{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T22:17:08Z","timestamp":1790633828211,"version":"4.1.0"},"reference-count":141,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"\n Background<\/jats:title>\n Negative symptoms of schizophrenia, such as lack of motivation, pleasure, social interest, and expression, are key contributors to functional impairments in people with schizophrenia. While psychosocial interventions have demonstrated efficacy, no Food and Drug Administration\u2013approved pharmacotherapies exist specifically to target these symptoms. Evidence-based digital therapeutics (DTx) may offer novel, scalable treatment options to augment existing treatments.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This article describes the study design and methods of a phase 3, multicenter, double-blind, randomized controlled study (CONVOKE). It aims to evaluate the effectiveness and safety of CT-155\/BI 3972080 (CT-155), a smartphone-based DTx, as an adjunct to standard-of-care antipsychotic medication in adults with experiential negative symptoms of schizophrenia.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Eligible participants were 18 years or older with a primary diagnosis of schizophrenia receiving stable antipsychotic medication for \u226512 weeks, scored \u22652 on average in at least 2 Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure subscale (CAINS-MAP) domains, and were smartphone owners. Participants were randomized 1:1 to CT-155 (intervention arm) or a digital control app (control arm). CT-155 integrates aspects of multiple evidence-based psychosocial therapeutic techniques, incorporating principles of in-person psychotherapy aimed at targeting negative symptoms. Development of CT-155 was informed by patients during early clinical learning studies using earlier versions of the app. The digital control included elements of the disease educational components of CT-155 and daily digital check-ins. Participants were blinded to their assigned intervention. A blind-to-hypothesis was used so participants appropriately engaged with both apps. Accordingly, participants were informed that they would receive one of 2 interventions under investigation. Investigators, designated site personnel, and central raters were blinded throughout the study. The study comprised a 2-week screening period, 16-week active period, and a 4-week follow-up period. Change in experiential negative symptoms from baseline to Week 16 (primary end point) was assessed using CAINS-MAP (centrally rated). Other study end points included Clinical Assessment Interview for Negative Symptoms Expressivity, Positive and Negative Syndrome Scale, Personal and Social Performance Scale, Dysfunctional Attitudes Scale, Clinical Global Impressions-Severity, and Patient Global Impression of Improvement Scale. Frequency and severity of adverse events were also assessed, as well as engagement and adherence to either app.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Study enrollment began in March 2023 and was completed in January 2025. Overall, 457 participants were enrolled across 66 clinical study sites in the United States.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n We summarize an innovative trial design for CONVOKE, a phase 3 randomized controlled study aimed at assessing the effectiveness, engagement, and safety of CT-155 as an adjunct to standard-of-care for people with negative symptoms of schizophrenia. CONVOKE is the largest-to-date and most robust clinical trial evaluating the effectiveness and safety of a DTx in schizophrenia. The study protocol included a centrally rated primary end point (CAINS-MAP), blind-to-hypothesis, with an appropriately designed digital control.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n ClinicalTrials.gov NCT05838625; https:\/\/www.clinicaltrials.gov\/study\/NCT05838625<\/jats:p>\n <\/jats:sec>\n \n International Registered Report Identifier (IRRID)<\/jats:title>\n DERR1-10.2196\/81293<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/81293","type":"journal-article","created":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T22:00:08Z","timestamp":1759874408000},"page":"e81293","source":"Crossref","is-referenced-by-count":6,"title":["Effectiveness, Engagement, and Safety of a Digital Therapeutic (CT-155\/BI 3972080) for Treating Negative Symptoms in People With Schizophrenia: Protocol for the Phase 3 CONVOKE Randomized Controlled