Collaborative Care in Posttraumatic Epilepsy

Epilepsy, Post-Traumatic Clinical Trial

Official title:

Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353452
• Other study ID #: IRB00084191
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Heidi M. Munger Clary, MD, MPH
• Phone: 336-716-7110
• Email: hmungerc[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Wake Forest Baptist Health (AHWFB) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Post-Traumatic

Intervention

Behavioral:
• Neurology Based Collaborative Care
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
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.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of Intervention Measure (FIM)-Subject Perspective	Questionnaire to help determine feasibility of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility.	Baseline and Month 3
Other	FIM-Neurologist Perspective	Questionnaire to help determine feasibility of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility.	Baseline and Month 3
Other	Acceptability of Intervention Measure (AIM)-Subject Perspective	Questionnaire to help determine acceptability of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability.	Baseline and Month 3
Other	AIM-Neurologist Perspective	Questionnaire to help determine acceptability of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability.	Baseline and Month 3
Other	Intervention Appropriateness Measure (IAM)-Subject Perspective	Questionnaire to help determine appropriateness of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher s indicating greater appropriateness.	Baseline and Month 3
Other	IAM-Neurologist Perspective	Questionnaire to help determine appropriateness of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater appropriateness.	Baseline and Month 3
Other	Proportion of participants who attend at least 50% of Scheduled Calls	Pertains only to participants randomized to collaborative care intervention	Week 12 and Week 24
Other	Individual Participant Collaborative Care Call Attendance Percentage		Week 12 and Week 24
Other	Seizure Frequency	Number of seizures experienced by participants	Baseline, Month 3, and Month 6
Other	Change in BDI-II Score	Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.	From Baseline through Month 3
Other	Change in BAI Score	Anxiety symptom questionnaire- score ranges from 0-61, with higher score indicating more severe anxiety symptoms.	From Baseline through Month 3
Other	Change in Epilepsy specific QOLIE-31 Score	Score ranges from 0-100 with higher scores indicating better epilepsy-specific quality of life.	From Baseline through Month 3
Other	Emotional Subscale-Change in QOLIE-31 Score	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 3
Other	Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E)	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.	From Baseline through Month 6
Other	Change in Mini International Psychiatric Interview (MINI)	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.	From Baseline through Month 6
Other	Change in Generic Quality of Life-SF-36	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.	From Baseline through Month 6
Other	Change in Liverpool Seizure Severity Scale (LSSS)	Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity.	From Baseline through Month 6
Other	Prescription Adherence	Collected via review of pharmacy refills--number expected divided by number taken.	Month 6
Other	Change in Liverpool Adverse Effect Profile (LAEP)	Adverse effect questionnaire-score ranges from 19 to 76, with higher score indicating greater burden of adverse effects.	From Baseline through Month 6
Other	Change in Generalized Anxiety Disorders- 7(GAD-7) Score	Questionnaire measuring anxiety symptoms-score ranges from 0 to 21, with higher score indicating increased anxiety symptoms.	From Baseline through month 3, From Baseline through month 6
Other	Change in Patient Health Questionnaire-9 (PHQ-9) Score	Score ranges from 0 to 27, with higher score indicating increased depression symptoms.	From Baseline through month 3, From Baseline through month 6
Other	Emergency Department (ED)/Hospitalization Visits	Number of hospitalizations or visits to ED.	From baseline through Month 6
Primary	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	Subject Adherence to Intervention	Proportion of intervention arm participants who attend 50% or more of the care management calls in the first 12 weeks of the intervention.	Week 12
Secondary	Change in Epilepsy specific QOLIE-31 score	Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life.	Baseline through Month 6
Secondary	Change in Beck Depression Inventory-II (BDI-II) score	Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.	From baseline through Month 6
Secondary	Change in Beck Anxiety Index (BAI) score	Anxiety symptom questionnaire-score ranges from 0-61, with higher score indicating more severe anxiety symptoms.	From baseline through Month 6