{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T05:46:16Z","timestamp":1791438376634,"version":"4.3.3"},"reference-count":134,"publisher":"S. Karger AG","license":[{"start":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T00:00:00Z","timestamp":1778457600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"},{"start":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T00:00:00Z","timestamp":1778457600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Psychother Psychosom"],"abstract":"<jats:p>Introduction: The effectiveness, scalability, and safety monitoring of commercial direct-to-consumer AI mental health chatbots remain uncertain. Methods: In this systematic review and meta-analysis, eight databases were searched for English peer-reviewed studies (January 1, 2015\u2013December 31, 2025). Randomized controlled trials (RCTs) were meta-analyzed with random-effects models (Hedges\u2019 g). Completion was synthesized with a one-stage binomial-logit generalized linear mixed model; attrition was pooled as the risk ratio. Safety focused on harms reporting interpretability. Results: Fifty-two studies (22 RCTs; N = 110,594) covering 13 commercial chatbots were included. Depression improved versus controls (18 RCTs; N = 3,170): g = \u22120.35 (95% CI: \u22120.56, \u22120.13), about 1.6 PHQ-9 points, below the 5-point minimal clinically important difference; number needed to treat about 6.6. Anxiety effects (15 RCTs; N = 2,936) were uncertain: g = \u22120.37 (95% CI: \u22120.87, 0.12). Loneliness partially reduced (4 RCTs; N = 662): g = \u22120.21 (95% CI: \u22120.39, \u22120.03). Completion pooled at 79.5% (95% CI: 68.0, 87.6%) but showed a scalability gradient. Attrition was similar to controls (RR = 1.01; 95% CI: 0.79, 1.29). Harms reporting was uninterpretable: only 3\/22 RCTs met active-ascertainment criteria. Certainty ranged from low to very low. Conclusion: Commercial AI mental health chatbots may yield modest improvements, most consistently for depression. Loneliness evidence is limited and fragile, while anxiety and affect outcomes remain heterogeneous; for anxiety, net harm cannot be excluded. Completion rates likely overestimate real-world retention, and safety cannot be inferred from \u201cno events\u201d claims in the absence of harms monitoring. These products are best positioned as low-intensity adjuncts requiring safety-by-design baselines.<\/jats:p>","DOI":"10.1159\/000552072","type":"journal-article","created":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T16:01:02Z","timestamp":1778515262000},"page":"1-24","source":"Crossref","is-referenced-by-count":4,"title":["Commercial AI-Based Mental Health Chatbots as Low-Intensity Adjuncts to Psychotherapy: Effectiveness, Adherence, and Safety \u2013 A Systematic Review and Meta-Analysis"],"prefix":"10.1159","author":[{"given":"Hongyi","family":"Yang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangyuan","family":"Chang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumie","family":"Muroi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhao","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weibo","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Cai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2026,5,11]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1038\/s44220-024-00310-5"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1994.03520220035028"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61415-9"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1003955"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)61093-3"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1002\/wps.21069"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)32802-7"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1159\/000365764"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.36676"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1016\/S2215-0366(24)00317-1"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2024.4378"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2021.3539"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-019-0129-6"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1002\/wps.20673"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1002\/wps.21183"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1002\/wps.20883"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-023-00979-5"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1002\/wps.21352"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1093\/jamia\/ocy072"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1109\/JPROC.2012.2225812"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1145\/365153.365168"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.1016\/0004-3702(72)90049-5"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.2196\/mental.7785"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.2196\/12106"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.2196\/26771"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.1016\/S2589-7500(23)00254-6"},{"key":"ref27","doi-asserted-by":"publisher","DOI":"10.1002\/wps.21148"},{"key":"ref28","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-025-01778-w"},{"key":"ref29","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-022-00560-6"},{"key":"ref30","doi-asserted-by":"publisher","DOI":"10.2196\/16021"},{"key":"ref31","doi-asserted-by":"publisher","DOI":"10.1177\/0706743719828977"},{"key":"ref32","doi-asserted-by":"publisher","DOI":"10.2196\/78340"},{"key":"ref33","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2024.04.057"},{"key":"ref34","doi-asserted-by":"publisher","DOI":"10.2196\/48168"},{"key":"ref35","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.13128"},{"key":"ref36","doi-asserted-by":"publisher","DOI":"10.2196\/14567"},{"key":"ref37","doi-asserted-by":"publisher","DOI":"10.1159\/000540212"},{"key":"ref38","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-024-01388-y"},{"key":"ref39","doi-asserted-by":"publisher","DOI":"10.1037\/pst0000246"},{"key":"ref40","doi-asserted-by":"publisher","DOI":"10.1159\/000490574"},{"key":"ref41","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n71"},{"key":"ref42","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4898"},{"key":"ref43","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i4919"},{"key":"ref44","doi-asserted-by":"publisher","DOI":"10.1016\/j.ridd.2018.05.008"},{"key":"ref45","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39489.470347.AD"},{"key":"ref46","doi-asserted-by":"publisher","DOI":"10.1016\/0895-4356(92)90054-Q"},{"key":"ref47","doi-asserted-by":"publisher","DOI":"10.1111\/j.2517-6161.1995.tb02031.x"},{"key":"ref48","doi-asserted-by":"publisher","DOI":"10.2196\/jmir.7.1.e11"},{"key":"ref49","doi-asserted-by":"publisher","DOI":"10.1002\/jrsm.5"},{"key":"ref50","doi-asserted-by":"publisher","DOI":"10.1037\/met0000011"},{"key":"ref51","doi-asserted-by":"publisher","DOI":"10.1037\/met0000405"},{"key":"ref52","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.315.7109.629"},{"key":"ref53","doi-asserted-by":"publisher","DOI":"10.1002\/jrsm.1095"},{"ke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