Collaborative Care in Posttraumatic Epilepsy

May 22, 2026 updated by: Wake Forest University Health Sciences

Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist
        • Contact:
        • Principal Investigator:
          • Heidi M. Munger Clary, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Collaborative Care
Participants in this arm will receive 24 weeks of neurology based collaborative care.
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.
Active Comparator: Standard of Care (SOC)
Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)
Time Frame: Baseline through Month 6
This is a clinically meaningful patient reported outcome measure that was demonstrated to improve in collaborative care efficacy trials in distinct patient groups (including with various different types of medical illness) Score ranges from 0-100 with higher score indicating better quality of life
Baseline through Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subject Adherence to Intervention
Time Frame: Week 12
Proportion of intervention arm participants who attend 50% or more of the care management calls in the first 12 weeks of the intervention.
Week 12
Change in Epilepsy specific QOLIE-31 score
Time Frame: Baseline through Month 6
Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life.
Baseline through Month 6
Change in Beck Depression Inventory-II (BDI-II) score
Time Frame: From baseline through Month 6
Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.
From baseline through Month 6
Change in Beck Anxiety Index (BAI) score
Time Frame: From baseline through Month 6
Anxiety symptom questionnaire-score ranges from 0-61, with higher score indicating more severe anxiety symptoms.
From baseline through Month 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention Measure (FIM)-Subject Perspective
Time Frame: Baseline and Month 3
Questionnaire to help determine feasibility of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility.
Baseline and Month 3
FIM-Neurologist Perspective
Time Frame: Baseline and Month 3
Questionnaire to help determine feasibility of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility.
Baseline and Month 3
Acceptability of Intervention Measure (AIM)-Subject Perspective
Time Frame: Baseline and Month 3
Questionnaire to help determine acceptability of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability.
Baseline and Month 3
AIM-Neurologist Perspective
Time Frame: Baseline and Month 3
Questionnaire to help determine acceptability of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability.
Baseline and Month 3
Intervention Appropriateness Measure (IAM)-Subject Perspective
Time Frame: Baseline and Month 3
Questionnaire to help determine appropriateness of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher s indicating greater appropriateness.
Baseline and Month 3
IAM-Neurologist Perspective
Time Frame: Baseline and Month 3
Questionnaire to help determine appropriateness of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater appropriateness.
Baseline and Month 3
Proportion of participants who attend at least 50% of Scheduled Calls
Time Frame: Week 12 and Week 24
Pertains only to participants randomized to collaborative care intervention
Week 12 and Week 24
Individual Participant Collaborative Care Call Attendance Percentage
Time Frame: Week 12 and Week 24
Week 12 and Week 24
Seizure Frequency
Time Frame: Baseline, Month 3, and Month 6
Number of seizures experienced by participants
Baseline, Month 3, and Month 6
Change in BDI-II Score
Time Frame: From Baseline through Month 3
Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.
From Baseline through Month 3
Change in BAI Score
Time Frame: From Baseline through Month 3
Anxiety symptom questionnaire- score ranges from 0-61, with higher score indicating more severe anxiety symptoms.
From Baseline through Month 3
Change in Epilepsy specific QOLIE-31 Score
Time Frame: From Baseline through Month 3
Score ranges from 0-100 with higher scores indicating better epilepsy-specific quality of life.
From Baseline through Month 3
Emotional Subscale-Change in QOLIE-31 Score
Time Frame: Baseline through Month 3
This is a clinically meaningful patient reported outcome measure that was demonstrated to improve in collaborative care efficacy trials in distinct patient groups (including with various different types of medical illness) Score ranges from 0-100 with higher score indicating better quality of life.
Baseline through Month 3
Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E)
Time Frame: From Baseline through Month 6
Depression symptom questionnaire specifically for those with epilepsy-score ranges from 6 to 24, with a score >15 indicating presence of a likely major depressive episode.
From Baseline through Month 6
Change in Mini International Psychiatric Interview (MINI)
Time Frame: From Baseline through Month 6
Validated diagnostic interview for Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) psychiatric diagnoses. The instrument indicates whether a current diagnosis of a DSM-V mood or anxiety disorder is present. This outcome will assess for change in presence of a current anxiety or depressive disorder at 6-months compared to baseline.
From Baseline through Month 6
Change in Generic Quality of Life-SF-36
Time Frame: From Baseline through Month 6
This instrument is composed of 8 subscales, each calculated separately on a scale of 0-100, with higher score indicating better generic health-related quality of life for that subscale. This exploratory outcome pertains to the following subscales: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning.
From Baseline through Month 6
Change in Liverpool Seizure Severity Scale (LSSS)
Time Frame: From Baseline through Month 6
Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity.
From Baseline through Month 6
Prescription Adherence
Time Frame: Month 6
Collected via review of pharmacy refills--number expected divided by number taken.
Month 6
Change in Liverpool Adverse Effect Profile (LAEP)
Time Frame: From Baseline through Month 6
Adverse effect questionnaire-score ranges from 19 to 76, with higher score indicating greater burden of adverse effects.
From Baseline through Month 6
Change in Generalized Anxiety Disorders- 7(GAD-7) Score
Time Frame: From Baseline through month 3, From Baseline through month 6
Questionnaire measuring anxiety symptoms-score ranges from 0 to 21, with higher score indicating increased anxiety symptoms.
From Baseline through month 3, From Baseline through month 6
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time Frame: From Baseline through month 3, From Baseline through month 6
Score ranges from 0 to 27, with higher score indicating increased depression symptoms.
From Baseline through month 3, From Baseline through month 6
Emergency Department (ED)/Hospitalization Visits
Time Frame: From baseline through Month 6
Number of hospitalizations or visits to ED.
From baseline through Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heidi M. Munger Clary, MD, MPH, Atrium Health Wake Forest Baptist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00084191
  • 40010222 (Other Identifier: Department of Defense)
  • CDMRP-EP210036 (Other Identifier: CDMRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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