An interventional study of Neurology Based Collaborative Care and SOC Neurological care in Epilepsy, Post-Traumatic, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of post-traumatic epilepsy, defined by the following:
Exclusion Criteria:
Participants in this arm will receive 24 weeks of neurology based collaborative care.
Behavioral: Neurology Based Collaborative Care
Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.
Behavioral: SOC Neurological 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.
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.
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
Time frame: Baseline through Month 6
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.
Time frame: Week 12
Change in Epilepsy specific QOLIE-31 score
Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life.
Time frame: 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.
Time frame: 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.
Time frame: From baseline through Month 6
Feasibility of Intervention Measure (FIM)-Subject Perspective
Questionnaire to help determine feasibility of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility.
Time frame: Baseline and Month 3
FIM-Neurologist Perspective
Questionnaire to help determine feasibility of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility.
Time frame: Baseline and Month 3
Acceptability of Intervention Measure (AIM)-Subject Perspective
Questionnaire to help determine acceptability of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability.
Time frame: Baseline and Month 3
AIM-Neurologist Perspective
Questionnaire to help determine acceptability of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability.
Time frame: Baseline and Month 3
Intervention Appropriateness Measure (IAM)-Subject Perspective
Questionnaire to help determine appropriateness of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher s indicating greater appropriateness.
Time frame: Baseline and Month 3
IAM-Neurologist Perspective
Questionnaire to help determine appropriateness of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater appropriateness.
Time frame: Baseline and Month 3
Proportion of participants who attend at least 50% of Scheduled Calls
Pertains only to participants randomized to collaborative care intervention
Time frame: Week 12 and Week 24
Individual Participant Collaborative Care Call Attendance Percentage
Time frame: Week 12 and Week 24
Seizure Frequency
Number of seizures experienced by participants
Time frame: Baseline, Month 3, and Month 6
Change in BDI-II Score
Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.
Time frame: From Baseline through Month 3
Change in BAI Score
Anxiety symptom questionnaire- score ranges from 0-61, with higher score indicating more severe anxiety symptoms.
Time frame: From Baseline through Month 3
Change in Epilepsy specific QOLIE-31 Score
Score ranges from 0-100 with higher scores indicating better epilepsy-specific quality of life.
Time frame: From Baseline through Month 3
Emotional Subscale-Change in QOLIE-31 Score
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.
Time frame: Baseline through Month 3
Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E)
Depression symptom questionnaire specifically for those with epilepsy-score ranges from 6 to 24, with a score \>15 indicating presence of a likely major depressive episode.
Time frame: From Baseline through Month 6
Change in Mini International Psychiatric Interview (MINI)
Validated diagnostic interview for Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) psychiatric diagnoses. The instrument indicates whether a current diagnosis of a DSM-V mood or anxiety disorder is present. This outcome will assess for change in presence of a current anxiety or depressive disorder at 6-months compared to baseline.
Time frame: From Baseline through Month 6
Change in Generic Quality of Life-SF-36
This instrument is composed of 8 subscales, each calculated separately on a scale of 0-100, with higher score indicating better generic health-related quality of life for that subscale. This exploratory outcome pertains to the following subscales: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning.
Time frame: From Baseline through Month 6
Change in Liverpool Seizure Severity Scale (LSSS)
Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity.
Time frame: From Baseline through Month 6
Prescription Adherence
Collected via review of pharmacy refills--number expected divided by number taken.
Time frame: Month 6
Change in Liverpool Adverse Effect Profile (LAEP)
Adverse effect questionnaire-score ranges from 19 to 76, with higher score indicating greater burden of adverse effects.
Time frame: From Baseline through Month 6
Change in Generalized Anxiety Disorders- 7(GAD-7) Score
Questionnaire measuring anxiety symptoms-score ranges from 0 to 21, with higher score indicating increased anxiety symptoms.
Time frame: From Baseline through month 3, From Baseline through month 6
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Score ranges from 0 to 27, with higher score indicating increased depression symptoms.
Time frame: From Baseline through month 3, From Baseline through month 6
Emergency Department (ED)/Hospitalization Visits
Number of hospitalizations or visits to ED.
Time frame: From baseline through Month 6
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Epilepsy, Post-Traumatic
Wake Forest University Health Sciences