Epilepsy, Post-Traumatic
Conditions
Keywords
epilepsy, neurological care, collaborative care, anxiety, depression
Brief summary
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
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 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.
Interventions
BEHAVIORALNeurology Based Collaborative Care
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.
BEHAVIORALSOC Neurological care
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. 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) 2. 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 3. TBI pre-dated onset of epilepsy (NINDS post-traumatic epilepsy screening form) * Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥8 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) \>13 * Receiving clinical neurological care at one of the study sites
Exclusion criteria
* Active ongoing treatment by a psychiatrist without the potential to benefit from additional collaborative care for anxiety or depression in the judgement of the investigators * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31) | Baseline through Month 6 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Adherence to Intervention | Week 12 | Proportion of intervention arm participants who attend 50% or more of the care management calls in the first 12 weeks of the intervention. |
| Change in Epilepsy specific QOLIE-31 score | Baseline through Month 6 | Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life. |
| Change in Beck Depression Inventory-II (BDI-II) score | From baseline through Month 6 | Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms. |
| Change in Beck Anxiety Index (BAI) score | From baseline through Month 6 | Anxiety symptom questionnaire-score ranges from 0-61, with higher score indicating more severe anxiety symptoms. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeidi M. Munger Clary, MD, MPH
Atrium Health Wake Forest Baptist
Outcome results
None listed