OBJECTIVE: This study protocol aims to determine, using a rigorous approach in patients with bipolar disorder (BD) and non-seasonal major depressive episode (MDE), the characteristics of bright light therapy (BLT) administration (duration, escalation, morning and mid-day exposures) depending on the tolerance (hypomanic symptoms). METHODS: Patients with BD I or II and treated by a mood stabilizer are eligible. After 1 week of placebo, patients are randomized between either morning or mid-day exposure for 10 weeks of active BLT with glasses using a dose escalation at 7.5, 10, 15, 30 and 45 minutes/day. A further follow-up visit is planned 6 months after inclusion. Patients will be included by cohorts of 3, with at least 3 days of delay between them, and 1 week between cohorts. If none meet a dose limiting toxicity (DLT; i.e hypomanic symptoms), the initiation dose of the next cohort will be increased. If one patient meet a DLT, an additionnal cohort will start at the same dose. If 2 or 3 patients meet a DLT, from the same cohort or from two cohorts at the same dose initiation, the maximum tolerated dose is defined. This dose escalation will also take into account DLTs observed during the intra-subject escalation on previous cohorts, with a “Target Ceiling Dose” defined if 2 DLTs occured at a dose. DISCUSSION: Using an innovative and more ergonomic device in the form of glasses, this study aims to better codify the use of BLT in BD to ensure a good initiation and tolerance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03396744.
Bipolar Disorder ; Circadian Rhythm ; Cohort Studies ; Eyeglasses ; Follow-Up Studies ; Glass ; Humans ; Maximum Tolerated Dose ; Phototherapy*

Objective: The conduct of a medical interview is a challenging skill, even for the most qualified physicians. Since a training is needed toacquire the necessary skills to conduct an interview with a patient, we compared role-play with standardized patients (SP) training and aconventional lecture for the acquisition of communications skills in undergraduate medical students. Methods: An entire promotion of third year undergraduate medical students, who never received any lessons about communicationsskills, were randomized into 4 arms: 1) SP 2 months before the testing of medical communications skills (SP); 2) conventional lecture 2months before the testing (CL); 3) two control groups (CG) without any intervention, tested either at the beginning of the study or twomonths later. Students were blindly assessed by trained physicians with a modified 17-items Calgary-Cambridge scale. Results: 388 students (98.7%) participated. SP performed better than CL, with significant statistical differences regarding 5 skills: theuse of open and closed questions, encouraging patient responses, inviting the patient to clarify the missing items, encouraging of the patient’semotions, and managing the time and the conduct of the interview. The SP group specifically improved communications skills betweenthe SP training and testing sessions regarding 2 skills: the use of open and closed questions and encouraging patient responses. Noimprovements in communications skills were observed in CG between the two time points, ruling out a possible time effect. Conclusion Role-play with standardized patients appears more efficient than conventional lecture to acquire communication skills inundergraduate medical students. Psychiatry Investig 2020;17(4):299-305