Collaborative Care for Anxiety and Depression in Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-04

Study Completion Date

2026-08-31

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.

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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.

Conditions

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Epilepsy Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

The randomization table will be prepared by the study statistician, uploaded by the developer, and concealed from the PI and coordinators in the REDCap data management system until after consent, enrollment and baseline data collection is complete, to minimize bias - once participants are randomized it is just outcome assessor who is truly blinded

Study Groups

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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.

Group Type EXPERIMENTAL

collaborative care

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

usual neurology care

Intervention Type BEHAVIORAL

ongoing usual neurology care, without the addition of the collaborative care program

Interventions

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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.

Intervention Type BEHAVIORAL

usual neurology care

ongoing usual neurology care, without the addition of the collaborative care program

Intervention Type BEHAVIORAL

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

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
* History of past suicide attempt and:
* receiving ongoing psychotherapy OR
* has seen a psychiatrist in the past year
* History of suicide attempt in the past year and:
* currently prescribed 2 or more psychotropic medications for psychiatric indication (not merely as a hypnotic) AND not felt to be a good candidate for collaborative care based on the judgement of the investigators
* Unstable drug or alcohol abuse

For the third Aim (sustainability supplement: intervention only care delivery exploratory study supplement) - the Participants meeting the following criteria may participate

* individuals who meet the above INC-EXC criteria and have completed the Control Arm of a collaborative care research study - NCT05559749 - NCT05353452 or
* individuals who meet the above INC-EXC criteria except rather than having a diagnosis of Epilepsy; they have a diagnosis of functional neurological disorder with seizures

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No