(1) Background/Objectives: Over one billion individuals globally live with mental health conditions, yet the treatment gap exceeds 75% in low- and middle-income countries. Large language model (LLM)-based conversational agents have emerged as a potentially scalable solution, though the evidence base remains nascent and largely pre-clinical. This review synthesises barriers and facilitators to their implementation in mental healthcare using the Consolidated Framework for Implementation Research (CFIR). (2) Methods: Eight databases were searched from January 2022 to January 2026. Study selection was managed using Covidence. Two reviewers independently screened, extracted, and appraised studies using the Mixed Methods Appraisal Tool. Directed content analysis guided by CFIR was used for synthesis. (3) Results: Twenty-seven studies (three RCTs, nine mixed methods, eight qualitative, four cross-sectional, three observational) comprising >22,000 participants across 12 countries met inclusion criteria. Five barrier domains (27 sub-themes) and four facilitator domains (22 sub-themes) were identified. Inadequate crisis detection (reported in 21/27 studies) and 24/7 availability (reported in 26/27 studies) are the most frequently reported barriers and facilitators, respectively. These figures represent study-level reporting frequencies, not population-level prevalence estimates. CFIR mapping revealed universal coverage for Knowledge and Beliefs (100%) and Patient Needs and Resources (96%) but critical gaps in the Process domain (Evaluating: 7%; Champions: 11%). (4) Conclusions: LLM-based conversational agents demonstrate substantial promise but present critical safety deficiencies. A tiered implementation framework, independent safety certification, and equity-sensitive design are recommended.
Shankar et al. (Thu,) studied this question.