Screening Tools for Anxiety and Depression in Epilepsy

Overseen By Heidi M. Munger Clary, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1322 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A randomized trial to compare patient-completion success of REDCap and Electronic Health Record (EHR)-based anxiety \& depression instrument delivery methods. Study hypothesis is that the screening completion proportion will vary across the 4 modalities tested.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is it safe to use screening tools for anxiety and depression in people with epilepsy?

Screening tools for anxiety and depression in epilepsy are generally safe, as they are non-invasive questionnaires used to identify symptoms. However, the studies focus more on the effects of anxiety and depression on epilepsy treatment rather than the safety of the screening tools themselves. ^{1 2 3 4 5}

How does this treatment for anxiety and depression in epilepsy differ from other treatments?

This treatment is unique because it involves a screening tool specifically designed to identify anxiety and depression in people with epilepsy, particularly in low-resource settings. Unlike standard treatments that may focus on medication or therapy, this tool aims to improve detection rates of these conditions, which are often underrecognized in epilepsy patients. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Screening Questionnaires for anxiety and depression in epilepsy?

Research shows that using screening questionnaires can help detect and treat depression and anxiety in people with epilepsy more effectively, as these conditions are often underdiagnosed and undertreated. Screening tools like the Patient Health Questionnaire-9 (PHQ-9) have been validated for use in epilepsy patients, helping to identify those who need further mental health support. ^{4 6 7 11 12}

Who Is on the Research Team?

Heidi M. Munger Clary, MD, MPH

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults with epilepsy who have a clinic visit scheduled at least 7 days in advance. There are no specific exclusions, meaning it's open to anyone meeting the inclusion criteria.

Inclusion Criteria

I have an appointment at the epilepsy clinic in 7 days.

Exclusion Criteria

No exclusions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Randomized Delivery

Participants receive anxiety and depression screening instruments via one of four randomized delivery methods (REDCap email, Twilio text, EHR portal with reminder, EHR portal without reminder)

1 week

Follow-up

Participants are monitored for completion of screening instruments and clinic visit attendance

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Screening Questionnaires

Trial Overview The study is testing how well patients complete anxiety and depression questionnaires using different methods: REDCap versus Electronic Health Record (EHR) systems. It aims to see if one method leads to better completion rates.

How Is the Trial Designed?

Group I: Customized Email Prompt Active Control 1 Intervention

Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by an email with a REDCap email survey link.

Group II: Text Message Active Control 1 Intervention

Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.

Group III: Generic Electronic Health Record (EHR) portal email Active Control 1 Intervention

Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.

Group IV: EHR Portal with No Message Active Control 1 Intervention

Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of psychological screening in a tertiary epilepsy clinic. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Enhanced rates of detection and treatment of depression and anxiety disorders among adult patients with epilepsy using automated EMR-based screening. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Depression and anxiety in a community sample with epilepsy in Brazil. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Validity, reliability and cut-offs of the Patient Health Questionnaire-9 as a screening tool for depression among patients living with epilepsy in Rwanda. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Screening for depression in epilepsy clinics. A comparison of conventional and visual-analog methods. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Depressive and anxiety disorders in epilepsy: do they differ in their potential to worsen common antiepileptic drug-related adverse events? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Does screening for adverse effects improve health outcomes in epilepsy? A randomized trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of depression and anxiety on adverse event profiles in Korean people with epilepsy. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Psychiatric syndromes related to antiepileptic drugs. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The social context of anxiety and depression: exploring the role of anxiety and depression in the lives of Australian adults with epilepsy. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A primary healthcare screening tool to identify depression and anxiety disorders among people with epilepsy in Zambia. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Can family members reliably assess mood and suicidal ideation in individuals with epilepsy? [2023]