Clinical trial NCT05353452: Collaborative Care in Posttraumatic Epilepsy
Official title: Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy, Post-Traumatic
Keywords: epilepsy
neurological care
collaborative care
anxiety
depression
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)
timeFrame: Baseline through Month 6
Secondary outcomes:
measure: Subject Adherence to Intervention
timeFrame: Week 12
measure: Change in Epilepsy specific QOLIE-31 score
timeFrame: Baseline through Month 6
measure: Change in Beck Depression Inventory-II (BDI-II) score
timeFrame: From baseline through Month 6
measure: Change in Beck Anxiety Index (BAI) score
timeFrame: From baseline through Month 6
Other outcomes:
measure: Feasibility of Intervention Measure (FIM)-Subject Perspective
timeFrame: Baseline and Month 3
measure: FIM-Neurologist Perspective
timeFrame: Baseline and Month 3
measure: Acceptability of Intervention Measure (AIM)-Subject Perspective
timeFrame: Baseline and Month 3
measure: AIM-Neurologist Perspective
timeFrame: Baseline and Month 3
measure: Intervention Appropriateness Measure (IAM)-Subject Perspective
timeFrame: Baseline and Month 3
measure: IAM-Neurologist Perspective
timeFrame: Baseline and Month 3
measure: Proportion of participants who attend at least 50% of Scheduled Calls
timeFrame: Week 12 and Week 24
measure: Individual Participant Collaborative Care Call Attendance Percentage
timeFrame: Week 12 and Week 24
measure: Seizure Frequency
timeFrame: Baseline, Month 3, and Month 6
measure: Change in BDI-II Score
timeFrame: From Baseline through Month 3
measure: Change in BAI Score
timeFrame: From Baseline through Month 3
measure: Change in Epilepsy specific QOLIE-31 Score
timeFrame: From Baseline through Month 3
measure: Emotional Subscale-Change in QOLIE-31 Score
timeFrame: Baseline through Month 3
measure: Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E)
timeFrame: From Baseline through Month 6
measure: Change in Mini International Psychiatric Interview (MINI)
timeFrame: From Baseline through Month 6
measure: Change in Generic Quality of Life-SF-36
timeFrame: From Baseline through Month 6
measure: Change in Liverpool Seizure Severity Scale (LSSS)
timeFrame: From Baseline through Month 6
measure: Prescription Adherence
timeFrame: Month 6
measure: Change in Liverpool Adverse Effect Profile (LAEP)
timeFrame: From Baseline through Month 6
measure: Change in Generalized Anxiety Disorders- 7(GAD-7) Score
timeFrame: From Baseline through month 3, From Baseline through month 6
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: From Baseline through month 3, From Baseline through month 6
measure: Emergency Department (ED)/Hospitalization Visits
timeFrame: From baseline through Month 6
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: Heidi M. Munger Clary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: