RECRUITING

Collaborative Care in Posttraumatic Epilepsy

Conditions

Epilepsy, Post-Traumatic epilepsy neurological care collaborative care anxiety depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy

Quick Facts

Study Start:2023-04-30

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05353452

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Heidi M. Munger Clary, MD, MPH

CONTACT

336-716-7110

hmungerc@wakehealth.edu

Principal Investigator

Heidi M. Munger Clary, MD, MPH

PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Study Locations (Sites)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Heidi M. Munger Clary, MD, MPH, PRINCIPAL_INVESTIGATOR, Atrium Health Wake Forest Baptist

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 Registration Dates

Study Start Date2023-04-30

Study Completion Date2025-07

Study Record Updates

Study Start Date2023-04-30

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

epilepsy
neurological care
collaborative care
anxiety
depression

Additional Relevant MeSH Terms

Epilepsy, Post-Traumatic