Collaborative Care in Posttraumatic Epilepsy

Wake Forest University (WFU)

Status: Enrolling

Conditions: Epilepsy, Post-Traumatic

Treatments: Behavioral: Neurology Based Collaborative Care; Behavioral: SOC Neurological care

Study type: Interventional

Funder types: Other

Identifiers

NCT05353452

IRB00084191

CDMRP-EP210036 (Other Identifier)

40010222 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Collaborative Care

Experimental group

Description:

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

Treatment:

Behavioral: Neurology Based Collaborative Care

Standard of Care (SOC)

Active Comparator group

Description:

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

Treatment:

Behavioral: SOC Neurological care