Collaborative Care in Posttraumatic Epilepsy

NCT ID: NCT05353452

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2026-07-31

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 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.

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 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.

Conditions

Epilepsy, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Collaborative Care

Participants in this arm will receive 24 weeks of neurology based collaborative care.

Group Type: EXPERIMENTAL

Neurology Based Collaborative Care

Intervention Type: BEHAVIORAL

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.

Standard of Care (SOC)

Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.

Group Type: ACTIVE_COMPARATOR

SOC Neurological care

Intervention Type: BEHAVIORAL

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.

Interventions

SOC Neurological care

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.

Intervention Type: BEHAVIORAL

Neurology Based Collaborative 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi M. Munger Clary, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Locations

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heidi M. Munger Clary, MD, MPH

Role: CONTACT

hmungerc@wakehealth.edu

336-716-7110

Facility Contacts

Heidi M. Munger Clary, MD, MPH

Role: primary

hmungerc@wakehealth.edu

336-716-7110

References

Munger Clary HM, Snively BM, Cagle C, Kennerly R, Kimball JN, Alexander HB, Brenes GA, Moore JB, Hurley RA. Collaborative Care to Improve Quality of Life for Anxiety and Depression in Posttraumatic Epilepsy (CoCarePTE): Protocol for a Randomized Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2024 Nov 13;13:e59329. doi: 10.2196/59329.

Reference Type: DERIVED

PMID: 39535875 (View on PubMed)

Other Identifiers

40010222

Identifier Type: OTHER

Identifier Source: secondary_id

CDMRP-EP210036

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00084191

Identifier Type: -

Identifier Source: org_study_id