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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 3 and 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 3 and 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care
Anxiety
Mental Depression
+1 moreOther outcome measures
Acceptability of Intervention Measure (AIM) Neurologist Perspective
Acceptability of Intervention Measure (AIM) Subject Perspective
Mental Depression
+15 moreTrial 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
1,242 Previous Clinical Trials
1,004,207 Total Patients Enrolled
9 Trials studying Epilepsy
1,285 Patients Enrolled for Epilepsy
Heidi M Munger Clary, MPHPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience symptoms of anxiety or depression.I have been diagnosed with epilepsy by a neurologist or through an EEG test.I am 18 years old or older.I have a health condition that may shorten my life to under 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: collaborative care
- Group 2: usual neurology care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an opportunity to participate in this scientific experiment?
"Based on the information available through clinicaltrials.gov, this particular experiment is no longer looking for participants at present time; having been first posted in January 1st 2022 and most recently updated September 26th of same year. However, there are currently 1877 other trials which remain active with recruitment underway."
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