Trial"],"prefix":"10.2196","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2994-3630","authenticated-orcid":false,"given":"Shaheen E","family":"Lakhan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-7375-4724","authenticated-orcid":false,"given":"Cornelia","family":"Dorner-Ciossek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-3429-3740","authenticated-orcid":false,"given":"Olya","family":"Besedina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3800-2864","authenticated-orcid":false,"given":"Faith","family":"Dickerson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5748-5163","authenticated-orcid":false,"given":"Claudia","family":"Hastedt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0036-6419","authenticated-orcid":false,"given":"Ridwana","family":"Isla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5909-8004","authenticated-orcid":false,"given":"Ren\u00e9 S","family":"Kahn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9358-8242","authenticated-orcid":false,"given":"Jean-Pierre","family":"Lindenmayer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-0897-8345","authenticated-orcid":false,"given":"Ruchi","family":"Mehta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-8953-999X","authenticated-orcid":false,"given":"Cassandra","family":"Snipes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4260-7172","authenticated-orcid":false,"given":"Austin","family":"Speier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-4291-8812","authenticated-orcid":false,"given":"Wenbo","family":"Tang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7167-9554","authenticated-orcid":false,"given":"Bailey","family":"Willis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-3034-5242","authenticated-orcid":false,"given":"Jamie Winderbaum","family":"Fernandez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-2950-214X","authenticated-orcid":false,"given":"Christoph","family":"von der Goltz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5289-6932","authenticated-orcid":false,"given":"Abhishek","family":"Pratap","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2025,10,7]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1016\/S2215-0366(21)00395-3"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1038\/s41537-024-00509-6"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1002\/nop2.1205"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1038\/s41380-023-02138-4"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2015.1737"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2024.11.001"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.22m14458"},{"key":"ref8","first-page":"1","year":"2013","journal-title":"Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5)"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2015.67"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S225643"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.162.3.495"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2019.3360"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2014.10.043"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.3390\/jcm11040983"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopsych.2016.11.014"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1093\/schizbullopen\/sgac006"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbaf034"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbac013"},{"key":"ref19","unstructured":"Efficacy, safety, and tolerability of AVP-786 for the treatment of negative symptoms of schizophreniaClinicalTrials.gov2025-09-11https:\/\/www.clinicaltrials.gov\/study\/NCT03896945"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2024.06.017"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2022.05.009"},{"key":"ref22","unstructured":"A trial of the efficacy and the safety of RO6889450 (ralmitaront) vs placebo in patients with an acute exacerbation of schizophrenia or schizoaffective disorderClinicalTrials.gov2025-09-11https:\/\/clinicaltrials.gov\/study\/NCT04512066?tab=results"},{"key":"ref23","unstructured":"A study to assess the effects of RO6889450 (ralmitaront) in participants with schizophrenia or schizoaffective disorder and negative symptomsClinicalTrials.gov2025-09-11https:\/\/clinicaltrials.gov\/study\/NCT03669640"},{"key":"ref24","unstructured":"DailyMed search: 'schizophrenia' and 'negative symptoms' in indications and usageUS National Library of