{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T00:05:24Z","timestamp":1792368324594,"version":"4.4.0"},"reference-count":28,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2027,4,11]],"date-time":"2027-04-11T00:00:00Z","timestamp":1807401600000},"content-version":"am","delay-in-days":314,"URL":"http:\/\/www.elsevier.com\/open-access\/userlicense\/1.0\/"}],"funder":[{"DOI":"10.13039\/100000005","name":"US Department of Defense","doi-asserted-by":"publisher","award":["HT9425-24-1-1021"],"award-info":[{"award-number":["HT9425-24-1-1021"]}],"id":[{"id":"10.13039\/100000005","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contemporary Clinical Trials"],"published-print":{"date-parts":[[2026,6]]},"DOI":"10.1016\/j.cct.2026.108302","type":"journal-article","created":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T16:36:04Z","timestamp":1775666164000},"page":"108302","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"special_numbering":"C","title":["The STRONG STAR adverse events monitoring program for psychological health clinical trials"],"prefix":"10.1016","volume":"165","author":[{"given":"Alan L.","family":"Peterson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John D.","family":"Roache","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoinette R.","family":"Brundige","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacey","family":"Young-McCaughan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.cct.2026.108302_bb0005","author":"U.S. Department of Health and Human Services, Office for Human Research Protections"},{"key":"10.1016\/j.cct.2026.108302_bb0010","author":"Code of Federal Regulations"},{"key":"10.1016\/j.cct.2026.108302_bb0015","author":"U.S. Department of Health and Human Services"},{"key":"10.1016\/j.cct.2026.108302_bb0020","author":"U.S. Department of Health and Human Services, Office for Human Research Protections"},{"key":"10.1016\/j.cct.2026.108302_bb0025","author":"U.S. Department of Health and Human Services"},{"key":"10.1016\/j.cct.2026.108302_bb0030","author":"U.S. Department of Health and Human Services"},{"key":"10.1016\/j.cct.2026.108302_bb0035","author":"U.S. Department of Veterans Affairs & U.S. Department of Defense"},{"key":"10.1016\/j.cct.2026.108302_bb0040","author":"International Council For Harmonisation"},{"key":"10.1016\/j.cct.2026.108302_bb0045","doi-asserted-by":"crossref","DOI":"10.1136\/bmj-2022-073725","article-title":"CONSORT harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials","volume":"381","author":"Junqueira","year":"2023","journal-title":"BMJ"},{"issue":"Supplement_1","key":"10.1016\/j.cct.2026.108302_bb0050","doi-asserted-by":"crossref","first-page":"S64","DOI":"10.1093\/pm\/pnae081","article-title":"Monitoring and reporting adverse events in pragmatic clinical trials testing nonpharmacological pain management interventions","volume":"25","author":"Burns","year":"2024","journal-title":"Pain Med."},{"key":"10.1016\/j.cct.2026.108302_bb0055","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1016\/j.jclinepi.2017.05.004","article-title":"Series: pragmatic trials and real world evidence: paper 7. Safety, quality and monitoring","volume":"91","author":"Irving","year":"2017","journal-title":"J. Clin. Epidemiol."},{"issue":"1","key":"10.1016\/j.cct.2026.108302_bb0060","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1080\/10503307.2023.2286992","article-title":"Adverse events in psychotherapy randomized controlled trials: a systematic review","volume":"35","author":"Klatte","year":"2025","journal-title":"Psychother. Res."},{"issue":"4","key":"10.1016\/j.cct.2026.108302_bb0065","doi-asserted-by":"crossref","first-page":"849","DOI":"10.1016\/j.comppsych.2014.01.001","article-title":"Frequency of reporting of adverse events in randomized controlled trials of psychotherapy vs. psychopharmacotherapy","volume":"55","author":"Vaughan","year":"2014","journal-title":"Compr. Psychiatry"},{"key":"10.1016\/j.cct.2026.108302_bb0070","doi-asserted-by":"crossref","DOI":"10.1002\/14651858.CD003388.pub3","article-title":"Psychological treatment of post-traumatic stress disorder (PTSD)","volume":"3","author":"Bisson","year":"2007","journal-title":"Cochrane Database Syst. Rev."},{"key":"10.1016\/j.cct.2026.108302_bb0075","series-title":"Prolonged Exposure Therapy for PTSD: Emotional Processing of Traumatic Experiences - Therapist Guide","author":"Foa","year":"2019"},{"key":"10.1016\/j.cct.2026.108302_bb0080","series-title":"Cognitive Processing Therapy for PTSD: A Comprehensive Manual","author":"Resick","year":"2024"},{"issue":"1","key":"10.1016\/j.cct.2026.108302_bb0085","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1037\/a0017299","article-title":"How would we know if psychotherapy were harmful?","volume":"65","author":"Dimidjian","year":"2010","journal-title":"Am. Psychol."