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However, there are few evidence-based prevention initiatives designed for students. Repetitive Negative Thought (RNT, e.g. worry, rumination) is elevated in university students and is a well-established vulnerability factor for anxiety and depression. Furthermore, there are now evidence-based cognitive-behavioural interventions to tackle RNT. A mobile self-help cognitive-behavioural app targeting RNT, adapted for students may therefore be an effective, scalable, and acceptable way to improve prevention in students.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>An online single blind, two-arm parallel-group Randomised Controlled Trial (RCT) to examine the incidence of major depression and symptoms of anxiety and depression across 12 months in university students aged over 16 who screen into the study with self-reported high levels of worry and\/or rumination and no current diagnosis of major depression. Eligible participants will be randomised to the active intervention arm (usual practice plus using a self-guided mobile app targeting RNT) or to the control arm (usual practice). In total, 648 participants aged over 16, with no current major depression, bipolar disorder or psychosis will be recruited from UK universities. Assessments will take place at baseline (pre-randomisation), 3 months and 12 months post- randomisation. Primary endpoint and outcome is incidence of major depression as determined by self-reported diagnostic criteria at 12-month follow-up. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and academic outcomes are secondary outcomes. Compliance, adverse events, and potentially mediating variables will be carefully monitored.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The trial aims to provide a better understanding of the causal role of tackling RNT (worry, rumination) using a self-help mobile app with respect to preventing depression in university students. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective mobile-health public health strategies for preventing common mental health problems.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.isrctn.com\/ISRCTN86795807\">https:\/\/www.isrctn.com\/ISRCTN86795807<\/jats:ext-link>\n                      Date of registration: 27 October 2022\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12888-024-06079-2","type":"journal-article","created":{"date-parts":[[2024,10,2]],"date-time":"2024-10-02T06:02:11Z","timestamp":1727848931000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["A randomized controlled trial of a self-guided mobile app targeting repetitive negative thought to prevent depression in university students: study protocol of the Nurture-U Reducing Worry prevention trial"],"prefix":"10.1186","volume":"24","author":[{"given":"E. 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Institutional review board approval has been obtained from the FHLS Psychology Ethics Committee at the University of Exeter on 29 September 2022 (Ref: Ethics Application ID: 523085). All participants will provide electronic informed consent. Data will be collected in a pseudonymised manner and stored securely.The study is currently using trial protocol version 2.0 dated 04 December 2023. The trial sponsor is the University of Exeter, Exeter, UK. Protocol modifications are recorded and communicated to trial partners, sponsor, review boards and Trial Steering Committee (TSC).A Trial Steering Committee (TSC) with independent experts in ethics, psychiatry, statistics and a representative from a patient\u2019s association will provide independent oversight of the trial and expert advice, meeting every 6 months, and ensure that it is being conducted in accordance with the principles of Good Clinical Practice and the relevant regulations. There will also be an independent Data Monitoring Committee (DMC) to review adverse events and monitor data with access to group allocation with respect to recruitment, retention, and safety, and report to the TSC. The DMEC will be responsible for monitoring serious adverse effects, protocol violations and any risks emerging from the trial. It has the capacity to conduct an unblinded analysis if concerned about serious adverse effects. Interim analyses will only be conducted at request of the DMC if there is a concern about harmful effects of intervention; based on these analyses, the DMC will make recommendations to the TSC who will decide if the trial or a particular intervention should be discontinued on the basis of participant well-being and safety.Adverse events and other unintended effects of trial interventions or trial conduct will be self-reported on the EDC through open questions asking about any problems arising from participation, standardized questions about self-harm and symptoms at each follow up, healthcare use (including hospitalisation and emergency care) asked at the 3 and 12 month assessments, plus spontaneously reported feedback from participants. All SAEs recorded in the EDC must be reported to the ExeCTU Trial Manager within 24 working hours\/1 working day of becoming aware of the event. Only serious adverse events (SAE) that are related to the trial and unexpected will be reported to the sponsor who will decide if onward reporting to the research ethics committee is required. All SAEs and Adverse Events (AEs) are collated in a report for each TSC\/ DMC meeting.The trial has a risk and safety protocol, which includes action for ancillary care for participants with mental health disorders, including signposting to help, aiding with onward referrals, and contact with a clinician in the team. The sponsor has trial insurance that has provision for compensation for those who suffer harm from trial participation, in the unlikely event it is required.All participants will provide electronic informed consent prior to baseline assessment. All participants can discontinue allocated interventions at their own choice and request.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Prof Watkins developed the rumination-focused cognitive-behavioural therapy adapted for the digital app intervention and receives royalties from Guilford Press for sales of the associated therapy manual. The other authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"649"}}