Medicine20252025-07-24https:\/\/dailymed.nlm.nih.gov\/dailymed\/search.cfm?adv=1&labeltype=human&query=34067-9%3A%28negative+symptoms%29+AND+34067-9%3A%28schizophrenia%29+"},{"key":"ref25","unstructured":"DailyMed search: 'schizophrenia' and 'cognitive symptoms' in indications and usageUS National Library of Medicine20252025-07-24https:\/\/dailymed.nlm.nih.gov\/dailymed\/search.cfm?adv=1&labeltype=all&query=34067-9%3A%28scizophrenia%29+AND+34067-9%3A%28cognitive+symptoms%29+"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.1016\/j.cpr.2010.09.002"},{"key":"ref27","unstructured":"Reimagine schizophrenia: transforming how we are treated, function and thriveSchizophrenia & Psychosis Action Alliance2025-07-24https:\/\/sczaction.org\/wp-content\/uploads\/2023\/02\/Scz-PFDD-Report-Slide-Summary-FINAL.pdf"},{"key":"ref28","doi-asserted-by":"publisher","DOI":"10.1016\/s2215-0366(18)30050-6"},{"key":"ref29","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychires.2013.01.015"},{"key":"ref30","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2017.06.001"},{"key":"ref31","unstructured":"FDA patient-focused drug development guidance series for enhancing the incorporation of the patient's voice in medical product development and regulatory decision makingUS Food and Drug Administration2025-09-11https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical"},{"key":"ref32","doi-asserted-by":"publisher","DOI":"10.1176\/appi.focus.18402"},{"key":"ref33","doi-asserted-by":"publisher","DOI":"10.1192\/j.eurpsy.2021.13"},{"key":"ref34","doi-asserted-by":"publisher","DOI":"10.1016\/S2215-0366(25)00031-8"},{"key":"ref35","doi-asserted-by":"publisher","DOI":"10.1186\/s13643-023-02213-5"},{"key":"ref36","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-024-01151-7"},{"key":"ref37","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbu170"},{"key":"ref38","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.2023.21"},{"key":"ref39","doi-asserted-by":"publisher","DOI":"10.1097\/YCO.0000000000000925"},{"key":"ref40","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.116.197103"},{"key":"ref41","doi-asserted-by":"publisher","DOI":"10.1037\/a0037098"},{"key":"ref42","doi-asserted-by":"publisher","DOI":"10.1126\/sciadv.adk3222"},{"key":"ref43","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyg.2016.01759"},{"key":"ref44","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijnsa.2023.100132"},{"key":"ref45","doi-asserted-by":"publisher","DOI":"10.1159\/000496479"},{"key":"ref46","doi-asserted-by":"publisher","DOI":"10.1186\/s12888-015-0610-y"},{"key":"ref47","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbx099"},{"key":"ref48","doi-asserted-by":"publisher","DOI":"10.1037\/0022-006X.76.3.491"},{"key":"ref49","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbn008"},{"key":"ref50","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbab126"},{"key":"ref51","doi-asserted-by":"publisher","DOI":"10.1001\/archgenpsychiatry.2011.1269"},{"key":"ref52","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2024.06.021"},{"key":"ref53","unstructured":"Health workforce projectionsHealth Resources & Services Administration2025-02-27https:\/\/bhw.hrsa.gov\/data-research\/projecting-health-workforce-supply-demand"},{"key":"ref54","doi-asserted-by":"publisher","DOI":"10.1016\/j.amepre.2018.01.004"},{"key":"ref55","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ps.202000649"},{"key":"ref56","doi-asserted-by":"publisher","DOI":"10.1097\/NMD.0b013e31828e0e19"},{"key":"ref57","doi-asserted-by":"publisher","DOI":"10.1007\/s10597-018-00365-6"},{"issue":"5","key":"ref58","first-page":"1","volume":"18","year":"2018","journal-title":"Ont Health Technol Assess Ser"},{"key":"ref59","unstructured":"Psychologists struggle to meet demand amid mental health crisisAmerican Psychological Association2025-02-27https:\/\/www.apa.org\/pubs\/reports\/practitioner\/2022-covid-psychologist-workload"},{"key":"ref60","doi-asserted-by":"publisher","DOI":"10.1007\/s40596-021-01509-9"},{"key":"ref61","doi-asserted-by":"publisher","DOI":"10.1002\/cpp.691"},{"key":"ref62","doi-asserted-by":"publisher","DOI":"10.1016\/j.genhosppsych.2023.05.012"},{"key":"ref63","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopsych.2024.06.026"},{"key":"ref64","doi-asserted-by":"publisher","DOI":"10.2196\/mental.5379"},{"key":"ref65","doi-asserted-by":"publisher","DOI":"10.2196\/11715"},{"key":"ref66","doi-asserted-by":"publisher","DOI":"10.2196\/47094"},{"key":"ref67","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph182312391"},{"key":"ref68","doi-asserted-by":"publisher","DOI":"10.1007\/s41347-021-00222-6"},{"key":"ref69","doi-asserted-by":"publisher","DOI":"10.1177\/1529100614531398"},{"key":"ref70","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2023.00384"},{"issue":"2","key":"ref71","first-page":"5","volume":"72","author":"Fulford, D","year":"2019","journal-title":"J