression (CES-D ≥ 16) and anxiety (GAD-7 ≥ 5) who do not have a full-blown disorder will be recruited in Germany, Switzerland, Spain and the Netherlands, and randomized to one of three conditions (guided intervention, unguided intervention, or TAU). The TAU arm will receive access to the training after a 12-month waiting period. The primary outcome will be time to CMD onset (any depression/anxiety disorder) within a follow-up period of 12 months after baseline. Secondary outcomes will include disorder-specific symptom severity (depression/anxiety) assessed by diagnostic raters blinded to intervention condition at post-intervention, self-reports, acceptability, health related quality of life, and psychosocial variables associated with developing a CMD. Assessments will take place at baseline, mid-intervention (5 weeks into the intervention), post-intervention (8 weeks after randomization) and follow-up (6 and 12 months after randomization). Data will be analyzed on an intention-to-treat basis and per protocol. Cost-effectiveness will be evaluated from a public health and a societal perspective, including both direct and indirect costs. DISCUSSION: The present study will further enhance the evidence-base for transdiagnostic preventive interventions and provide valuable information about optimal trade-off between treatment outcome and costs. TRIAL REGISTRATION: German Clinical Trial Registration (DRKS - http://www.drks.de/drks_web/): DRKS00011099.

Effectiveness of a transdiagnostic individually tailored Internet-based and mobile-supported intervention for the indicated prevention of depression and anxiety (ICare Prevent) in Dutch college students: study protocol for a randomised controlled trial.

BACKGROUND: Depression and anxiety are common and co-morbid disorders that affect a significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their health burden and costs. ICare Prevent is such an innovative strategy and contains a transdiagnostic individually tailored Internet-based and mobile-supported intervention. It addresses common risk factors of depression and anxiety as part of a large EU-funded multi-country project* (ICare). Little is known about the clinical and cost-effectiveness of this type of intervention compared to care as usual (CAU) for college students. We hypothesize that ICare Prevent will be more (cost-)effective than CAU in the reduction of symptoms of depression and anxiety. METHODS: A three-arm, parallel, randomized controlled superiority trial will be conducted comparing a guided and an unguided version of ICare Prevent with a control group receiving CAU. The trial will be open-label but outcome assessors will be blinded. A total of 252 college students (age ≥ 16 years) with subclinical symptoms of depression defined as a score ≥ 16 on the Center for Epidemiological Studies Depression Scale (CES-D), and/or anxiety, defined as a score ≥ 5 on the Generalized Anxiety Disorder scale (GAD-7), will be included. Those meeting diagnostic criteria for a depressive or anxiety disorder will be excluded. The primary outcome is change in disorder specific symptom severity from baseline to post-intervention. Secondary endpoints include self-reported depression and anxiety symptoms as well as time to onset of a mood or anxiety disorder until 12-month follow-up. Societal costs and quality of life will be assessed to estimate the intervention's cost-effectiveness compared to CAU. DISCUSSION: Transdiagnostic individually tailored Internet-based prevention could be a (cost-)effective approach to tackle the disease burden of depression and anxiety among college students. TRIAL REGISTRATION: Dutch trial register, NTR 6562 . Registered on 6 July 2017.