Quantifying the Relationship Between Clinical Safety and Environmental Impact in Therapeutic LLMs

Large language models are being deployed as mental health support agents at scale, yet only 16% of LLM-based chatbot interventions have undergone rigorous clinical efficacy testing, and simulations reveal psychological deterioration in over one-third of cases. We evaluate four generative models on 250 Prolonged Exposure (PE) therapy scenarios and 146 CBT cognitive restructuring exercises (plus 29 severity-escalated variants), scored by a three-judge LLM panel. All models scored near-perfectly on surface acknowledgment (~0.91-1.00) while therapeutic appropriateness collapsed to 0.22-0.33 at the highest severity for three of four models, with protocol fidelity reaching zero for two. Under CBT severity escalation, one model's task completeness dropped from 92% to 71% while the frontier model's safety-interference score fell from 0.99 to 0.61. We identify a systematic, modality-spanning failure: RLHF safety alignment disrupts the therapeutic mechanism of action by grounding patients during imaginal exposure, offering false reassurance, inserting crisis resources into controlled exercises, and refusing to challenge distorted cognitions mentioning self-harm in PE; and through task abandonment or safety-preamble insertion during CBT cognitive restructuring. These findings motivate a five-axis evaluation framework (protocol fidelity, hallucination risk, behavioral consistency, crisis safety, demographic robustness), mapped onto FDA SaMD and EU AI Act requirements. We argue that no AI mental health system should proceed to deployment without passing multi-axis evaluation across all five dimensions.

Clinical LLMs are often scaled by increasing model size, context length, retrieval complexity, or inference-time compute, with the implicit expectation that higher accuracy implies safer behavior. This assumption is incomplete in medicine, where a few confident, high-risk, or evidence-contradicting errors can matter more than average benchmark performance. We introduce SaFE-Scale, a framework for measuring how clinical LLM safety changes across model scale, evidence quality, retrieval strategy, context exposure, and inference-time compute. To instantiate this framework, we introduce RadSaFE-200, a Radiology Safety-Focused Evaluation benchmark of 200 multiple-choice questions with clinician-defined clean evidence, conflict evidence, and option-level labels for high-risk error, unsafe answer, and evidence contradiction. We evaluated 34 locally deployed LLMs across six deployment conditions: closed-book prompting (zero-shot), clean evidence, conflict evidence, standard RAG, agentic RAG, and max-context prompting. Clean evidence produced the strongest improvement, increasing mean accuracy from 73.5% to 94.1%, while reducing high-risk error from 12.0% to 2.6%, contradiction from 12.7% to 2.3%, and dangerous overconfidence from 8.0% to 1.6%. Standard RAG and agentic RAG did not reproduce this safety profile: agentic RAG improved accuracy over standard RAG and reduced contradiction, but high-risk error and dangerous overconfidence remained elevated. Max-context prompting increased latency without closing the safety gap, and additional inference-time compute produced only limited gains. Worst-case analysis showed that clinically consequential errors concentrated in a small subset of questions. Clinical LLM safety is therefore not a passive consequence of scaling, but a deployment property shaped by evidence quality, retrieval design, context construction, and collective failure behavior.

People increasingly use large language models (LLMs) for mental health support, yet their safety in evolving, high-risk conversations remains poorly characterised. We developed K-Bench, a clinician-calibrated, protected benchmark evaluating 125 model configurations representing 33 base models from 14 providers across a fixed cohort of 200 multi-turn vignettes involving suicide, self-harm, domestic violence, substance misuse, and no-risk presentations. Synthetic patient conversations showed substantial distributional overlap with real human-AI conversations. A frozen GPT-4o judge achieved 94.2% exact agreement with clinician consensus across 6,751 eligible item comparisons from 151 clinician-rated transcripts. Leading models combined strong supportive conversation with combined-risk scores above 95, whereas risk exploration exposed substantial variation among lower-performing configurations. Therapeutic prompting produced configuration-specific gains concentrated among weaker models, while elevated reasoning produced no average improvement. K-Bench combines broader clinical coverage and configuration-scale comparison with a continuously updated public leaderboard whose operational test materials are protected from direct optimisation. The leaderboard is available at www.k-bench.ai.