Status:
RECRUITING
Collaborative Care in Posttraumatic Epilepsy
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Epilepsy, Post-Traumatic
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 univers...
Eligibility Criteria
Inclusion
- 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) ≥8 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) \>13
- Receiving clinical neurological care at one of the study sites
Exclusion
- 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.
Key Trial Info
Start Date :
April 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05353452
Start Date
April 30 2023
End Date
July 1 2026
Last Update
October 1 2025
Active Locations (1)
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1
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157