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Internet- and mobile-based cognitive behavioural therapy (iCBT) might be one possibility to extend the access to evidence-based treatments. Studies suggest that guided iCBT can reduce anxiety and depression symptoms in AYA. However, little is known about the effectiveness of iCBT for AYA with chronic somatic conditions and comorbid symptoms of anxiety and\/or depression in routine care. Evidence on the (cost-)effectiveness of iCBT is essential for its implementation in health care.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives and methods<\/jats:title><jats:p>This multicentre two-armed randomized controlled trial (RCT) aims to evaluate the (cost-) effectiveness of guided iCBT (youthCOACH<jats:sub>CD<\/jats:sub>) in addition to treatment as usual (TAU) compared to enhanced treatment as usual (TAU+) in AYA aged 12\u201321\u2009years with one of three chronic somatic conditions (type 1 diabetes, cystic fibrosis, or juvenile idiopathic arthritis). AYA with one of the chronic somatic conditions and elevated symptoms of anxiety or depression (Patient Health Questionnaire [PHQ-9] and\/or Generalized Anxiety Disorder [GAD-7]\u00a0Screener score\u2009\u2265\u20097) will be eligible for inclusion. We will recruit 212 patients (2 \u00d7<jats:italic>n<\/jats:italic>\u2009=\u2009106) in routine care through three German patient registries. Assessments will take place at baseline and at 6\u2009weeks, 3 months, 6 months, and 12 months post-randomization. The primary outcome will be combined depression and anxiety symptom severity as measured with the PHQ Anxiety and Depression Scale. Secondary outcomes will include health-related quality of life, coping strategies, self-efficacy, stress-related personal growth, social support, behavioural activation, adjustment and trauma-related symptoms, automatic thoughts, intervention satisfaction, working alliance, and Internet usage. The cost-effectiveness will be determined, and potential moderators and mediators of intervention effects will be explored.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>iCBT might implicate novel ways to increase the access to evidence-based interventions in this specific population. The distinct focus on effectiveness and cost-effectiveness of youthCOACH<jats:sub>CD<\/jats:sub>in patients with chronic somatic conditions, as well as intervention safety, will most likely provide important new insights in the field of paediatric e-mental health. A particular strength of the present study is its implementation directly into routine collaborative health care. As such, this study will provide important insights for health care policy and stakeholders and indicate how iCBT can be integrated into existing health care systems.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>German Clinical Trials Register (DRKS),<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.drks.de\/drks_web\/navigate.do?navigationId=trial.HTML&amp;TRIAL_ID=DRKS00017161\">DRKS00017161<\/jats:ext-link>. Registered on 17 September\u00a02019.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13063-019-4041-9","type":"journal-article","created":{"date-parts":[[2020,3,12]],"date-time":"2020-03-12T13:03:08Z","timestamp":1584018188000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial"],"prefix":"10.1186","volume":"21","author":[{"name":"COACH consortium","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederike","family":"Lunkenheimer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Domhardt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnes","family":"Geirhos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reinhold","family":"Kilian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annabel S.","family":"Mueller-Stierlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reinhard W.","family":"Holl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Meissner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirsten","family":"Minden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morten","family":"Moshagen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramona","family":"Ranz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cedric","family":"Sachser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doris","family":"Staab","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Warschburger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harald","family":"Baumeister","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,3,12]]},"reference":[{"issue":"24","key":"4041_CR1","doi-asserted-by":"publisher","first-page":"2741","DOI":"10.1001\/jama.297.24.2741","volume":"297","author":"J Van Der Lee","year":"2007","unstructured":"Van Der Lee J, Mokkink L, Grootenhuis M, Heymans H, Offringa M. 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Written informed consent is obtained from each participant. Depending on the age of the participant, informed consent from the legal representative or guardian will also be required. The central ethical approval of the Ethics Committee of Ulm University was obtained (request number 292\/18).The COACH consortium will be advised by an external Data and Safety Monitoring Board (DSMB) consisting of three researchers in their areas of expertise: Prof. Dr. Christine Knaevelsrud\u00a0(CS), Free University of Berlin; PD Dr. Levente Kriston\u00a0(LK), University Hospital Hamburg-Eppendorf; Prof. Dr. Claus Peter Schmitt\u00a0(CPS), Heidelberg University Hospital.There are no known risks or side effects of Internet- and mobile-based interventions to reduce depressive symptoms in adults []. However, in case of unexpected (serious) adverse events with inevitable protocol modifications during the conduction of the trial, the necessary changes will be notified to the Ethics Committee of Ulm University and the DSMB.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"HB is a consultant for different insurance companies, health care associations, and psychotherapy chambers and gives talks and workshops and conducts a third party-funded project on iCBT and the dissemination and implementation of iCBT. The remaining authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"253"}}