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

Trial Summary

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 data supports the effectiveness of the treatment Project UPLIFT for Epilepsy?

Project UPLIFT, a telephone-based program, has been shown to reduce depressive symptoms in people with epilepsy, which is important because depression can increase seizure activity. In a study with Hispanic adults with epilepsy, those who participated in UPLIFT had fewer depressive symptoms compared to those who received usual care, suggesting the program's potential benefits for mental health in this population. ^{1 2 3 4 5}

What safety data exists for Project UPLIFT for Epilepsy?

The SKATE study found that levetiracetam, a drug used in epilepsy treatment, is generally safe with mild-to-moderate side effects like sleepiness, fatigue, dizziness, and headache. Serious side effects were rare, occurring in only 1% of patients. ^{6 7 8 9 10}

How is the treatment Project UPLIFT for Epilepsy different from other treatments for epilepsy?

Project UPLIFT is unique because it is a telephone-based program that focuses on managing depression in people with epilepsy through mindfulness-based cognitive therapy (MBCT). Unlike traditional treatments that may focus on medication, UPLIFT provides group telehealth sessions to teach depression management skills, which can also help reduce seizure activity linked to depression. ^{1 2 3 4 11}

What is the purpose of this trial?

This study tests Project Using Practice and Learning to Increase Favorable Thoughts (UPLIFT) which is a Mindfulness-based Cognitive Behavioral Therapy program teaching participants with epilepsy methods that include challenging thoughts, behavioral activation, coping, problem-solving, and mindfulness, for well-being and costs. Project UPLIFT is delivered as weekly sessions over 8 weeks.

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Telephone-based depression self-management in Hispanic adults with epilepsy: a pilot randomized controlled trial. [2021]

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

Project UPLIFT: Adoption and implementation experiences of an epilepsy self-management program. [2023]

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

The impact of a depression self-management intervention on seizure activity. [2023]

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

A comprehensive, interdisciplinary approach to the care of the institutionalized person with epilepsy. [2019]

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

Improved outcomes in pediatric epilepsy surgery: the UCLA experience, 1986-2008. [2021]

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

Clinical adult outcome 11-30 years after pediatric epilepsy surgery: Complications and other surgical adverse events, seizure control, and cure of epilepsy. [2023]

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

Standardized reporting of complications of epilepsy surgery and invasive monitoring: A single-center retrospective study. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

[Efficacy and Safety of Levetiracetam as an Add-on Therapy for Symptomatic Refractory Epilepsy Treated in a Department of Neurosurgery]. [2018]

9. Poland pubmed.ncbi.nlm.nih.gov

Pattern of adverse events of antiepileptic drugs: results of the aESCAPE study in Poland. [2022]

10. Netherlands 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. [2018]

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

Preferred practices for rescue treatment of seizure clusters: A consensus-driven, multi-stakeholder approach. [2021]