Collaborative Care to Improve Quality of Life for Anxiety and Depression in Post-Traumatic Epilepsy

Principal Investigator: MUNGER CLARY, HEIDI M

Proposal Number: EP210036

Award Number: W81XWH-22-1-0630

Period of Performance: 7/15/2022 - 7/14/2025

PUBLIC ABSTRACT

People with epilepsy, and especially post-traumatic epilepsy, commonly experience depression and anxiety, and these symptoms affect their quality of life more than seizures. In addition to being the most significant predictors of poor quality of life in epilepsy, anxiety and depression can lead to other problems including hospitalizations, worsened side effects, worsened memory, and even death from suicide. In spite of this importance, anxiety and depression often go unrecognized and untreated, due in part to shortages of psychiatrists and other behavioral health specialists. Based on our prior research, neurologists are willing to potentially prescribe medications for anxiety and depression, and patients have indicated desire to receive anxiety and depression treatment from neurologists. However, our prior research also shows that usual neurology care does not improve quality of life. Therefore, better treatments are needed that can be started in a neurology clinic and help overcome shortages of behavioral health specialists.

A promising potential solution is collaborative care. This is a team-based treatment similar to treatments already used in Department of Veterans Affairs (VA) primary care settings, other primary care settings, and some specialty clinics that improves anxiety, depression and quality of life. This type of clinic-based collaborative care has not been tested in neurology settings or post-traumatic epilepsy, yet it could be highly effective and has the potential to be used widely in settings that can benefit individuals with post-traumatic epilepsy in Veteran, military, and civilian communities. In this study, we will assess a neurology-oriented collaborative care intervention among 60 adults with post-traumatic epilepsy and anxiety or depression who receive care at a VA or a university specialty clinic. Half of the participants will be randomly assigned to collaborative care, and the other half will be assigned to receive their usual neurology care. We will evaluate three main areas to see how the intervention works. First, we will assess implementation of the collaborative care intervention among the people assigned to it, to see if they are able to participate in the collaborative care calls (fidelity) and to see if they and their neurologists consider the intervention acceptable, feasible, and appealing. Second, and most importantly, we will assess the impact of the 24-week collaborative care intervention on emotional quality of life, epilepsy-related and general quality of life, along with anxiety and depression. We will also explore whether seizure frequency or severity influences quality of life in the intervention, and whether medication side effects or missed medication affects quality of life with the intervention.

This study is new and exciting because the intervention is brand new to neurology clinics, it is delivered without the need for additional in-person visits, and because we are using study methods to examine how the intervention could be introduced in other settings (using implementation science), which increases the chances the intervention can be spread rapidly to other places if it works well. This is important because the intervention improves quality of life in other groups of patients, and is a way that neurologists could help improve the most important drivers of poor quality of life in post-traumatic epilepsy (anxiety and depression), which are often untreated or not treated effectively. This has a high chance to impact Veteran, military, and civilian communities because it directly addresses anxiety and depression, which are so common in post-traumatic epilepsy, and are especially relevant for Veteran and military communities that are particularly vulnerable to both post-traumatic epilepsy and anxiety or depression after traumatic brain injury.

TECHNICAL ABSTRACT

Background: Anxiety and depression in epilepsy are highly prevalent, stronger independent predictors of poor quality of life than seizure frequency, and particularly relevant to military, Veteran, and civilian individuals with post-traumatic epilepsy. Post-traumatic epilepsy is overrepresented as an epilepsy cause in prevalent versus incident epilepsy samples, reflecting greater severity, and it is common, accounting for up to 20% of prevalent epilepsies. Post-traumatic epilepsy is a significant predictor of anxiety and depression after traumatic brain injury, and psychiatric history is a risk factor for developing post-traumatic epilepsy after traumatic brain injury. Despite the impact of anxiety and depression in epilepsy on quality of life and other outcomes including suicide in Veterans and civilians with post-traumatic epilepsy, these comorbidities are under-recognized and undertreated. Neurologists face significant barriers to specialty mental health access for epilepsy patients, yet most are willing to prescribe antidepressants. The study team’s prior work demonstrates usual neurology care for anxiety and depression in epilepsy does not improve quality of life, often despite a prescribed antidepressant. However, epilepsy patients desire treatment for anxiety and depression in the neurology setting and are willing to participate in research. Thus, to improve quality of life in post-traumatic epilepsy with anxiety or depression, enhanced care interventions should be studied in the neurology setting. Collaborative care models for managing anxiety and depression are highly effective in non-psychiatry settings and improve quality of life. These models were successfully implemented in Department of Veterans Affairs (VA) primary care settings and various subspecialty settings, yet they have not been investigated in neurology clinics. Considering the relevance of post-traumatic epilepsy to military, Veteran and civilian populations and particular risk for anxiety and depression in post-traumatic epilepsy, it is important to study neurology collaborative care implementation to improve quality of life, anxiety, and depression in post-traumatic epilepsy.

Specific Aims and Hypotheses:

Aim 1: To assess implementation of neurology collaborative care to manage anxiety and/or depression among adults with post-traumatic epilepsy in a two-site randomized trial, with primary implementation outcome being fidelity (patient adherence to the intervention N=30), and secondary outcomes including patient and neurology clinician-level validated measures of acceptability, appropriateness, and feasibility.

Hypothesis 1: Fidelity of the intervention (primary implementation outcome), defined as the proportion of intervention participants (N=30) who attend the majority of care management calls by 12 weeks, is >60%.

Aim 2: To evaluate effectiveness of collaborative care versus usual care on 6-month change in emotional quality of life (primary outcome: emotional well-being subscale of QOLIE-31/SF-36), along with secondary outcomes: epilepsy-specific quality of life, generic quality of life, depression and anxiety.

Hypothesis 2: A moderate clinically significant change in emotional quality of life at 6 months will be observed in the intervention group, compared to the control usual neurology care group.

Exploratory Aim 3: To explore potential mediators of the effect of collaborative care, including seizure factors (seizure frequency, seizure severity) and treatment factors (adverse effects, prescription adherence).

Research Strategy: This is a randomized single-blind effectiveness-implementation study of a 24-week neurology clinic-based collaborative care intervention versus usual neurology care among 60 adults with post-traumatic epilepsy and anxiety and/or depression symptoms in two neurology clinic settings (VA and civilian university epilepsy clinic). The intervention is a remote collaborative care team delivery model initiated around the time of a neurology visit. The team is composed of a care management coach who monitors patient symptoms and provides brief education, care management and problem-based therapy via telephone twice a month, a psychiatrist who provides virtual input at team meetings for delivery of ongoing measurement-based care, and a psychologist/social worker who provides a brief cognitive behavioral therapy series in step 2 of the intervention, if symptoms persist. This team communicates with the neurologist regarding patient seizure status and provides antidepressant prescribing recommendations. Outcome assessment occurs remotely at 3 and 6 months using pragmatic trial methodology developed by the investigators.

Innovation and Impact: This effectiveness-implementation trial of an evidence-based anxiety and depression intervention used widely in primary care, but novel for neurology settings, has the potential to close the anxiety and depression treatment and outcome gap for the high need post-traumatic epilepsy population relevant to military, Veteran, and civilian communities. The novel application of this effective anxiety and depression intervention in this population has high potential for improving quality of life in post-traumatic epilepsy by improving management of anxiety and depression, and is scalable to large health networks such as the VA given the remote delivery method and demonstrated cost-effectiveness.