},{"key":"10.1016\/j.cct.2026.108302_bb0090","author":"U.S. Department of health and human services"},{"issue":"3","key":"10.1016\/j.cct.2026.108302_bb0095","doi-asserted-by":"crossref","first-page":"394","DOI":"10.1037\/a0031474","article-title":"Meta-analysis of dropout in treatments for posttraumatic stress disorder","volume":"81","author":"Imel","year":"2013","journal-title":"J. Consult. Clin. Psychol."},{"issue":"1","key":"10.1016\/j.cct.2026.108302_bb0100","doi-asserted-by":"crossref","DOI":"10.1080\/20008198.2019.1684226","article-title":"Active duty and ex-serving military personnel with post-traumatic stress disorder treated with psychological therapies: systematic review and meta-analysis","volume":"10","author":"Kitchiner","year":"2019","journal-title":"Eur. J. Psychotraumatol."},{"issue":"1","key":"10.1016\/j.cct.2026.108302_bb0105","doi-asserted-by":"crossref","first-page":"152","DOI":"10.1016\/j.cct.2012.10.009","article-title":"The need for expanded monitoring of adverse events in behavioral health clinical trials","volume":"34","author":"Peterson","year":"2013","journal-title":"Contemp. Clin. Trials"},{"key":"10.1016\/j.cct.2026.108302_bb0110","doi-asserted-by":"crossref","first-page":"106583","DOI":"10.1016\/j.cct.2021.106583","article-title":"for the STRONG STAR Consortium and the Consortium to Alleviate PTSD, STRONG STAR and the Consortium to Alleviate PTSD: shaping the future of combat PTSD and related conditions in military and veteran populations","volume":"110","author":"Peterson","year":"2021","journal-title":"Contemp. Clin. Trials"},{"issue":"8","key":"10.1016\/j.cct.2026.108302_bb0115","doi-asserted-by":"crossref","first-page":"1574","DOI":"10.1038\/s41386-022-01266-9","article-title":"Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial","volume":"47","author":"Abdallah","year":"2022","journal-title":"Neuropsychopharmacology"},{"issue":"2","key":"10.1016\/j.cct.2026.108302_bb0120","doi-asserted-by":"crossref","first-page":"21m14367","DOI":"10.4088\/JCP.21m14367","article-title":"for the Consortium to Alleviate PTSD, A double-blind randomized controlled trial of doxazosin for co-occurring PTSD and alcohol use disorder in veterans","volume":"84","author":"Back","year":"2023","journal-title":"J. Clin. Psychiatry"},{"issue":"1","key":"10.1016\/j.cct.2026.108302_bb0125","article-title":"for the Consortium to Alleviate PTSD, Massed vs intensive outpatient prolonged exposure for combat-related posttraumatic stress disorder: a randomized clinical trial, JAMA Netw","volume":"6","author":"Peterson","year":"2023","journal-title":"Open"},{"key":"10.1016\/j.cct.2026.108302_bb0130","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1016\/j.cct.2018.07.016","article-title":"for the Consortium to Alleviate PTSD. Intensive prolonged exposure therapy for combat-related posttraumatic stress disorder: design and methodology of a randomized clinical trial","volume":"72","author":"Peterson","year":"2018","journal-title":"Contemp. Clin. Trials"},{"issue":"1","key":"10.1016\/j.cct.2026.108302_bb0135","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2021.36921","article-title":"Comparison of prolonged exposure vs cognitive processing therapy for treatment of posttraumatic stress disorder among US veterans: a randomized clinical trial","volume":"5","author":"Schnurr","year":"2022","journal-title":"JAMA Netw. Open"},{"key":"10.1016\/j.cct.2026.108302_bb0140","doi-asserted-by":"crossref","unstructured":"van Minnen A, Harned MS, Zoellner L, Mills K. Examining potential contraindications for prolonged exposure therapy for PTSD. Eur. J. Psychotraumatol. 2012;3:https:\/\/doi.org\/10.3402\/ejpt.v3i0.18805. doi:https:\/\/doi.org\/10.3402\/ejpt.v3i0.18805.","DOI":"10.3402\/ejpt.v3i0.18805"}],"container-title":["Contemporary Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1551714426000881?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1551714426000881?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T04:27:41Z","timestamp":1778819261000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1551714426000881"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6]]},"references-count":28,"alternative-id":["S1551714426000881"],"URL":"https:\/\/doi.org\/10.1016\/j.cct.2026.108302","relation":{},"ISSN":["1551-7144"],"issn-type":[{"value":"1551-7144","type":"print"}],"subject":[],"published":{"date-parts":[[2026,6]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"The STRONG STAR adverse events monitoring program for psychological health clinical trials","name":"articletitle","label":"Article Title"},{"value":"Contemporary Clinical Trials","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cct.2026.108302","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Published by Elsevier Inc.","name":"copyright","label":"Copyright"}],"article-number":"108302"}}