Collaborative Care for Anxiety and Depression in Epilepsy
Purpose
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.
Conditions
- Epilepsy
- Anxiety
- Depression
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention 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.
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
- Masking Description
- 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
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
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.
