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Completed

NCT Number: NCT05353452

Collaborative Care 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.

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Key information

Conditions

Epilepsy, Post-Traumatic Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Depression Epilepsy Mental Disorders Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. Individual Participant Collaborative Care Call Attendance Percentage

    Time frame: Week 12 and Week 24

  9. Seizure Frequency

    Time frame: Baseline, Month 3, and Month 6

    Number of seizures experienced by participants

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Prescription Adherence

    Time frame: Month 6

    Collected via review of pharmacy refills--number expected divided by number taken.

  19. 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.

  20. 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.

  21. 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.

  22. Emergency Department (ED)/Hospitalization Visits

    Time frame: From baseline through Month 6

    Number of hospitalizations or visits to ED.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2022
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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