Collaborative Care in Posttraumatic Epilepsy

NCT05353452 | Recruiting DMC

• 3 other identifiers: IRB0008419140010222CDMRP-EP210036
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Post-Traumatic

Keywords

epilepsy; neurological care; collaborative care; anxiety; depression

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline through Month 6

Secondary Outcomes (4)

• Subject Adherence to Intervention

  Week 12

• Change in Epilepsy specific QOLIE-31 score

  Baseline through Month 6

• Change in Beck Depression Inventory-II (BDI-II) score

  From baseline through Month 6

• Change in Beck Anxiety Index (BAI) score

  From baseline through Month 6

Other Outcomes (22)

• Feasibility of Intervention Measure (FIM)-Subject Perspective

  Baseline and Month 3

• FIM-Neurologist Perspective

  Baseline and Month 3

• Acceptability of Intervention Measure (AIM)-Subject Perspective

  Baseline and Month 3

Study Arms (2)

Collaborative Care

EXPERIMENTAL

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

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.

Behavioral: SOC Neurological care

Interventions

SOC Neurological care 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.

Standard of Care (SOC)

Neurology Based Collaborative Care 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.

Collaborative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39535875 DERIVED

MeSH Terms

Conditions

Epilepsy, Post-Traumatic; Epilepsy; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Heidi M. Munger Clary, MD, MPH

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi M. Munger Clary, MD, MPH

CONTACT

336-716-7110; hmungerc@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: April 30, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)