Consistency of response to rimegepant for the acute treatment of migraine among real-world users - findings from the prospective observational CONFIDENCE study.

Anxiety and mood disorders in youth are prevalent [] and impairing [–], with a high degree of current and lifetime comorbidity, due in part to shared etiologic factors []. Both disorders are markedly undertreated, with only 1 in 5 anxious youth and 2 in 5 depressed youth reporting any lifetime mental health service use, the lowest rates for any youth mental health condition []. Further, there are notable disparities in care. Youth experiencing greater risks associated with social determinants of health (SDOH; e.g., housing insecurity) and youth of color are both at higher risk for disorder [–]. Despite higher risk, these youth are significantly less likely to receive mental health services compared to similarly affected, non-Hispanic white (NHW) youth, and those with greater access to resources [–]. Low-resource families, such as those served by community health centers (CHCs), often experience the burden of multiple intersectional risks and difficulty accessing evidence-based mental health care []. The development of an effective primary-care-based treatment has been proposed as a key tool to (1) broadly increase access to quality care for all youths with anxiety and depression [–] and (2) to reduce disparities in mental health care, helping to improve the public health of the population as a whole [, , ]. In this protocol paper, we describe the rationale, aims, design, and methods of a randomized clinical trial (RCT) to test the clinical effectiveness and probe the implementation readiness of a primary-care-based transdiagnostic intervention for anxiety and depression in underserved lower-income youths. Recent findings support the exploration of transdiagnostic interventions as a promising treatment option for youths with anxiety and depression. These interventions target the underlying mechanisms and symptoms shared across disorders to treat them in a single, streamlined approach [–]. A growing body of evidence from RCTs suggests that transdiagnostic interventions are effective treatments for anxiety and depression in youth, demonstrated by the medium to large effect sizes of these interventions compared to waitlist and active treatment control conditions [–]. A transdiagnostic approach may be particularly well-suited for settings that serve low-resource families, such as CHCs, and be capable of mitigating known challenges in these settings, including high diagnostic comorbidity rates, clinician burden of needing to learn multiple single-disorder treatments, and infrequent therapy visits by families [–]. Reflecting this potential, there is growing interest in testing transdiagnostic models in community settings both nationwide and globally [–]. In a recent investigation, researchers tested the effects of the (UP-A) in community mental health settings []. However, despite showing strong positive effects in previous investigations [, , ], the researchers did not find significant differences between the UP-A and comparison conditions for their primary clinician-rated outcome metric when disseminated into this active practice setting []. The investigators note that these findings may reflect implementation challenges such as high clinician turnover and a potential mismatch between the intervention’s demands and the level of organizational support []. Thus, implementation-focused research is still needed to understand how to best integrate transdiagnostic interventions into real-world clinical contexts.