Collaborative Care for Anxiety and Depression in Epilepsy

Collaborative Care to Improve Quality of Life for Anxiety and Depression in Epilepsy

This is a randomized effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.

Study Overview

• Status: Recruiting
• Conditions: Depression; Epilepsy; Anxiety
• Intervention / Treatment: Behavioral: collaborative care; Behavioral: usual neurology care

Detailed Description

The intervention is a 24-week, evidence-based collaborative care model initiated around the time of a neurology visit. The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi M Munger Clary, MD, MPH; Phone Number: 336-716-7110; Email: hmungerc@wakehealth.edu
• Study Contact Backup: Name: Lauren P Richmond; Phone Number: 336.716.9632; Email: lprichmo@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Lauren P Richmond; Phone Number: 336-716-9632; Email: lprichmo@wakehealth.edu
      • Principal Investigator: Heidi M Munger Clary, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of signed and dated Informed Consent Form
• Stated willingness to comply with all study procedures
• Males and Females; Age >= 18 years
• Diagnosis of epilepsy: Epilepsy diagnosis based on neurology clinician impression or EEG findings
• Anxiety or Depression symptoms
• Receiving clinical neurological care at Atrium Health Wake Forest Baptist

Exclusion Criteria:

• Current participation in another treatment of intervention study
• Cognitive limitations precluding completion of Anxiety and Depression self-report instruments on paper, electronically, or by interview
• Comorbid medical condition with life expectancy less than 6 months
• Not a good candidate for collaborative care due to: Active ongoing treatment by a psychiatrist; Active suicidal ideation; Unstable drug or alcohol abuse; history of past suicide attempt and: currently prescribed 2 or more psychotropic medications for psychiatric indication OR receiving ongoing psychotherapy OR has seen a psychiatrist in the past year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: collaborative care; The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.	Behavioral: collaborative care; a 24-week neurology based collaborative care program consisting of: 1. a series of every 2 weeks care management calls by the care manager to evaluate anxiety, depression, seizures and side effects and deliver brief therapy interventions to the participant, and 2. collaborative care conferences including a psychiatrist to generate expert recommendations for anxiety and depression management and communication of recommendations between the care manger, psychiatrist and neurologist.
Active Comparator: usual neurology care; Ongoing usual neurology care, without the addition of the collaborative care program - current standard care and is thus an ethically appropriate control condition for effectiveness and implementation trials.	Behavioral: usual neurology care; ongoing usual neurology care, without the addition of the collaborative care program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups	adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants adhering to Intervention	adherence of intervention participants to the majority of care management - proportion of intervention group participants meeting minimum adherence metric of 50% call participation at 12 weeks	Week 12
Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care	adults with epilepsy and anxiety or depression symptoms - Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life	Month 6
Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care	adults with epilepsy and anxiety or depression symptoms -- Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms	Month 6
Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups	adults with epilepsy and anxiety or depression symptoms - The score was obtained by computing the sum of the scores obtained by items associated with it, from 0, "not at all", to 3, "nearly every day". The possible total score ranges from 0 to 54, with higher scores indicating worse anxiety symptoms	Month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Generalized Anxiety Disorders- 7(GAD-7) Score between groups	Questionnaire measuring anxiety symptoms-score ranges from 0 to 21, with higher score indicating increased anxiety symptoms - proportion achieving 50% symptom reduction or remission by 6 months	Month 6
Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) between groups	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.	Months 3 and 6
Change in Patient Health Questionnaire-9 (PHQ-9) Score between groups	Score ranges from 0 to 27, with higher score indicating increased depression symptoms - proportion achieving 50% symptom reduction or remission by 6 months	Month 6
Emergency Department (ED)/Hospitalization Visits	Number of hospitalizations or visits to ED.	Month 6
Change in Liverpool Seizure Severity Scale (LSSS) between groups	Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity.	Month 6
Seizure Frequency	Number of seizures experienced by participants - this will be change in seizure frequency and time since last seizure categories from baseline to 6 month follow-up: categorical rating scale developed by Epilepsy Learning Healthcare System & standardized in the American Academy of Neurology (AAN) seizure frequency quality measure	Month 6
Number of Seizure medication adjustments	number of seizure medication adjustments to address side effects or lack of seizure control over 6 months	Month 6
Individual Participant Collaborative Care Call Attendance Percentage	Individual Participant Collaborative Care Call Attendance Percentage	Weeks 12 and 24
change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups	adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state	Month 3
change in brEASI (Brief anxiety in epilepsy survey instrument)	Scores of ≥7 on the Brief anxiety in epilepsy survey instrument (brEASI) indicate probable anxiety disorder. Scores range from 0 to 24, with higher scores indicting increased anxiety symptoms.	Months 3 and 6
Beck Depression Inventory (BDI) change	proportion achieving 50% symptom reduction or remission by 6 months	Month 6
anxiety in epilepsy survey instrument (EASI) change	proportion achieving 50% symptom reduction or remission by 6 months	Month 6
Feasibility of Intervention Measure (FIM) Subject Perspective	Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater feasibility	Baseline and Month 15
Feasibility of Intervention Measure (FIM) Neurologist Perspective	Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater feasibility	Baseline and Month 15
Acceptability of Intervention Measure (AIM) Subject Perspective	Questionnaire to help determine feasibility of Collaborative Care from Participants' perspectives - score ranges from 5-20, with higher score indication greater acceptability	Baseline and Month 15
Acceptability of Intervention Measure (AIM) Neurologist Perspective	Questionnaire to help determine feasibility of Collaborative Care from Neurologists' perspectives - score ranges from 5-20, with higher score indication greater acceptability	Baseline and Month 15
Intervention Appropriateness Measure (IAM) Subject Perspective	Questionnaire to help determine appropriateness of Collaborative Care from participants' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness	Baseline and Month 15
Intervention Appropriateness Measure (IAM) Neurologist Perspective	Questionnaire to help determine appropriateness of Collaborative Care from Neurologists' perspectives. Score ranges form 5-20 with higher score indication greater appropriateness	Baseline and Month 15

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Heidi M Munger Clary, MPH, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Collaborative care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Epilepsy; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: IRB00088764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study is completed and results published by primary study team, de-identified, archived data will be stored for potential use if requested by other qualified researchers including those outside of the study.
• IPD Sharing Time Frame: after results published by primary study team
• IPD Sharing Access Criteria: Access to study data may be provided by the PI if requested by qualified investigators for individual participant data meta-analyses or potentially for other methodologically sound proposals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No