Herrero 2019.

Methods	Study design: RCT Study grouping: parallel Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): So far, there are no data about the effect sizes that can be obtained in Internet‐based interventions for the prevention of depression or other common mental health disorders mainly focusing on promoting resilience. However, previous studies on online interventions have shown effect sizes of between 0.36 and 0.50 for the reduction of symptoms of depression and between 0.32 and 0.42 for the reduction of symptoms of anxiety. At least similar effects on improving resilience are expected. Adopting a conservative approach, the sample size is based on the smallest effect size detected in previous studies (Cohen's d = 0.32), a significance level of 0.05, a power of 0.80, and a dropout rate of 30%, on the primary outcome measure (CD‐RISC). The planned sample size of 464 participants is sufficient to detect a small effect size (Cohen's d = 0.32). Covariate adjustment for relevant baseline prognostic factors will further increase the power. To ensure recruitment feasibility, 5 universities (with an estimated number of 170,000 students) will take part in the trial Imputation of missing data: according to study protocol, intention‐to‐treat and per‐protocol analysis; to assess the effect of missing data on the primary analysis the primary outcome will be reanalysed after a multiple imputation strategy (developed within blinded data review) was applied to the data; ITT sample comprises all randomised participants who provided the primary outcome measure within the initially assigned study arm
Participants	Country: Spain, Germany, Switzerland Setting: internet‐based programme Age: not specified in study protocol and conference abstract Sample size (randomised): 464 (planned) Sex: not specified Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: university students with low levels of resilience Inclusion criteria: 1) university students with a score of 1 SD below the mean of the sample on the CD‐ RISC‐25; 2) adequate knowledge to understand and read Spanish or German; 3) access to the internet, and the ability to use a computer Exclusion criteria: 1) university students with a history of a common mental health disorder in the past 12 months; 2) university students who are on a waiting list for psychotherapy or are currently or have been in psychotherapeutic treatment within the past 12 months; 3) individuals with a current psychotic or bipolar disorder or a history of one; 4) individuals at risk for suicide Attrition (withdrawals and exclusions): not specified in study protocol and conference abstract Reasons for missing data: not specified in study protocol and conference abstract
Interventions	Intervention: unguided internet‐based intervention CORE (Cultivating our Resilience; also named as ICare‐R in conference abstract Botella 2016 (n = 232 planned) delivery: internet‐based; CORE runs on Minddistrict platform, a web‐based eHealth platform Minddistrict is the technology partner within the ICare project. The Minddistrict platform allows researchers and therapists to produce intervention content and deliver this content to patients. Among the tools that the platform provides, this trial includes the possibility to record daily data in a mobile application, the use of a logical sequence that allows the therapist to deliver specific content related to the answer given by the patient (conditional content). Moreover, it ensures secure and encrypted communication between patients and therapist includes multimedia elements (videos, audios, vignettes, images); allows user to keep different records through PC and Tablet providers: unguided duration of treatment period and timing: 6 weeks (weekly sessions/modules) description: main objective: to teach skills and strategies to cope with daily life stressors in order to enhance resilience and coping skills, promote self‐empowerment, and increase well‐being 6 interactive modules for weekly sessions: welcome: introduction module to the programme, with an explanation about the tools and how to use CORE psycho‐education; explanation of psychological well‐being and the concept of resilience: a) understand the concept of psychological well‐being, its most important aspects, and their relevance in life; b) understand the concept of resilience and the importance of training and cultivating it autonomy; building my way enhancement of autonomy: a) develop a healthy lifestyle (by pursuing balance in several areas: activity, food, sleep). This lifestyle will allow the person to focus on his/her goals in life; b) increase psychological well‐being by working on the abilities and potentially related to values and goals in life mindfulness and self‐compassion; training in mindfulness, savouring, and an attitude of self‐compassion: a) learn the meaning of “mindfulness”, how to develop this ability, and the benefits that its practice can bring; b) learn to distance ourselves from our thoughts and how to handle them; c) understand the importance of, recognise, capture, and enjoy the good moments; d) develop the skill of kindness and self‐care, i.e. the capacity for self‐compassion overcoming obstacles; development of coping strategies to deal with daily difficulties in life: a) be aware of the importance of facing problems properly; b) learn the problem‐solving technique and how to apply it; c) learn the role of our thoughts in the way we feel and how to be flexible in our way of interpreting situations connecting to others; acknowledge the relevance of relationships and how they can be helpful in the construction of well‐being: a) recognise the importance of our social relations; b) learn to care for and improve our social relations; c) learn to promote quality relationships, which can contribute to maintaining and strengthening resilience purpose in life and personal growth: encourage students to deal with the future with a positive attitude, taking into account what is important for each person and planning the future according to these objectives organised in 6 dimensions: autonomy, self‐acceptance, environmental mastery, purpose in life, positive relations, and personal growth modules also include exercises to practice proposed skills compliance: not specified integrity of delivery: not specified economic information: not specified theoretical basis: therapeutic components are evidence‐based techniques selected following the Riff model of well‐being Control: TAU (n = 232 planned) delivery: not specified providers: not specified in study protocol and conference abstract duration of treatment period and timing: not specified description: usual attention at university; receive access to prevention programme CORE by end of last follow‐up compliance: not specified integrity of delivery:economic information: not specified theoretical basis: not specified
Outcomes	Outcomes collected and reported: Primary outcome: resilience ‐ CD‐RISC Secondary outcomes: well‐being ‐ Ryff Scales of PWB‐29 depression ‐ PHQ positive affect ‐ PANAS negative affect ‐ PANAS anxiety ‐ Generalized Anxiety Disorder Questionnaire perceived stress ‐ PSS‐4 self‐esteem ‐ RSES self‐compassion ‐ SCS ‐ Short Form enjoyment ‐ EOS substance abuse ‐ AUDIT‐Consumption personality ‐ 10‐Item Big Five Inventory economic evaluation ‐ Client Service Receipt Inventory (CSRI) programme evaluation ‐ CEQ; Client Satisfaction Questionnaire working alliance ‐ Working Alliance Inventory for Technology Based Interventions Other measures: sociodemographic data Outcomes reported not specified Time points measured and reported: 1) pre‐intervention; 2) during intervention (4 weeks); 3) post‐intervention (8 weeks); 4) 4‐month follow‐up (at 6 months/24 weeks, i.e. 6 weeks after 8‐week intervention); 5) 10‐month follow‐up (at 12 months/48 weeks, i.e. 40 weeks after 8‐week intervention); resilience at screening, pre‐intervention, post‐intervention and follow‐ups; depression, anxiety, PANAS and perceived stress at all time points but screening; personality and CEQ only at pre‐intervention; self‐esteem, alcohol at pre‐, mid‐, and post‐intervention; well‐being, self‐compassion, CSRI, EOS at pre‐ and post‐intervention and follow‐ups; therapeutic alliance at mid‐ and post‐intervention; treatment satisfaction only at post‐intervention; time points reported not specified Adverse events: not specified
Notes	Contact with authors: We contacted the authors for the study status and received the response that data could not yet be accessed until the recruitment was finished (Herrero 2018 [pers comm]). Study start/end date: see trial registration: September 2015 ‐ July 2019 Funding source: Tfunding from the European Union's Horizon 2020 Research and Innovation Programme under grant agreement No 634757 Declaration of interest: no competing interests declared Ethical approval needed/obtained for study: approved by local ethical commissions in each country Comments by study authors: trial registration number ISRCTN13856522; study is part of the European research project: Integrating Technology into Mental Health Care Delivery in Europe (ICare, No 634757; http://www.icare‐ online.eu) Miscellaneous outcomes by the review authors: see trial registration: recruitment status: no longer recruiting, overall trial status, completed (last update: March 2020); information received from authors: at the end of project, analysis is currently started, first publication expected to be ready by the end of 2019; unclear if final sample included healthcare students Correspondence: Cristina Botella; Universitat Jaume I, Av. Vicent Sos Banyat s/n, Castellón 12071, Spain; botella@uji.es