Anxiety, Depression, Epilepsy
Conditions
Keywords
Quality of Life, Collaborative care
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.
Interventions
BEHAVIORALcollaborative 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.
BEHAVIORALusual neurology care
ongoing usual neurology care, without the addition of the collaborative care program
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * individuals who meet the above INC-EXC criteria and receive clinical neurological care at Atrium Health Wake Forest Baptist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeidi M Munger Clary, MPH
Wake Forest University Health Sciences
Outcome results
None listed