Presentation (CTI)

OBJECTIVES: To assess the extent to which HRQoL outcomes are reported in clinical trials of MDMA- and psilocybin-assisted therapy for PTSD, and to identify the instruments or measures used.
METHODS: A rapid review (through 2026) was conducted using PubMed to identify clinical trials in adults with PTSD receiving PAT. A broad search strategy using psychedelic-related terms was applied to maximize sensitivity; however, eligibility for synthesis was prespecified and restricted to MDMA- or psilocybin-assisted therapy studies. Data were extracted on study characteristics and reported HRQoL, QoL, functional, and related patient-reported outcomes (PROs).
RESULTS: Ninety-seven articles were identified. Sixteen MDMA-assisted therapy studies (11 unique trials) in PTSD populations met study eligibility criteria; no psilocybin-assisted therapy trials in PTSD populations met eligibility criteria. None reported preference-based or generic HRQoL measures (e.g., EQ-5D, SF-36). Instead, studies reported a range of symptom-based and related outcomes. Symptom severity was most commonly assessed (15 of 16 studies), typically using the Clinician-Administered PTSD Scale (CAPS/CAPS-5), followed by measures of functional impairment (7 studies). Additional PROs included depression, sleep quality, substance use, and related constructs such as self-compassion, alexithymia, and posttraumatic growth.
CONCLUSIONS: Clinical studies of MDMA-assisted therapy for PTSD report a range of symptom-based and related PRO measures but do not include preference-based HRQoL measures, limiting their usefulness for HTA. No eligible psilocybin-assisted therapy trials in PTSD populations were identified, highlighting an evidence gap. Future trials should incorporate standardized HRQoL measures to support comparative and value-based decision-making.