Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
Contact Information
Primary
Heidi M. Munger Clary, MD, MPH
hmungerc@wakehealth.edu
336-716-7110
Time Frame
Start Date: 2023-04-30
Estimated Completion Date: 2026-07
Participants
Target number of participants: 60
Treatments
Experimental: Collaborative Care
Participants in this arm will receive 24 weeks of neurology based collaborative care.
Active_comparator: Standard of Care (SOC)
Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov