Collaborative Care for Anxiety and Depression in Epilepsy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epilepsy, Anxiety, Depression

Intervention / Treatment
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* Behavioral: collaborative care
* Behavioral: usual neurology care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, single-blind hybrid effectiveness-implementation study of a neurology clinic-based 24-week collaborative care intervention versus usual neurology care among a total of 60 adults having epilepsy with anxiety and/or depression symptoms, during 6 months follow-up. Participants will be randomized in a 1:1 ratio to collaborative care intervention versus usual neurology care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: collaborative care<br>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<br>* 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.<br>|
| Active Comparator: usual neurology care<br>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<br>* ongoing usual neurology care, without the addition of the collaborative care program<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Collaborative care