NCT05353452Completed
Collaborative Care in Posttraumatic Epilepsy
Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 25 Apr 2022
- Start date
- 30 Apr 2023
- Primary completion date
- 19 May 2026
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Epilepsy
- NCT number
- NCT05353452
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 30 Apr 2023 to the primary completion date, 19 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unstable drug or alcohol abuse
Other illness
- History of past suicide attempt
- Unstable or progressive comorbid medical condition
Other
- 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
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atrium Health Wake Forest Baptist Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.