JMIR Publications

ABSTRACT

Background:

Anxiety and depression in people with epilepsy are common and associated with poor outcomes, yet often untreated due to poor mental health specialist access. Collaborative care is an integrated care model with strong evidence base in primary care and medical settings, but it has not been evaluated in neurology clinics. Further, it is important to evaluate implementation outcomes when translating evidence-based interventions to new clinical settings, to inform future scaling and incorporation into real-world practice.

Objective:

The Collaborative Care for Post-traumatic Epilepsy (CoCarePTE) study aims to evaluate effectiveness (improvement in emotional quality of life) and implementation of a collaborative care intervention for people with anxiety and/or depression symptoms and post-traumatic epilepsy.

Methods:

The is a 2-site, randomized, single blind, hybrid type 1 effectiveness-implementation trial that will randomize 60 adults to neurology-based collaborative care versus usual care. Adults with anxiety and/or depression symptoms and a history of at least mild traumatic brain injury prior to epilepsy onset will be enrolled. The collaborative care intervention is a 24-week stepped-care model with calls every 2 weeks by a care manager for measurement-based anxiety/depression care, seizure care monitoring, and brief therapy intervention delivery. This is supplemented by psychiatrist recommendations for neurologist antidepressant prescribing via case conferences and care manager-facilitated team communication. In step 2 of the intervention, individuals with < 50% symptom reduction by 10 weeks will receive an added 8-session remote cognitive-behavioral therapy program. The study is powered to detect a moderate improvement in emotional quality of life.

Results:

As a hybrid type 1 trial, effectiveness is the primary focus, with the primary outcome being a change in emotional quality of life at 6 months in the intervention group vs. control. Secondary effectiveness outcomes are 6-month changes in depression, anxiety, and overall quality of life. Implementation outcomes are evaluated pre-implementation and at 3 months, including fidelity, acceptability, feasibility and appropriateness.

Conclusions:

This trial is novel in its use of a hybrid effectiveness-implementation design to evaluate an evidence-based mental health intervention in epilepsy, and by incorporating seizure care into a collaborative care model. Clinical Trial: ClinicalTrials.gov NCT05353452