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Collaborative Care for Anxiety and Depression in Epilepsy

N/A
Recruiting
Led By Heidi M Munger Clary, MPH
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3 and 6
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing a 24-week intervention by a neurologist to usual neurology care, to see if it is more effective, among 60 adults with epilepsy.

Who is the study for?
This trial is for adults over 18 with epilepsy who also experience anxiety or depression. They must be getting care at Atrium Health Wake Forest Baptist and willing to follow the study's procedures. People with a life expectancy under 6 months, those in another study, or with cognitive issues that prevent them from reporting their mental health status are excluded.
What is being tested?
The trial compares a collaborative care approach versus usual neurology care for managing anxiety and depression in people with epilepsy. It lasts for 24 weeks and involves randomly placing participants into one of these two groups.
What are the potential side effects?
Since this trial focuses on care approaches rather than medication, side effects may not be as prominent as drug trials. However, changes in mental health management could lead to variations in mood, stress levels, or overall well-being.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 3 and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3 and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care
Anxiety
Mental Depression
+1 more
Other study objectives
Acceptability of Intervention Measure (AIM) Neurologist Perspective
Acceptability of Intervention Measure (AIM) Subject Perspective
Mental Depression
+17 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: collaborative careExperimental Treatment1 Intervention
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 II: usual neurology careActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
collaborative care
2018
N/A
~260

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,395 Previous Clinical Trials
2,460,145 Total Patients Enrolled
9 Trials studying Epilepsy
1,727 Patients Enrolled for Epilepsy
Heidi M Munger Clary, MPHPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Collaborative Care Clinical Trial Eligibility Overview. Trial Name: NCT05559749 — N/A
Epilepsy Research Study Groups: collaborative care, usual neurology care
Epilepsy Clinical Trial 2023: Collaborative Care Highlights & Side Effects. Trial Name: NCT05559749 — N/A
Collaborative Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05559749 — N/A
~9 spots leftby Mar 2025
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