Collaborative care for adults with post-traumatic epilepsy
Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy
This study is testing whether a 24-week team-based care program can improve the quality of life for adults with post-traumatic epilepsy, anxiety, and depression compared to regular neurological care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05353452 on ClinicalTrials.gov |
What this trial studies
This research evaluates the impact of a 24-week collaborative care program on the quality of life for adults with post-traumatic epilepsy, anxiety, and/or depression. The study compares outcomes between participants receiving collaborative care calls and those receiving standard neurological care. Conducted at two sites, the Salisbury VA and Atrium Health Neurology, it aims to assess the effectiveness of a remotely-delivered, team-based intervention adapted from existing mental health integration programs. A total of 60 adults will be enrolled to determine the benefits of this collaborative approach.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with post-traumatic epilepsy who also exhibit symptoms of anxiety or depression.
Not a fit: Patients without a diagnosis of post-traumatic epilepsy or those not experiencing anxiety or depression symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with post-traumatic epilepsy and associated mental health symptoms.
How similar studies have performed: Previous studies have shown promise in collaborative care approaches for managing neurological conditions, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Winston-Salem, North Carolina
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Heidi M. Munger Clary, MD, MPH — Atrium Health Wake Forest Baptist
- Study coordinator: Heidi M. Munger Clary, MD, MPH
- Email: hmungerc@wakehealth.edu
- Phone: 336-716-7110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.