Clin Psychol"},{"key":"ref72","doi-asserted-by":"publisher","DOI":"10.2196\/24406"},{"key":"ref73","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sby078"},{"key":"ref74","author":"Goenjian, H","year":"2025","journal-title":"Feasibility of a Digital Therapeutic for Experiential Negative Symptoms of Schizophrenia: Results from an Exploratory Study"},{"key":"ref75","doi-asserted-by":"publisher","DOI":"10.2196\/29154"},{"key":"ref76","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbu033"},{"key":"ref77","doi-asserted-by":"publisher","DOI":"10.1016\/j.psychres.2024.116025"},{"key":"ref78","doi-asserted-by":"publisher","DOI":"10.3389\/fdgth.2022.823977"},{"key":"ref79","doi-asserted-by":"publisher","DOI":"10.2196\/56960"},{"key":"ref80","unstructured":"Design considerations for pivotal clinical investigations for medical devices, guidance for industry, clinical investigators, institutional review boards and FDA staffUS Food and Drug Administration20132025-09-11https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/design-considerations-pivotal-clinical-investigations-medical-devices"},{"key":"ref81","doi-asserted-by":"publisher","DOI":"10.2196\/64959"},{"key":"ref82","unstructured":"Boehringer Ingelheim and Click Therapeutics receive FDA breakthrough device designation for schizophrenia prescription digital therapeuticBoehringer Ingelheim20252024-07-04https:\/\/www.boehringer-ingelheim.com\/human-health\/mental-disorders\/schizophrenia\/fda-grants-breakthrough-status-schizophrenia-2"},{"key":"ref83","doi-asserted-by":"publisher","DOI":"10.4103\/psychiatry.IndianJPsychiatry_774_19"},{"key":"ref84","doi-asserted-by":"publisher","DOI":"10.1037\/a0028256"},{"issue":"12","key":"ref85","first-page":"32","volume":"6","author":"Morrison, AK","year":"2009","journal-title":"Psychiatry (Edgmont)"},{"key":"ref86","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbp080"},{"key":"ref87","doi-asserted-by":"publisher","DOI":"10.1001\/archgenpsychiatry.2012.652"},{"key":"ref88","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbz141"},{"key":"ref89","doi-asserted-by":"publisher","DOI":"10.1186\/s40359-022-00879-5"},{"key":"ref90","doi-asserted-by":"publisher","DOI":"10.1037\/pst0000170"},{"key":"ref91","doi-asserted-by":"publisher","DOI":"10.1002\/jclp.22944"},{"key":"ref92","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2023.07.010"},{"key":"ref93","doi-asserted-by":"publisher","DOI":"10.1007\/s12264-021-00740-6"},{"key":"ref94","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbt197"},{"key":"ref95","doi-asserted-by":"publisher","DOI":"10.1001\/archgenpsychiatry.2011.129"},{"key":"ref96","doi-asserted-by":"publisher","DOI":"10.1177\/0145445518805682"},{"key":"ref97","unstructured":"Exploratory study of a digital therapeutics in people with schizophreniaClinicalTrials.gov2025-09-11https:\/\/clinicaltrials.gov\/study\/NCT05438160"},{"key":"ref98","unstructured":"CFR - code of federal regulations title 21US Food and Drug Administration20252025-09-11https:\/\/www.ecfr.gov\/current\/title-21"},{"key":"ref99","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2012.12010109"},{"key":"ref100","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2004.09.010"},{"key":"ref101","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbj053"},{"key":"ref102","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2011.06.030"},{"key":"ref103","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/13.2.261"},{"issue":"4","key":"ref104","first-page":"323","volume":"101","author":"Morosini, PL","year":"2000","journal-title":"Acta Psychiatr Scand"},{"key":"ref105","author":"Weissman, AN","year":"1978","journal-title":"Development and Validation of the Dysfunctional Attitude Scale: A Preliminary Investigation"},{"key":"ref106","author":"Weissman, AN","year":"1979","journal-title":"The Dysfunctional Attitude Scale: A Validation Study"},{"key":"ref107","doi-asserted-by":"publisher","DOI":"10.1034\/j.1600-0447.107.s416.5.x"},{"key":"ref108","doi-asserted-by":"publisher","DOI":"10.1080\/09638288.2019.1643416"},{"key":"ref109","doi-asserted-by":"publisher","DOI":"10.3889\/oamjms.2016.015"},{"key":"ref110","unstructured":"EuroQol 