Project UPLIFT for Epilepsy

Overseen By Katie Bullinger, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Cognitive impairment

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

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called Project UPLIFT, a therapy designed to help people with epilepsy improve their mental well-being. The program combines mindfulness, which involves paying attention to the present moment, and cognitive behavioral therapy, a method to change negative thinking patterns, to help participants better manage their thoughts and emotions. Participants will attend group sessions once a week for eight weeks. This program may suit adults who have epilepsy, speak English, and have regular access to a phone or computer. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance mental health support for those with epilepsy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on therapy sessions rather than medication changes.

What prior data suggests that Project UPLIFT is safe for participants with epilepsy?

Research has shown that Project UPLIFT is safe for people with epilepsy. Studies have found that this program can reduce depression symptoms and even decrease the number of seizures. This therapy teaches participants how to manage thoughts and feelings without medication. Consequently, no harmful side effects have been reported. This method is generally well-tolerated, as it emphasizes mental techniques rather than physical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for epilepsy, which often include medications like antiepileptic drugs to control seizures, Project UPLIFT focuses on mental health and quality of life. This program is unique because it's a group-based intervention designed to reduce depressive symptoms and increase knowledge and skills in people with epilepsy. Researchers are excited about Project UPLIFT because it offers a holistic approach that addresses the psychological aspects of living with epilepsy, potentially improving overall well-being beyond just managing seizures.

What evidence suggests that Project UPLIFT is effective for epilepsy?

Research has shown that Project UPLIFT, the treatment under study in this trial, can improve the quality of life for people with epilepsy. One study found that it helps reduce depression symptoms and prevents major depressive episodes. Another study discovered that Project UPLIFT can even lower the number of seizures people experience. These benefits arise from a type of therapy that teaches skills like challenging negative thoughts and practicing mindfulness. Overall, the program has demonstrated positive effects on both mental health and seizure control. ^{1 2 3 6 7}

Who Is on the Research Team?

David H Howard, PhD

Principal Investigator

Emory University

Cam Escoffery, PhD, MPH

Principal Investigator

Emory University

Katie Bullinger, MD, PhD

Principal Investigator

Emory University

Robin McGee, PhD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who have epilepsy, can speak English, and have access to a phone or computer. It's not specified who cannot participate.

Inclusion Criteria

I have access to a phone or computer.

I have been diagnosed with epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Project UPLIFT program, a Mindfulness-based Cognitive Behavioral Therapy, delivered as weekly sessions over 8 weeks

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Project UPLIFT

Trial Overview The study is evaluating Project UPLIFT, a Mindfulness-based Cognitive Behavioral Therapy program designed to improve well-being in people with epilepsy through weekly sessions over two months.

How Is the Trial Designed?

Group I: Project UPLIFT Experimental Treatment 1 Intervention

Adults with epilepsy participating in a group-based program for 8 weeks. Project UPLIFT is designed to increase knowledge and skills, decrease depressive symptoms and improve quality of life.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

The UPLIFT program, an 8-session telehealth intervention for people with epilepsy, has been positively received by community-based providers, with 76% of implementors planning to continue offering it due to its perceived effectiveness in addressing mental health issues.

Key factors for successful implementation included strong organizational support, participant interest, and the presence of program champions, although challenges like recruitment and funding were significant barriers to ongoing delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project UPLIFT: Adoption and implementation experiences of an epilepsy self-management program. McGee, RE., Patel, A., Drzymalla, EM., et al.[2023]

In a study of 309 epilepsy patients in Poland, 73.8% reported at least one adverse event (AE) while on antiepileptic drugs (AEDs), with cognitive disturbances, psychological issues, and sedation being the most common AEs.

Treatment modifications occurred in 22.3% of patients, primarily due to lack of efficacy (10.7%) and adverse events (5.2%), highlighting the need for careful monitoring of AED effectiveness and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pattern of adverse events of antiepileptic drugs: results of the aESCAPE study in Poland. Chmielewska, B., Lis, K., Rejdak, K., et al.[2022]

In a 16-week study involving 1541 patients with treatment-resistant partial seizures, levetiracetam (Keppra) was found to be effective as an add-on therapy, with a median seizure frequency reduction of 50.2% and 15.8% of patients becoming seizure-free.

Levetiracetam was generally well tolerated, with 50.5% of patients reporting mild-to-moderate adverse events like somnolence and dizziness, and only 1.0% experiencing serious adverse events, indicating a favorable safety profile for its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy. Steinhoff, BJ., Somerville, ER., Van Paesschen, W., et al.[2018]

The culturally adapted UPLIFT program, delivered via telephone in English or Spanish, was found to be feasible and acceptable for Hispanic adults with epilepsy, with high recruitment (76% consent rate) and retention rates (86-93%).

Participants in the UPLIFT program showed significantly lower rates of clinically significant depressive symptoms compared to usual care at 6 months (40% vs. 70%) and 12 months (47% vs. 70%), indicating its effectiveness in reducing depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-based depression self-management in Hispanic adults with epilepsy: a pilot randomized controlled trial. Spruill, TM., Friedman, D., Diaz, L., et al.[2021]

Project UPLIFT, an online intervention based on mindfulness-based cognitive therapy, significantly reduced the number of seizures in adults with epilepsy, with participants experiencing an average decrease of 3.2 seizures compared to an increase of 2.3 in the treatment-as-usual group.

While the intervention did not directly affect seizure severity, it did lead to a reduction in perceived severity through decreased depressive symptoms, indicating that improving mental health can have positive effects on seizure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a depression self-management intervention on seizure activity. Thompson, NJ., McGee, RE., Garcia-Williams, A., et al.[2023]

Citations

1. managingepilepsywell.org managingepilepsywell.org/uplift

UPLIFT — MEW Network This study tested the effectiveness of Project UPLIFT for preventing depression among people with epilepsy. Participants were 118 people with epilepsy and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4380523/

Expanding the Efficacy of Project UPLIFT Project UPLIFT was effective in preventing episodes of Major Depressive Disorder and further reducing depressive symptoms among people with epilepsy and mild-to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06865820

Implementation and Cost Evaluation of Project UPLIFT The effectiveness of Project UPLIFT is assessed by examining quality of life. The Quality of Life in Epilepsy (QOLIE-10) instrument has 10 questions about ...

4. aesnet.org aesnet.org/clinical-care/epilepsy-self-management/self-management-programs/project-uplift-using-practices-and-learning-to-increase-favorable-thoughts

Project UPLIFT: Using Practice and Learning to Increase ... Project UPLIFT is facilitated by a trained epilepsy professional and a peer. Groups of three to seven people with epilepsy meet by phone or telehealth platform.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525505019304226

The impact of a depression self-management intervention ... This study found that participating in Project UPLIFT directly reduced the number of seizures experienced by participants with epilepsy.

6. aesnet.org aesnet.org/abstractslisting/preventing-depression-in-epilepsy--project-uplift

PREVENTING-DEPRESSION-IN-EPILEPSY--PROJECT-UPLIFT A review of studies reported the rate of depression in people with epilepsy is between 32% and 48%. Project UPLIFT was originally developed as a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7002270/

The Impact of a Depression Self-Management Intervention ... This study found that participating in Project UPLIFT directly reduced the number of seizures experienced by participants with epilepsy.