AIMS: This study examines implementation of a Screening, Brief Intervention, and Referral to Treatment (SBIRT) model promoting emotional well-being and access to services.

METHOD: The one-session intervention was implemented in community settings by refugee facilitators during 2017 to 2020. 140 Participants including Afghan (n = 43), Rohingya (n = 41), and Somali (n = 56) refugees were randomized to receive either the intervention at baseline, or to a waitlist control group. At 30 days post-intervention, all participants completed a post-assessment. Additionally, after completing the intervention, participants provided feedback on SBIRT content and process.

RESULTS: Findings indicate the intervention was feasible to implement. Among the full sample, Refugee Health Screening-15 emotional distress scores reduced significantly among participants in the intervention group when compared to those in the waitlist control group. Examining findings by nationality, only Afghan and Rohingya participants in the intervention condition experienced significant reductions in distress scores compared to their counterparts in the control condition. Examining intervention effects on service access outcomes, only Somali participants in the intervention condition experienced significant increases in service access compared to the control condition.

METHODS: This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase.

RESULTS: Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Åsberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]).

CONCLUSIONS: Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in depression appeared to be sustained in patients with TRD.