Epilepsy, Post-TraumaticNCT05353452
Collaborative Care in Posttraumatic Epilepsy
A study testing Neurology Based Collaborative Care and SOC Neurological care in people with Epilepsy, Post-Traumatic, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Post-Traumatic
- What is being tested?
- Neurology Based Collaborative Care and SOC Neurological care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2023to 19 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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
- Being tested
- Neurology Based Collaborative Care, SOC Neurological care
- Keywords
- epilepsy, neurological care, collaborative care, anxiety, depression
- Medical subject headings
- Epilepsy, Post-Traumatic, Epilepsy, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurology Based Collaborative CareBehavioural
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.
SOC Neurological careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care | Experimental | Participants in this arm will receive 24 weeks of neurology based collaborative care. Receives: Behavioral: Neurology Based Collaborative Care |
| Standard of Care (SOC) | Active comparator | Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals. Receives: Behavioral: SOC Neurological care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)
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
Measured: Baseline through Month 6
Secondary outcomes (4)
Subject Adherence to Intervention
Proportion of intervention arm participants who attend 50% or more of the care management calls in the first 12 weeks of the intervention.
Measured: Week 12
Change in Epilepsy specific QOLIE-31 score
Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life.
Measured: Baseline through Month 6
Change in Beck Depression Inventory-II (BDI-II) score
Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.
Measured: From baseline through Month 6
Change in Beck Anxiety Index (BAI) score
Anxiety symptom questionnaire-score ranges from 0-61, with higher score indicating more severe anxiety symptoms.
Measured: From baseline through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start30 Apr 2023
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi M. Munger Clary, MD, MPH, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353452
- Sponsor's protocol ID
- IRB00084191
- Other IDs
- 40010222, CDMRP-EP210036
- Status last verified
- Jan 2026
- First submitted
- 25 Apr 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39535875
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy
- ClinicalTrials.gov ID
- NCT05353452
- Acronym / sponsor ID
- IRB00084191
- Conditions
- Epilepsy, Post-Traumatic
- Keywords
- epilepsy, neurological care, collaborative care, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care | Experimental | Behavioral: Neurology Based Collaborative CareParticipants in this arm will receive 24 weeks of neurology based collaborative care. |
| Standard of Care (SOC) | Active comparator | Behavioral: SOC Neurological careParticipants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurology Based Collaborative CareTwenty-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. | Behavioural | Collaborative Care |
| SOC Neurological careUsual 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. | Behavioural | Standard of Care (SOC) |
Primary outcome
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
4 secondary outcomes
Subject Adherence to Intervention
Time frame: Week 12
Change in Epilepsy specific QOLIE-31 score
Time frame: Baseline through Month 6
Change in Beck Depression Inventory-II (BDI-II) score
Time frame: From baseline through Month 6
Change in Beck Anxiety Index (BAI) score
Time frame: From baseline through Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 39535875Munger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi M. Munger Clary, MD, MPH principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurology Based Collaborative Care and SOC Neurological care in people with Epilepsy, Post-Traumatic, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31) (time frame: Baseline through Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.