5-dimension 5-level scaleEuroQol2025-01-27https:\/\/euroqol.org\/"},{"key":"ref111","doi-asserted-by":"publisher","DOI":"10.1097\/00004850-199606003-00015"},{"key":"ref112","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2011.10111704"},{"key":"ref113","unstructured":"An extension study of a second course of a digital therapeutic for the treatment of experiential negative symptoms of schizophreniaClinicalTrials.gov2025-09-11https:\/\/clinicaltrials.gov\/study\/NCT06067984"},{"key":"ref114","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2015.04.008"},{"key":"ref115","doi-asserted-by":"publisher","DOI":"10.1037\/ccp0000599"},{"key":"ref116","doi-asserted-by":"publisher","DOI":"10.1002\/wps.20941"},{"key":"ref117","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)32802-7"},{"key":"ref118","doi-asserted-by":"publisher","DOI":"10.1177\/009286150804200402"},{"key":"ref119","doi-asserted-by":"publisher","DOI":"10.1080\/10543400903243009"},{"key":"ref120","doi-asserted-by":"publisher","DOI":"10.1111\/j.0065-1591.2000.0ap25.x"},{"key":"ref121","doi-asserted-by":"publisher","DOI":"10.1080\/14737175.2021.1898947"},{"key":"ref122","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2020.09.020"},{"key":"ref123","doi-asserted-by":"publisher","DOI":"10.1017\/S0033291721000246"},{"key":"ref124","author":"Epping, EA","year":"2025","journal-title":"Schizophrenia and Psychotic Spectrum Disorders"},{"key":"ref125","unstructured":"Recommendations for the use of clinical data in premarket notification [510(k)] submissions. Draft guidance for industry and Food and Drug Administration staffUS Food and Drug Administration20232025-09-11https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/recommendations-use-clinical-data-premarket-notification-510k-submissions"},{"key":"ref126","unstructured":"ICH E9 statistical principles for clinical trials - scientific guidelineEuropean Medicines Agency20202025-09-11https:\/\/www.ema.europa.eu\/en\/ich-e9-statistical-principles-clinical-trials-scientific-guideline"},{"key":"ref127","unstructured":"Points to consider on multiplicity issues in clinical trialsEuropean Medicines Agency20222025-09-11https:\/\/www.ema.europa.eu\/en\/multiplicity-issues-clinical-trials-scientific-guideline"},{"key":"ref128","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbq104"},{"key":"ref129","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbj013"},{"key":"ref130","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e3181d20912"},{"key":"ref131","doi-asserted-by":"publisher","DOI":"10.3389\/fdsfr.2022.900946"},{"key":"ref132","unstructured":"Attachment B - clarifying requirements in digital health technologies researchOffice for Human Research Protections (OHRP)20202025-07-01https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/april-7-2020-attachment-b\/index.html"},{"key":"ref133","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sby135"},{"key":"ref134","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2021.0326"},{"key":"ref135","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2019.10.026"},{"key":"ref136","doi-asserted-by":"publisher","DOI":"10.2196\/46179"},{"key":"ref137","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-024-01388-y"},{"key":"ref138","unstructured":"A prospective cohort study to assess clinical effectiveness of an investigational digital therapeutic (CT-155) in patients with experiential negative symptoms of schizophreniaClinicalTrials.gov2025-09-11https:\/\/www.clinicaltrials.gov\/study\/NCT06791122"},{"key":"ref139","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-023-00777-z"},{"key":"ref140","unstructured":"A global clinical research data sharing platformVivli2025-09-22https:\/\/vivli.org\/"},{"key":"ref141","unstructured":"Data and document sharingMyStudyWindow2025-09-22https:\/\/www.mystudywindow.com\/msw\/datasharing"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.researchprotocols.org\/2025\/1\/e81293","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:15:02Z","timestamp":1782843302000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2025\/1\/e81293"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,7]]},"references-count":141,"URL":"https:\/\/doi.org\/10.2196\/81293","relation":{"has-preprint":[{"id-type":"doi","id":"10.2196\/preprints.81293","asserted-by":"object"}]},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,7]]}}}