Abstracts

Rationale: Anxiety and depression in epilepsy are underrecognized and undertreated, with major barriers to care being poor access to mental health specialists. One potential solution is epileptologist-prescribed medication and treatment monitoring for anxiety and depression in epilepsy. Methods: At a tertiary care epilepsy center, we implemented a pragmatic, randomized feasibility pilot trial of epileptologist-prescribed antidepressant and biweekly treatment monitoring, versus real-world psychiatry referral order. Recruitment was conducted via a learning health system screening in which all patients seen for routine care by 3 epileptologists completed tablet-based screening for anxiety and depression on clinic arrival, via the Generalized Anxiety Disorder-7 (GAD-7) and Neurological Disorders Depression Inventory-Epilepsy (NDDI-E). Tablet-based screening consent and further questions were triggered by GAD-7≥10 or NDDI-E>15 for clinical and trial screening purposes, followed if appropriate by brief eligibility interview and consent by study staff. After routine epilepsy care, same-day enrollment and randomization was conducted if consent obtained.Inclusion criteria were: GAD-7≥10 or NDDI-E>15, epilepsy, age≥18, past epilepsy clinic visit, and independent instrument completion observed by study staff. Exclusions were: past suicide attempt, current suicidality, pregnancy or lactation, psychogenic seizures, psychiatric hospitalization, hallucinations, past manic symptoms, current mental health provider, allergy to study medications, and current antidepressant.The intervention was: escitalopram 10mg daily prescribed on enrollment, then biweekly chronic care management for 10 weeks by an epilepsy physician assistant, composed of 4 phone-based visits and one clinic visit at 6 weeks; venlafaxine was prescribed if escitalopram was intolerable. Clinical outcomes were anxiety and depression scores (GAD-7, NDDI-E, Beck Anxiety Index, Beck Depression Inventory) and quality of life measures via blinded telephone interview at 6 and 12 weeks, with adherence and other measures at 12 weeks. The primary outcome was feasibility defined as adherence to intervention, with secondary feasibility outcomes being accrual and retention. Sample size target was 30. Results: During the initial 13 months of enrollment (April 30, 2018 to June 4, 2019), 1588 patient visits were pre-reviewed, 74% (1181) met preliminary chart review eligibility, and 78% of these (921) came to the clinic visit. Study team approached individuals for tablet-based screening 781 times, with 681 screenings (86%) completed and 213 (31% of screens) having positive anxiety and/or depression scores. Only 70% of those with symptoms (N=149) opted-in to research screening, with only 13% (N=19) being fully eligible and 6 enrolling. Major reasons for ineligibility among positive symptom screens were: current antidepressant, current mental health provider, and past psychiatric hospitalization. Common reasons for opting-out of research screening or declining to enroll were preferences for psychiatric treatment method and burden of treatment visits. Multiple adjustments to the screening process were implemented to enhance accrual. Conclusions: Despite >1500 visits examined and 781 attempted in-person eligibility screens in this feasibility pilot, the study design is not feasible due to low accrual. Contributing factors were existing or past psychiatric treatment among those with symptoms and treatment preference among those potentially eligible. In response, study of mental health treatment preferences and history is underway in this population. Funding: NIH: NCATS UL1 TR001420, 5KL2TR001421-04; NINDS U24 NS107197