Treatment of post-traumatic stress disorder with medical nitrous oxide combined with exposure to a personal traumatic script: a multicenter randomized controlled trial (POTESTA)

Post-Traumatic Stress Disorder

Changes in symptom severity as assessed by the CAPS-5 at baseline prior to treatment initiation (D0) and at 3 months

PCL-5 score (Posttraumatic Stress Disorder Checklist for DSM-5), measuring the 20 PTSD symptoms according to the DSM-5. At baseline, after the last administration, at 3 months, and at 9 months of follow-up, PHQ-9 score (9-item Patient Health Questionnaire), a self-report measure used to screen for depression and which also provides an indication of symptom severity. At baseline, after the last administration, at 1 month, 3 months, 6 months, and 9 months of follow-up, STAI-State score: assesses the feelings of apprehension, tension, nervousness, and worry that the subject experiences at the time of the consultation. It is an indicator of transient changes in anxiety caused by therapeutic or aversive situations. At baseline, after the last administration, and at 1-month, 3-month, 6-month, and 9-month follow-ups, DES-28 score (Dissociative Experiences Scale – 28 items): a self-report questionnaire used to assess the frequency of various dissociative symptoms in the patient’s daily life. Administered at baseline, after the last treatment session, and at 1-month, 3-month, 6-month, and 9-month follow-ups, FAST: Brief Assessment of Patient Functioning Scale. At baseline, after the last administration, and at 1-month, 3-month, 6-month, and 9-month follow-up, Adverse events will be recorded throughout the study and compared between the two arms

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