Collaborative Care in Posttraumatic Epilepsy

Study Overview
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Brief Summary
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The purpose of this research is to evaluate a 6 month change in quality of life in subjects who receive collaborative care calls compared to those subjects who receive usual neurology care. This is a 2-site trial comparing a 24 week neurology-based collaborative care program to usual neurology care among a total of 60 adults with post-traumatic epilepsy.

Detailed Description
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The study will compare collaborative care versus usual care among N=60 adults with post-traumatic epilepsy and anxiety and/or depression symptoms in Veterans Administration (N=20) and civilian university (N=40) settings at the Salisbury VA and Atrium Health Wake Forest Baptist Health (AHWFB) Neurology. This single-blind study will evaluate effectiveness and implementation of a remotely-delivered, 24-week team-delivered collaborative care intervention, with features adapted from VA Primary Care Mental Health Integration and Whole Health, as well as an existing Family Medicine Collaborative Care Program at AHWFB.

Official Title
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Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy

Conditions
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Epilepsy, Post-Traumatic

Intervention / Treatment
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* Behavioral: Neurology Based Collaborative Care
* Behavioral: SOC Neurological care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures Diagnosis of post-traumatic epilepsy, defined by the following: Epilepsy diagnosis based on neurology clinician impression of diagnosis or electroencephalogram (EEG) findings (EEG findings: presence of interictal epileptiform discharges on EEG or ictal EEG recording of seizure definitively documenting epilepsy diagnosis) History of at least mild traumatic brain injury based on the MIRECC (Mental Illness Research, Education, and Clinical Center) TBI (Traumatic Brain Injury) screening instrument or verified TBI history based on MIRECC research database TBI pre-dated onset of epilepsy (NINDS post-traumatic epilepsy screening form) Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥10 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) >15 Receiving clinical neurological care at one of the study sites Exclusion Criteria: Active ongoing treatment by a psychiatrist Active suicidal ideation History of past suicide attempt Unstable drug or alcohol abuse Unstable or progressive comorbid medical condition Current participation in another treatment or intervention study Cognitive limitations precluding completion of anxiety and depression self-report instruments on paper, electronically, or by interview.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative Care<br>Participants in this arm will receive 24 weeks of neurology based collaborative care. | Behavioral: Neurology Based Collaborative Care<br>* Twenty-four week, evidence-based remote collaborative care model initiated around the time of a neurology visit. The collaborative care team roles include the care manager, psychiatrist, and psychologist/social worker who interact with the patient participant and the patient's neurologist.<br>|
| Active Comparator: Standard of Care (SOC)<br>Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals. | Behavioral: SOC Neurological care<br>* Usual neurology care means ongoing, epilepsy provider-recommended clinic visits, prescriptions, testing and referrals from their epilepsy provider. Mental health referrals or prescribing of antidepressants may potentially occur in this group; these types of interventions will be tracked at outcome assessments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31) | This is a clinically meaningful patient reported outcome measure that was demonstrated to improve in collaborative care efficacy trials in distinct patient groups (including with various different types of medical illness) Score ranges from 0-100 with higher score indicating better quality of life | Baseline through Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Adherence to Intervention | Proportion of intervention arm participants who attend 50% or more of the care management calls in the first 12 weeks of the intervention. | Week 12 | 
| Change in Epilepsy specific QOLIE-31 score | Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life. | Baseline through Month 6 | 
| Change in Beck Depression Inventory-II (BDI-II) score | Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms. | From baseline through Month 6 | 
| Change in Beck Anxiety Index (BAI) score | Anxiety symptom questionnaire-score ranges from 0-61, with higher score indicating more severe anxiety symptoms. | From baseline through Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, neurological care, collaborative care, anxiety, depression