Collaborative Care for Anxiety and Depression in Epilepsy

Not Applicable

Recruiting

• Conditions: Anxiety; Epilepsy; Depression
• Interventions: Behavioral: collaborative care; Behavioral: usual neurology care

• Registration Number: NCT05559749
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Study Start: 2023-05-04
• Status Verified: 2024-09
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-07
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
collaborative care	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.
usual neurology care	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care	Month 6	adults with epilepsy and anxiety or depression symptoms - Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life
Number of Participants adhering to Intervention	Week 12	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
Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups	Month 6	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
Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care	Month 6	adults with epilepsy and anxiety or depression symptoms -- Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States